Pulmonary Disease, Chronic ObstructivePhase 3NCT02296138
Comparing the Efficacy of Tiotropium + Olodaterol (5/5 µg) Fixed Dose Combination (FDC) Over Tiotropium 5µg in Reducing Moderate to Severe Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease.
A Phase 3 study testing olodaterol and tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 818 sites in 51 countries.
Trial summary
The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on moderate to severe COPD exacerbation in patients with severe to very severe COPD. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- olodaterol and tiotropium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,903 participants
- Where
- 818 sitesin 51 countries
- Study dates
- 13 Jan 2015to 29 Mar 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients, 40 years of age or older.
- Diagnosis of COPD with a documented post-bronchodilator Forced expiratory volume in one second (FEV1)< 60% of predicted normal and a post-bronchodilator FEV1/ forced vital capacity (FVC) <70% at Visit 1
- Documented history of at least one moderate to severe COPD exacerbation in the previous 12 months requiring treatment with systemic corticosteroids and/or antibiotics and/or related hospitalization.
- Symptomatically stable as defined by: no evidence of COPD exacerbation requiring use of either antibiotics and/or steroids 4 weeks prior to visit 1 and no evidence of change in their usual COPD medication 4 weeks prior to visit 1.
- Current or ex-smokers with a smoking history of more than 10 pack years.
Who cannot join
- Significant disease other than COPD.
- Clinically relevant abnormal baseline haematology, blood chemistry or creatinine > x2 ULN will be excluded regardless of clinical condition. ( A repeat laboratory evaluation can be conducted if deemed necessary by the investigator.)
- Current documented diagnosis of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma
- A diagnosis of thyrotoxicosis
- A history of myocardial infarction within 6 months of screening visit.
- Life-threatening cardiac arrhythmia.
Show all 20Show fewer
- Known active tuberculosis.
- Any malignancy unless free of disease for at least 5 years (patients with treated basal cell carcinoma or squamous cell skin cancers are allowed).
- A history of cystic fibrosis.
- Clinically relevant bronchiectasis.
- Patients with severe emphysema requiring endobronchial interventions within 6 months prior to screening
- A history of significant alcohol or drug abuse in the opinion of the investigator.
- Patients who have undergone thoracotomy with pulmonary resection
- Patients being treated with oral or patch ß-adrenergics.
- Patients being treated with oral corticosteroid medication at unstable doses
- Patients being treated with antibiotics for any reasons within 4 weeks of screening visit
- Patients being treated with PDE4 inhibitors within 3 months of screening visit
- Patients who have taken an investigational drug within one month or six half-lives
- Pregnant or nursing women.
- Women of childbearing potential not using a highly effective method of birth control.
Trial locations and contacts
818 sites in 51 countries.
818 sites in 51 countries
Japan124 sites
1237.19.81072 Boehringer Ingelheim Investigational Site
Aichi, Komaki
1237.19.81070 Boehringer Ingelheim Investigational Site
Aichi, Nagoya
1237.19.81073 Boehringer Ingelheim Investigational Site
Aichi, Nagoya
1237.19.81074 Boehringer Ingelheim Investigational Site
Aichi, Nagoya
1237.19.81071 Boehringer Ingelheim Investigational Site
Aichi, Obu
1237.19.81069 Boehringer Ingelheim Investigational Site
Aichi, Seto
1237.19.81030 Boehringer Ingelheim Investigational Site
Chiba, Chiba
1237.19.81031 Boehringer Ingelheim Investigational Site
Chiba, Kamogawa
1237.19.81061 Boehringer Ingelheim Investigational Site
Fukui, Fukui
1237.19.81116 Boehringer Ingelheim Investigational Site
Fukuoka, Fukuoka
1237.19.81112 Boehringer Ingelheim Investigational Site
Fukuoka, Kitakyushu-city
1237.19.81113 Boehringer Ingelheim Investigational Site
Fukuoka, Koga
1237.19.81111 Boehringer Ingelheim Investigational Site
Fukuoka, Kurume
1237.19.81114 Boehringer Ingelheim Investigational Site
Fukuoka, Yanagawa
1237.19.81115 Boehringer Ingelheim Investigational Site
Fukuoka, Yukuhashi
1237.19.81022 Boehringer Ingelheim Investigational Site
Fukushima, Fukushima
1237.19.81066 Boehringer Ingelheim Investigational Site
Gifu, Mizunami
1237.19.81065 Boehringer Ingelheim Investigational Site
Gifu, Ogaki
1237.19.81025 Boehringer Ingelheim Investigational Site
Gunma, Fujioka
1237.19.81027 Boehringer Ingelheim Investigational Site
Gunma, Maebashi
1237.19.81026 Boehringer Ingelheim Investigational Site
Gunma, Takasaki
1237.19.81101 Boehringer Ingelheim Investigational Site
Hiroshima, Fukuyama
1237.19.81104 Boehringer Ingelheim Investigational Site
Hiroshima, Hiroshima
1237.19.81102 Boehringer Ingelheim Investigational Site
Hiroshima, Kure
1237.19.81103 Boehringer Ingelheim Investigational Site
Hiroshima, Kure
1237.19.81010 Boehringer Ingelheim Investigational Site
Hokkaido, Asahikawa
1237.19.81007 Boehringer Ingelheim Investigational Site
Hokkaido, Chitose
1237.19.81012 Boehringer Ingelheim Investigational Site
Hokkaido, Hakodate
1237.19.81013 Boehringer Ingelheim Investigational Site
Hokkaido, Hakodate
1237.19.81009 Boehringer Ingelheim Investigational Site
Hokkaido, Obihiro
1237.19.81015 Boehringer Ingelheim Investigational Site
Hokkaido, Obihiro
1237.19.81016 Boehringer Ingelheim Investigational Site
Hokkaido, Otaru
1237.19.81001 Boehringer Ingelheim Investigational Site
Hokkaido, Sapporo
1237.19.81002 Boehringer Ingelheim Investigational Site
Hokkaido, Sapporo
1237.19.81004 Boehringer Ingelheim Investigational Site
Hokkaido, Sapporo
1237.19.81006 Boehringer Ingelheim Investigational Site
Hokkaido, Sapporo
1237.19.81008 Boehringer Ingelheim Investigational Site
Hokkaido, Sapporo
1237.19.81011 Boehringer Ingelheim Investigational Site
Hokkaido, Sapporo
1237.19.81014 Boehringer Ingelheim Investigational Site
Hokkaido, Sapporo
1237.19.81017 Boehringer Ingelheim Investigational Site
Hokkaido, Sapporo
1237.19.81003 Boehringer Ingelheim Investigational Site
Hokkaido, Tomakomai
1237.19.81090 Boehringer Ingelheim Investigational Site
Hyogo, Himeji
1237.19.81093 Boehringer Ingelheim Investigational Site
Hyogo, Himeji
1237.19.81091 Boehringer Ingelheim Investigational Site
Hyogo, Kobe
1237.19.81092 Boehringer Ingelheim Investigational Site
Hyogo, Nishinomiya
1237.19.81024 Boehringer Ingelheim Investigational Site
Ibaraki, Hitachinaka
1237.19.81129 Boehringer Ingelheim Investigational Site
Ibaraki, Inashiki-gun
1237.19.81023 Boehringer Ingelheim Investigational Site
Ibaraki, Naka-gun
1237.19.81060 Boehringer Ingelheim Investigational Site
Ishikawa, Kanazawa
1237.19.81018 Boehringer Ingelheim Investigational Site
Iwate, Morioka
1237.19.81108 Boehringer Ingelheim Investigational Site
Kagawa, Sakaide
1237.19.81107 Boehringer Ingelheim Investigational Site
Kagawa, Takamatsu
1237.19.81109 Boehringer Ingelheim Investigational Site
Kagawa, Takamatsu
1237.19.81118 Boehringer Ingelheim Investigational Site
Kagoshima, Kagoshima
1237.19.81050 Boehringer Ingelheim Investigational Site
Kanagawa, Isehara
1237.19.81052 Boehringer Ingelheim Investigational Site
Kanagawa, Kawasaki
1237.19.81053 Boehringer Ingelheim Investigational Site
Kanagawa, Kawasaki
1237.19.81055 Boehringer Ingelheim Investigational Site
Kanagawa, Kawasaki
1237.19.81054 Boehringer Ingelheim Investigational Site
Kanagawa, Sagamihara
1237.19.81056 Boehringer Ingelheim Investigational Site
Kanagawa, Sagamihara
1237.19.81049 Boehringer Ingelheim Investigational Site
Kanagawa, Yokohama
1237.19.81051 Boehringer Ingelheim Investigational Site
Kanagawa, Yokohama
1237.19.81110 Boehringer Ingelheim Investigational Site
Kochi, Kochi
1237.19.81130 Boehringer Ingelheim Investigational Site
Kochi, Nankoku
1237.19.81077 Boehringer Ingelheim Investigational Site
Kyoto, Kyoto
1237.19.81076 Boehringer Ingelheim Investigational Site
Mie, Matsusaka
1237.19.81005 Boehringer Ingelheim Investigational Site
Miyagi, Sendai
1237.19.81019 Boehringer Ingelheim Investigational Site
Miyagi, Sendai
1237.19.81020 Boehringer Ingelheim Investigational Site
Miyagi, Sendai
1237.19.81038 Boehringer Ingelheim Investigational Site
Miyagi, Sendai
1237.19.81064 Boehringer Ingelheim Investigational Site
Nagano, Matsumoto
1237.19.81063 Boehringer Ingelheim Investigational Site
Nagano, Matumoto
1237.19.81117 Boehringer Ingelheim Investigational Site
Nagasaki, Isahaya
1237.19.81095 Boehringer Ingelheim Investigational Site
Nara, Ikoma
1237.19.81057 Boehringer Ingelheim Investigational Site
Niigata, Niigata
1237.19.81058 Boehringer Ingelheim Investigational Site
Niigata, Niigata
1237.19.81059 Boehringer Ingelheim Investigational Site
Niigata, Niigata
1237.19.81125 Boehringer Ingelheim Investigational Site
Okayama
1237.19.81100 Boehringer Ingelheim Investigational Site
Okayama, Okayama
1237.19.81119 Boehringer Ingelheim Investigational Site
Okinawa, Urasoe
1237.19.81120 Boehringer Ingelheim Investigational Site
Okinawa, Uruma
1237.19.81089 Boehringer Ingelheim Investigational Site
Osaka, Ikeda
1237.19.81082 Boehringer Ingelheim Investigational Site
Osaka, Kishiwada
1237.19.81079 Boehringer Ingelheim Investigational Site
Osaka, Osaka
1237.19.81080 Boehringer Ingelheim Investigational Site
Osaka, Osaka
1237.19.81086 Boehringer Ingelheim Investigational Site
Osaka, Osaka
1237.19.81088 Boehringer Ingelheim Investigational Site
Osaka, Osaka
1237.19.81078 Boehringer Ingelheim Investigational Site
Osaka, Osakasayama
1237.19.81083 Boehringer Ingelheim Investigational Site
Osaka, Sakai
1237.19.81081 Boehringer Ingelheim Investigational Site
Osaka, Takatsuki
1237.19.81085 Boehringer Ingelheim Investigational Site
Osaka, Toyonaka
1237.19.81087 Boehringer Ingelheim Investigational Site
Osaka, Yao
1237.19.81028 Boehringer Ingelheim Investigational Site
Saitama, Koshigaya
1237.19.81029 Boehringer Ingelheim Investigational Site
Saitama, Saitama
1237.19.81128 Boehringer Ingelheim Investigational Site
Shiga
1237.19.81098 Boehringer Ingelheim Investigational Site
Shimane, Izumo
1237.19.81099 Boehringer Ingelheim Investigational Site
Shimane, Izumo
1237.19.81067 Boehringer Ingelheim Investigational Site
Shizuoka, Hamamatsu
1237.19.81068 Boehringer Ingelheim Investigational Site
Shizuoka, Shizuoka
1237.19.81123 Boehringer Ingelheim Investigational Site
Tochigi, Shimotsuke
1237.19.81122 Boehringer Ingelheim Investigational Site
Tokyo
1237.19.81126 Boehringer Ingelheim Investigational Site
Tokyo
1237.19.81075 Boehringer Ingelheim Investigational Site
Tokyo, Chiyoda-ku
1237.19.81036 Boehringer Ingelheim Investigational Site
Tokyo, Chuo-ku
1237.19.81040 Boehringer Ingelheim Investigational Site
Tokyo, Chuo-ku
1237.19.81039 Boehringer Ingelheim Investigational Site
Tokyo, Hachioji
1237.19.81035 Boehringer Ingelheim Investigational Site
Tokyo, Itabashi-ku
1237.19.81043 Boehringer Ingelheim Investigational Site
Tokyo, Itabashi-ku
1237.19.81046 Boehringer Ingelheim Investigational Site
Tokyo, Koto-ku
1237.19.81034 Boehringer Ingelheim Investigational Site
Tokyo, Meguro-ku
1237.19.81032 Boehringer Ingelheim Investigational Site
Tokyo, Minato-ku
1237.19.81047 Boehringer Ingelheim Investigational Site
Tokyo, Shinagawa-ku
1237.19.81033 Boehringer Ingelheim Investigational Site
Tokyo, Shinjuku-ku
1237.19.81041 Boehringer Ingelheim Investigational Site
Tokyo, Shinjuku-ku
1237.19.81042 Boehringer Ingelheim Investigational Site
Tokyo, Shinjuku-ku
1237.19.81044 Boehringer Ingelheim Investigational Site
Tokyo, Tachikawa
1237.19.81048 Boehringer Ingelheim Investigational Site
Tokyo, Toshima-ku
1237.19.81097 Boehringer Ingelheim Investigational Site
Wakayama, Hidaka-gun
1237.19.81096 Boehringer Ingelheim Investigational Site
Wakayama, Wakayama
1237.19.81124 Boehringer Ingelheim Investigational Site
Yamagata
1237.19.81021 Boehringer Ingelheim Investigational Site
Yamagata, Yonezawa
1237.19.81106 Boehringer Ingelheim Investigational Site
Yamaguchi, Iwakuni
1237.19.81105 Boehringer Ingelheim Investigational Site
Yamaguchi, Ube
1237.19.81062 Boehringer Ingelheim Investigational Site
Yamanashi, Kofu
United States117 sites
1237.19.10091 Boehringer Ingelheim Investigational Site
Abingdon, Virginia
1237.19.10039 Boehringer Ingelheim Investigational Site
Andalusia, Alabama
1237.19.10075 Boehringer Ingelheim Investigational Site
Ann Arbor, Michigan
1237.19.10117 Boehringer Ingelheim Investigational Site
Baltimore, Maryland
1237.19.10009 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
1237.19.10070 Boehringer Ingelheim Investigational Site
Boerne, Texas
1237.19.10048 Boehringer Ingelheim Investigational Site
Bowling Green, Kentucky
1237.19.10094 Boehringer Ingelheim Investigational Site
Brooklyn, New York
1237.19.10035 Boehringer Ingelheim Investigational Site
Burlington, North Carolina
1237.19.10014 Boehringer Ingelheim Investigational Site
Calabash, North Carolina
1237.19.10054 Boehringer Ingelheim Investigational Site
Charleston, South Carolina
1237.19.10098 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina
1237.19.10131 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina
1237.19.10031 Boehringer Ingelheim Investigational Site
Chesterfield, Missouri
1237.19.10008 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
1237.19.10042 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
1237.19.10029 Boehringer Ingelheim Investigational Site
Clearwater, Florida
1237.19.10106 Boehringer Ingelheim Investigational Site
Clearwater, Florida
1237.19.10083 Boehringer Ingelheim Investigational Site
Columbia, Maryland
1237.19.10086 Boehringer Ingelheim Investigational Site
Columbia, South Carolina
1237.19.10127 Boehringer Ingelheim Investigational Site
Columbus, Ohio
1237.19.10107 Boehringer Ingelheim Investigational Site
Corsicana, Texas
1237.19.10121 Boehringer Ingelheim Investigational Site
Dayton, Ohio
1237.19.10148 Boehringer Ingelheim Investigational Site
Dayton, Ohio
1237.19.10005 Boehringer Ingelheim Investigational Site
Delaware, Ohio
1237.19.10080 Boehringer Ingelheim Investigational Site
Duluth, Georgia
1237.19.10037 Boehringer Ingelheim Investigational Site
Eagle, Idaho
1237.19.10058 Boehringer Ingelheim Investigational Site
Easley, South Carolina
1237.19.10041 Boehringer Ingelheim Investigational Site
East Providence, Rhode Island
1237.19.10049 Boehringer Ingelheim Investigational Site
Elizabeth City, North Carolina
1237.19.10129 Boehringer Ingelheim Investigational Site
Erie, Pennsylvania
1237.19.10123 Boehringer Ingelheim Investigational Site
Everett, Washington
1237.19.10027 Boehringer Ingelheim Investigational Site
Fall River, Massachusetts
1237.19.10034 Boehringer Ingelheim Investigational Site
Farmington Hills, Michigan
1237.19.10069 Boehringer Ingelheim Investigational Site
Flagstaff, Arizona
1237.19.10077 Boehringer Ingelheim Investigational Site
Florence, Alabama
1237.19.10108 Boehringer Ingelheim Investigational Site
Fort Mitchell, Kentucky
1237.19.10153 Boehringer Ingelheim Investigational Site
Fort Worth, Texas
1237.19.10043 Boehringer Ingelheim Investigational Site
Fridley, Minnesota
1237.19.10023 Boehringer Ingelheim Investigational Site
Gaffney, South Carolina
1237.19.10030 Boehringer Ingelheim Investigational Site
Gaffney, South Carolina
1237.19.10011 Boehringer Ingelheim Investigational Site
Gainesville, Georgia
1237.19.10154 Boehringer Ingelheim Investigational Site
Gastonia, North Carolina
1237.19.10024 Boehringer Ingelheim Investigational Site
Greenville, South Carolina
1237.19.10128 Boehringer Ingelheim Investigational Site
Greenville, South Carolina
1237.19.10104 Boehringer Ingelheim Investigational Site
Hickory, North Carolina
1237.19.10072 Boehringer Ingelheim Investigational Site
Hollywood, Maryland
1237.19.10047 Boehringer Ingelheim Investigational Site
Houston, Texas
1237.19.10087 Boehringer Ingelheim Investigational Site
Huntersville, North Carolina
1237.19.10115 Boehringer Ingelheim Investigational Site
Jasper, Alabama
1237.19.10126 Boehringer Ingelheim Investigational Site
Johnston, Rhode Island
1237.19.10147 Boehringer Ingelheim Investigational Site
Kettering, Ohio
1237.19.10111 Boehringer Ingelheim Investigational Site
Killeen, Texas
1237.19.10059 Boehringer Ingelheim Investigational Site
Kingwood, Texas
1237.19.10157 Boehringer Ingelheim Investigational Site
Lafayette, Colorado
1237.19.10137 Boehringer Ingelheim Investigational Site
Larchmont, New York
1237.19.10112 Boehringer Ingelheim Investigational Site
Lawrenceville, Georgia
1237.19.10110 Boehringer Ingelheim Investigational Site
Lincoln, California
1237.19.10118 Boehringer Ingelheim Investigational Site
Los Angeles, California
1237.19.10076 Boehringer Ingelheim Investigational Site
Lynchburg, Virginia
1237.19.10081 Boehringer Ingelheim Investigational Site
Marlton, New Jersey
1237.19.10061 Boehringer Ingelheim Investigational Site
McKinney, Texas
1237.19.10021 Boehringer Ingelheim Investigational Site
Medford, Oregon
1237.19.10097 Boehringer Ingelheim Investigational Site
Missoula, Montana
1237.19.10001 Boehringer Ingelheim Investigational Site
Morgantown, West Virginia
1237.19.10144 Boehringer Ingelheim Investigational Site
Mt. Pleasant, South Carolina
1237.19.10122 Boehringer Ingelheim Investigational Site
Muncie, Indiana
1237.19.10071 Boehringer Ingelheim Investigational Site
Myrtle Beach, South Carolina
1237.19.10109 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana
1237.19.10138 Boehringer Ingelheim Investigational Site
North Dartmouth, Massachusetts
1237.19.10133 Boehringer Ingelheim Investigational Site
Norwalk, Connecticut
1237.19.10130 Boehringer Ingelheim Investigational Site
O'Fallon, Illinois
1237.19.10140 Boehringer Ingelheim Investigational Site
Oaks, Pennsylvania
1237.19.10099 Boehringer Ingelheim Investigational Site
Old Point Station, South Carolina
1237.19.10095 Boehringer Ingelheim Investigational Site
Opelousas, Louisiana
1237.19.10020 Boehringer Ingelheim Investigational Site
Orlando, Florida
1237.19.10085 Boehringer Ingelheim Investigational Site
Peoria, Arizona
1237.19.10003 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
1237.19.10019 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
1237.19.10006 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania
1237.19.10136 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania
1237.19.10151 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania
1237.19.10074 Boehringer Ingelheim Investigational Site
Poway, California
1237.19.10007 Boehringer Ingelheim Investigational Site
Rapid City, South Dakota
1237.19.10060 Boehringer Ingelheim Investigational Site
Reno, Nevada
1237.19.10040 Boehringer Ingelheim Investigational Site
Richmond, Virginia
1237.19.10089 Boehringer Ingelheim Investigational Site
Richmond, Virginia
1237.19.10065 Boehringer Ingelheim Investigational Site
River Forest, Illinois
1237.19.10096 Boehringer Ingelheim Investigational Site
Rochester, Minnesota
1237.19.10025 Boehringer Ingelheim Investigational Site
Rock Hill, South Carolina
1237.19.10101 Boehringer Ingelheim Investigational Site
Saint Charles, Missouri
1237.19.10050 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1237.19.10053 Boehringer Ingelheim Investigational Site
Shelby, North Carolina
1237.19.10113 Boehringer Ingelheim Investigational Site
Shreveport, Louisiana
1237.19.10139 Boehringer Ingelheim Investigational Site
Shreveport, Louisiana
1237.19.10033 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina
1237.19.10036 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina
1237.19.10120 Boehringer Ingelheim Investigational Site
Spokane, Washington
1237.19.10051 Boehringer Ingelheim Investigational Site
St Louis, Missouri
1237.19.10084 Boehringer Ingelheim Investigational Site
St Louis, Missouri
1237.19.10000 Boehringer Ingelheim Investigational Site
St. Petersburg, Florida
1237.19.10135 Boehringer Ingelheim Investigational Site
St. Petersburg, Florida
1237.19.10093 Boehringer Ingelheim Investigational Site
Stamford, Connecticut
1237.19.10143 Boehringer Ingelheim Investigational Site
Syracuse, New York
1237.19.10092 Boehringer Ingelheim Investigational Site
Tacoma, Washington
1237.19.10145 Boehringer Ingelheim Investigational Site
Tamarac, Florida
1237.19.10066 Boehringer Ingelheim Investigational Site
Tampa, Florida
1237.19.10055 Boehringer Ingelheim Investigational Site
Toledo, Ohio
1237.19.10063 Boehringer Ingelheim Investigational Site
Topeka, Kansas
1237.19.10082 Boehringer Ingelheim Investigational Site
Traverse City, Michigan
1237.19.10146 Boehringer Ingelheim Investigational Site
Tulsa, Oklahoma
1237.19.10010 Boehringer Ingelheim Investigational Site
Union, South Carolina
1237.19.10016 Boehringer Ingelheim Investigational Site
West Allis, Wisconsin
1237.19.10142 Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado
1237.19.10062 Boehringer Ingelheim Investigational Site
Wilmington, North Carolina
1237.19.10032 Boehringer Ingelheim Investigational Site
Winter Park, Florida
1237.19.10103 Boehringer Ingelheim Investigational Site
Worcester, Massachusetts
Germany64 sites
1237.19.49041 Boehringer Ingelheim Investigational Site
Ahlen
1237.19.49004 Boehringer Ingelheim Investigational Site
Aschaffenburg
1237.19.49059 Boehringer Ingelheim Investigational Site
Augsburg
1237.19.49042 Boehringer Ingelheim Investigational Site
Bad Wörishofen
1237.19.49072 Boehringer Ingelheim Investigational Site
Bamberg
1237.19.49024 Boehringer Ingelheim Investigational Site
Bergisch Gladbach
1237.19.49009 Boehringer Ingelheim Investigational Site
Berlin
1237.19.49011 Boehringer Ingelheim Investigational Site
Berlin
1237.19.49018 Boehringer Ingelheim Investigational Site
Berlin
1237.19.49025 Boehringer Ingelheim Investigational Site
Berlin
1237.19.49026 Boehringer Ingelheim Investigational Site
Berlin
1237.19.49029 Boehringer Ingelheim Investigational Site
Berlin
1237.19.49035 Boehringer Ingelheim Investigational Site
Berlin
1237.19.49043 Boehringer Ingelheim Investigational Site
Berlin
1237.19.49058 Boehringer Ingelheim Investigational Site
Berlin
1237.19.49065 Boehringer Ingelheim Investigational Site
Berlin
1237.19.49076 Boehringer Ingelheim Investigational Site
Bielefeld
1237.19.49064 Boehringer Ingelheim Investigational Site
Bochum
1237.19.49048 Boehringer Ingelheim Investigational Site
Bonn
1237.19.49034 Boehringer Ingelheim Investigational Site
Cologne
1237.19.49002 Boehringer Ingelheim Investigational Site
Düren
1237.19.49012 Boehringer Ingelheim Investigational Site
Essen
1237.19.49017 Boehringer Ingelheim Investigational Site
Frankfurt
1237.19.49019 Boehringer Ingelheim Investigational Site
Frankfurt
1237.19.49052 Boehringer Ingelheim Investigational Site
Frankfurt
1237.19.49062 Boehringer Ingelheim Investigational Site
Frankfurt
1237.19.49044 Boehringer Ingelheim Investigational Site
Fulda
1237.19.49057 Boehringer Ingelheim Investigational Site
Fürstenwalde
1237.19.49001 Boehringer Ingelheim Investigational Site
Großhansdorf
1237.19.49008 Boehringer Ingelheim Investigational Site
Gütersloh
1237.19.49028 Boehringer Ingelheim Investigational Site
Halle
1237.19.49038 Boehringer Ingelheim Investigational Site
Hamburg
1237.19.49055 Boehringer Ingelheim Investigational Site
Hanover
1237.19.49077 Boehringer Ingelheim Investigational Site
Hanover
1237.19.49022 Boehringer Ingelheim Investigational Site
Heidelberg
1237.19.49056 Boehringer Ingelheim Investigational Site
Höchstädt
1237.19.49049 Boehringer Ingelheim Investigational Site
Kiel
1237.19.49005 Boehringer Ingelheim Investigational Site
Koblenz
1237.19.49073 Boehringer Ingelheim Investigational Site
Landsberg am Lech
1237.19.49003 Boehringer Ingelheim Investigational Site
Leipzig
1237.19.49007 Boehringer Ingelheim Investigational Site
Leipzig
1237.19.49030 Boehringer Ingelheim Investigational Site
Leipzig
1237.19.49061 Boehringer Ingelheim Investigational Site
Leipzig
1237.19.49063 Boehringer Ingelheim Investigational Site
Leipzig
1237.19.49070 Boehringer Ingelheim Investigational Site
Leipzig
1237.19.49010 Boehringer Ingelheim Investigational Site
Leverkusen
1237.19.49037 Boehringer Ingelheim Investigational Site
Lübeck
1237.19.49016 Boehringer Ingelheim Investigational Site
Mannheim
1237.19.49046 Boehringer Ingelheim Investigational Site
Mannheim
1237.19.49036 Boehringer Ingelheim Investigational Site
Marburg
1237.19.49054 Boehringer Ingelheim Investigational Site
Minden
1237.19.49006 Boehringer Ingelheim Investigational Site
München
1237.19.49013 Boehringer Ingelheim Investigational Site
München
1237.19.49047 Boehringer Ingelheim Investigational Site
Paderborn
1237.19.49014 Boehringer Ingelheim Investigational Site
Peine
1237.19.49074 Boehringer Ingelheim Investigational Site
Potsdam
1237.19.49045 Boehringer Ingelheim Investigational Site
Radebeul
1237.19.49053 Boehringer Ingelheim Investigational Site
Rheine
1237.19.49060 Boehringer Ingelheim Investigational Site
Rüdersdorf
1237.19.49050 Boehringer Ingelheim Investigational Site
Solingen
1237.19.49032 Boehringer Ingelheim Investigational Site
Teuchern
1237.19.49051 Boehringer Ingelheim Investigational Site
Wardenburg
1237.19.49040 Boehringer Ingelheim Investigational Site
Wiesloch
1237.19.49023 Boehringer Ingelheim Investigational Site
Witten
Russia44 sites
1237.19.70004 Boehringer Ingelheim Investigational Site
Arkhangelsk
1237.19.70028 Boehringer Ingelheim Investigational Site
Barnaul
1237.19.70017 Boehringer Ingelheim Investigational Site
Chelyabinsk
1237.19.70014 Boehringer Ingelheim Investigational Site
Gatchina
1237.19.70051 Boehringer Ingelheim Investigational Site
Ivanovo
1237.19.70050 Boehringer Ingelheim Investigational Site
Kazan'
1237.19.70006 Boehringer Ingelheim Investigational Site
Kemerovo
1237.19.70023 Boehringer Ingelheim Investigational Site
Kemerovo
1237.19.70031 Boehringer Ingelheim Investigational Site
Kirov
1237.19.70007 Boehringer Ingelheim Investigational Site
Lomonosov
1237.19.70002 Boehringer Ingelheim Investigational Site
Moscow
1237.19.70003 Boehringer Ingelheim Investigational Site
Moscow
1237.19.70032 Boehringer Ingelheim Investigational Site
Moscow
1237.19.70047 Boehringer Ingelheim Investigational Site
Moscow
1237.19.70024 Boehringer Ingelheim Investigational Site
Novosibirsk
1237.19.70025 Boehringer Ingelheim Investigational Site
Novosibirsk
1237.19.70034 Boehringer Ingelheim Investigational Site
Novosibirsk
1237.19.70035 Boehringer Ingelheim Investigational Site
Omsk
1237.19.70033 Boehringer Ingelheim Investigational Site
Penza
1237.19.70021 Boehringer Ingelheim Investigational Site
Pskov
1237.19.70052 Boehringer Ingelheim Investigational Site
Rosto-on-Don
1237.19.70015 Boehringer Ingelheim Investigational Site
Rostov-on-Don
1237.19.70009 Boehringer Ingelheim Investigational Site
Saint Petersburg
1237.19.70010 Boehringer Ingelheim Investigational Site
Saint Petersburg
1237.19.70011 Boehringer Ingelheim Investigational Site
Saint Petersburg
1237.19.70012 Boehringer Ingelheim Investigational Site
Saint Petersburg
1237.19.70018 Boehringer Ingelheim Investigational Site
Saint Petersburg
1237.19.70019 Boehringer Ingelheim Investigational Site
Saint Petersburg
1237.19.70022 Boehringer Ingelheim Investigational Site
Saint Petersburg
1237.19.70038 Boehringer Ingelheim Investigational Site
Saint Petersburg
1237.19.70041 Boehringer Ingelheim Investigational Site
Saint Petersburg
1237.19.70042 Boehringer Ingelheim Investigational Site
Saint Petersburg
1237.19.70046 Boehringer Ingelheim Investigational Site
Saint Petersburg
1237.19.70048 Boehringer Ingelheim Investigational Site
Saint Petersburg
1237.19.70049 Boehringer Ingelheim Investigational Site
Saint Petersburg
1237.19.70005 Boehringer Ingelheim Investigational Site
Saratov
1237.19.70040 Boehringer Ingelheim Investigational Site
Saratov
1237.19.70044 Boehringer Ingelheim Investigational Site
Saratov
1237.19.70008 Boehringer Ingelheim Investigational Site
Tomsk
1237.19.70026 Boehringer Ingelheim Investigational Site
Tomsk
1237.19.70037 Boehringer Ingelheim Investigational Site
Ulyanovsk
1237.19.70030 Boehringer Ingelheim Investigational Site
Volgograd
1237.19.70036 Boehringer Ingelheim Investigational Site
Yaroslavl
1237.19.70020 Boehringer Ingelheim Investigational Site
Yekaterinburg
Canada38 sites
1237.19.20018 Boehringer Ingelheim Investigational Site
Burlington, Ontario
1237.19.20011 Boehringer Ingelheim Investigational Site
Calgary, Alberta
1237.19.20020 Boehringer Ingelheim Investigational Site
Calgary, Alberta
1237.19.20035 Boehringer Ingelheim Investigational Site
Coquitlam, British Columbia
1237.19.20029 Boehringer Ingelheim Investigational Site
Corunna, Ontario
1237.19.20009 Boehringer Ingelheim Investigational Site
Courtice, Ontario
1237.19.20016 Boehringer Ingelheim Investigational Site
Edmonton, Alberta
1237.19.20025 Boehringer Ingelheim Investigational Site
Edmonton, Alberta
1237.19.20019 Boehringer Ingelheim Investigational Site
Grimsby, Ontario
1237.19.20017 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
1237.19.20026 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
1237.19.20038 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
1237.19.20034 Boehringer Ingelheim Investigational Site
Kelowna, British Columbia
1237.19.20022 Boehringer Ingelheim Investigational Site
London, Ontario
1237.19.20004 Boehringer Ingelheim Investigational Site
Longueuil, Quebec
1237.19.20041 Boehringer Ingelheim Investigational Site
Maple Ridge, British Columbia
1237.19.20021 Boehringer Ingelheim Investigational Site
Moncton, New Brunswick
1237.19.20032 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1237.19.20040 Boehringer Ingelheim Investigational Site
Ottawa, Ontario
1237.19.20008 Boehringer Ingelheim Investigational Site
Point Claire, Quebec
1237.19.20014 Boehringer Ingelheim Investigational Site
Québec, Quebec
1237.19.20006 Boehringer Ingelheim Investigational Site
Saint John, New Brunswick
1237.19.20031 Boehringer Ingelheim Investigational Site
Saint-Charles-Borromée, Quebec
1237.19.20030 Boehringer Ingelheim Investigational Site
Sarnia, Ontario
1237.19.20002 Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan
1237.19.20027 Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan
1237.19.20013 Boehringer Ingelheim Investigational Site
St. John's, Newfoundland and Labrador
1237.19.20023 Boehringer Ingelheim Investigational Site
Ste-Foy, Quebec
1237.19.20005 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1237.19.20037 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1237.19.20039 Boehringer Ingelheim Investigational Site
Trois-Rivières, Quebec
1237.19.20010 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
1237.19.20033 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
1237.19.20036 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
1237.19.20003 Boehringer Ingelheim Investigational Site
Victoriaville, Quebec
1237.19.20012 Boehringer Ingelheim Investigational Site
Waterloo, Ontario
1237.19.20007 Boehringer Ingelheim Investigational Site
Windsor, Ontario
1237.19.20015 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba
Poland29 sites
1237.19.48009 Boehringer Ingelheim Investigational Site
Bialystok
1237.19.48026 Boehringer Ingelheim Investigational Site
Bialystok
1237.19.48031 Boehringer Ingelheim Investigational Site
Bialystok
1237.19.48010 Boehringer Ingelheim Investigational Site
Bydgoszcz
1237.19.48029 Boehringer Ingelheim Investigational Site
Chojnice
1237.19.48001 Boehringer Ingelheim Investigational Site
Katowice
1237.19.48024 Boehringer Ingelheim Investigational Site
Kielce
1237.19.48005 Boehringer Ingelheim Investigational Site
Krakow
1237.19.48007 Boehringer Ingelheim Investigational Site
Krakow
1237.19.48015 Boehringer Ingelheim Investigational Site
Libiąż
1237.19.48006 Boehringer Ingelheim Investigational Site
Lodz
1237.19.48008 Boehringer Ingelheim Investigational Site
Lodz
1237.19.48025 Boehringer Ingelheim Investigational Site
Lublin
1237.19.48011 Boehringer Ingelheim Investigational Site
Olsztyn
1237.19.48013 Boehringer Ingelheim Investigational Site
Ostow Wielkopolski
1237.19.48019 Boehringer Ingelheim Investigational Site
Ostróda
1237.19.48020 Boehringer Ingelheim Investigational Site
Piaseczno
1237.19.48002 Boehringer Ingelheim Investigational Site
Poznan
1237.19.48004 Boehringer Ingelheim Investigational Site
Poznan
1237.19.48014 Boehringer Ingelheim Investigational Site
Poznan
1237.19.48016 Boehringer Ingelheim Investigational Site
Skierniewice
1237.19.48021 Boehringer Ingelheim Investigational Site
Świdnik
1237.19.48017 Boehringer Ingelheim Investigational Site
Szczecin
1237.19.48030 Boehringer Ingelheim Investigational Site
Tarnobrzeg
1237.19.48022 Boehringer Ingelheim Investigational Site
Warsaw
1237.19.48003 Boehringer Ingelheim Investigational Site
Wołomin
1237.19.48023 Boehringer Ingelheim Investigational Site
Wroclaw
1237.19.48018 Boehringer Ingelheim Investigational Site
Zawadzkie
1237.19.48012 Boehringer Ingelheim Investigational Site
Zgierz
India28 sites
1237.19.91016 Boehringer Ingelheim Investigational Site
Ahmadābād
1237.19.91013 Boehringer Ingelheim Investigational Site
Ahmedabad
1237.19.91040 Boehringer Ingelheim Investigational Site
Ahmedabad
1237.19.91032 Boehringer Ingelheim Investigational Site
Bangalore
1237.19.91004 Boehringer Ingelheim Investigational Site
Coimbatore
1237.19.91033 Boehringer Ingelheim Investigational Site
Gūrgaon
1237.19.91005 Boehringer Ingelheim Investigational Site
Hyderabad
1237.19.91019 Boehringer Ingelheim Investigational Site
Hyderabad
1237.19.91020 Boehringer Ingelheim Investigational Site
Hyderabad
1237.19.91025 Boehringer Ingelheim Investigational Site
Hyderabad
1237.19.91006 Boehringer Ingelheim Investigational Site
Jaipur
1237.19.91042 Boehringer Ingelheim Investigational Site
Jaipur
1237.19.91044 Boehringer Ingelheim Investigational Site
Jaipur
1237.19.91026 Boehringer Ingelheim Investigational Site
Karamsad
1237.19.91034 Boehringer Ingelheim Investigational Site
Kolkata
1237.19.91010 Boehringer Ingelheim Investigational Site
Ludhiana
1237.19.91007 Boehringer Ingelheim Investigational Site
Madurai
1237.19.91014 Boehringer Ingelheim Investigational Site
Mysore
1237.19.91021 Boehringer Ingelheim Investigational Site
Mysore
1237.19.91001 Boehringer Ingelheim Investigational Site
Nagpur
1237.19.91002 Boehringer Ingelheim Investigational Site
Nagpur
1237.19.91003 Boehringer Ingelheim Investigational Site
Nagpur
1237.19.91027 Boehringer Ingelheim Investigational Site
New Delhi
1237.19.91024 Boehringer Ingelheim Investigational Site
Panjim
1237.19.91023 Boehringer Ingelheim Investigational Site
Pune
1237.19.91035 Boehringer Ingelheim Investigational Site
Pune
1237.19.91008 Boehringer Ingelheim Investigational Site
Vellore
1237.19.91028 Boehringer Ingelheim Investigational Site
Visakhapatnam
Spain26 sites
1237.19.34017 Boehringer Ingelheim Investigational Site
Alicante
1237.19.34025 Boehringer Ingelheim Investigational Site
Aranjuez
1237.19.34024 Boehringer Ingelheim Investigational Site
Badalona
1237.19.34011 Boehringer Ingelheim Investigational Site
Barakaldo (Bilbao)
1237.19.34012 Boehringer Ingelheim Investigational Site
Barcelona
1237.19.34021 Boehringer Ingelheim Investigational Site
Barcelona
1237.19.34007 Boehringer Ingelheim Investigational Site
Cáceres
1237.19.34028 Boehringer Ingelheim Investigational Site
Centelles
1237.19.34015 Boehringer Ingelheim Investigational Site
Girona
1237.19.34027 Boehringer Ingelheim Investigational Site
Granollers (Barcelona)
1237.19.34003 Boehringer Ingelheim Investigational Site
L'Hospitalet Llobregat (bcn)
1237.19.34001 Boehringer Ingelheim Investigational Site
Liencres (Pielagos)
1237.19.34005 Boehringer Ingelheim Investigational Site
Madrid
1237.19.34020 Boehringer Ingelheim Investigational Site
Madrid
1237.19.34009 Boehringer Ingelheim Investigational Site
Málaga
1237.19.34019 Boehringer Ingelheim Investigational Site
Mérida
1237.19.34013 Boehringer Ingelheim Investigational Site
Palma de Mallorca
1237.19.34004 Boehringer Ingelheim Investigational Site
Pamplona
1237.19.34018 Boehringer Ingelheim Investigational Site
Pozuelo de Alarcón
1237.19.34023 Boehringer Ingelheim Investigational Site
Sabadell
1237.19.34014 Boehringer Ingelheim Investigational Site
Seville
1237.19.34006 Boehringer Ingelheim Investigational Site
Valencia
1237.19.34029 Boehringer Ingelheim Investigational Site
Valladolid
1237.19.34026 Boehringer Ingelheim Investigational Site
Vic
1237.19.34022 Boehringer Ingelheim Investigational Site
Vilanova i la Geltrú
1237.19.34002 Boehringer Ingelheim Investigational Site
Zaragoza
Italy22 sites
1237.19.39011 Boehringer Ingelheim Investigational Site
Cittadella (PD)
1237.19.39014 Boehringer Ingelheim Investigational Site
Ferrara
1237.19.39010 Boehringer Ingelheim Investigational Site
Messina
1237.19.39002 Boehringer Ingelheim Investigational Site
Milan
1237.19.39016 Boehringer Ingelheim Investigational Site
Milan
1237.19.39023 Boehringer Ingelheim Investigational Site
Milan
1237.19.39015 Boehringer Ingelheim Investigational Site
Monza
1237.19.39025 Boehringer Ingelheim Investigational Site
Padova
1237.19.39024 Boehringer Ingelheim Investigational Site
Palermo
1237.19.39006 Boehringer Ingelheim Investigational Site
Parma
1237.19.39005 Boehringer Ingelheim Investigational Site
Pavia
1237.19.39007 Boehringer Ingelheim Investigational Site
Perugia
1237.19.39008 Boehringer Ingelheim Investigational Site
Piacenza
1237.19.39001 Boehringer Ingelheim Investigational Site
Pisa
1237.19.39020 Boehringer Ingelheim Investigational Site
Pisa
1237.19.39013 Boehringer Ingelheim Investigational Site
Pordenone
1237.19.39003 Boehringer Ingelheim Investigational Site
Roma
1237.19.39004 Boehringer Ingelheim Investigational Site
Roma
1237.19.39012 Boehringer Ingelheim Investigational Site
Roma
1237.19.39021 Boehringer Ingelheim Investigational Site
San Pietro Vernotico (BR)
1237.19.39017 Boehringer Ingelheim Investigational Site
Sassari
1237.19.39019 Boehringer Ingelheim Investigational Site
Scafati (SA)
France19 sites
1237.19.33016 Boehringer Ingelheim Investigational Site
Cannes
1237.19.33014 Boehringer Ingelheim Investigational Site
La Tronche
1237.19.33013 Boehringer Ingelheim Investigational Site
Marseille
1237.19.33020 Boehringer Ingelheim Investigational Site
Marseille
1237.19.33003 Boehringer Ingelheim Investigational Site
Montpellier
1237.19.33024 Boehringer Ingelheim Investigational Site
Nantes
1237.19.33017 Boehringer Ingelheim Investigational Site
Nice
1237.19.33018 Boehringer Ingelheim Investigational Site
Nîmes
1237.19.33019 Boehringer Ingelheim Investigational Site
Nîmes
1237.19.33001 Boehringer Ingelheim Investigational Site
Paris
1237.19.33002 Boehringer Ingelheim Investigational Site
Pessac
1237.19.33006 Boehringer Ingelheim Investigational Site
Reims
1237.19.33021 Boehringer Ingelheim Investigational Site
Rennes
1237.19.33012 Boehringer Ingelheim Investigational Site
Saint Pierre - La Réunion
1237.19.33005 Boehringer Ingelheim Investigational Site
Saint-Laurent-du-Var
1237.19.33022 Boehringer Ingelheim Investigational Site
Strasbourg
1237.19.33007 Boehringer Ingelheim Investigational Site
Toulouse
1237.19.33023 Boehringer Ingelheim Investigational Site
Tours
1237.19.33010 Boehringer Ingelheim Investigational Site
Vieux-Condé
Argentina17 sites
1237.19.54015 Boehringer Ingelheim Investigational Site
Bahía Blanca
1237.19.54014 Boehringer Ingelheim Investigational Site
Berazategui
1237.19.54003 Boehringer Ingelheim Investigational Site
Capital Federal
1237.19.54004 Boehringer Ingelheim Investigational Site
Capital Federal
1237.19.54007 Boehringer Ingelheim Investigational Site
Capital Federal
1237.19.54011 Boehringer Ingelheim Investigational Site
Ciudad de Buenos Aires
1237.19.54018 Boehringer Ingelheim Investigational Site
Ciudad de Buenos Aires
1237.19.54010 Boehringer Ingelheim Investigational Site
La Plata
1237.19.54012 Boehringer Ingelheim Investigational Site
Mar del Plata
1237.19.54017 Boehringer Ingelheim Investigational Site
Mar del Plata
1237.19.54019 Boehringer Ingelheim Investigational Site
Mar del Plata
1237.19.54005 Boehringer Ingelheim Investigational Site
Mendoza
1237.19.54006 Boehringer Ingelheim Investigational Site
Quilmes
1237.19.54013 Boehringer Ingelheim Investigational Site
Rosario
1237.19.54016 Boehringer Ingelheim Investigational Site
San Isidro
1237.19.54001 Boehringer Ingelheim Investigational Site
San Miguel de Tucumán
1237.19.54002 Boehringer Ingelheim Investigational Site
San Miguel de Tucumán
Turkey (Türkiye)17 sites
1237.19.90006 Boehringer Ingelheim Investigational Site
Ankara
1237.19.90007 Boehringer Ingelheim Investigational Site
Ankara
1237.19.90015 Boehringer Ingelheim Investigational Site
Ankara
1237.19.90016 Boehringer Ingelheim Investigational Site
Ankara
1237.19.90008 Boehringer Ingelheim Investigational Site
Antalya
1237.19.90010 Boehringer Ingelheim Investigational Site
Bursa
1237.19.90002 Boehringer Ingelheim Investigational Site
Denizli
1237.19.90012 Boehringer Ingelheim Investigational Site
Istanbul
1237.19.90013 Boehringer Ingelheim Investigational Site
Istanbul
1237.19.90014 Boehringer Ingelheim Investigational Site
Istanbul
1237.19.90003 Boehringer Ingelheim Investigational Site
Izmir
1237.19.90004 Boehringer Ingelheim Investigational Site
Izmir
1237.19.90005 Boehringer Ingelheim Investigational Site
Izmir
1237.19.90011 Boehringer Ingelheim Investigational Site
Izmir
1237.19.90001 Boehringer Ingelheim Investigational Site
Kocaeli
1237.19.90009 Boehringer Ingelheim Investigational Site
Konya
1237.19.90000 Boehringer Ingelheim Investigational Site
Mersin
Netherlands16 sites
1237.19.31017 Boehringer Ingelheim Investigational Site
Alkmaar
1237.19.31015 Boehringer Ingelheim Investigational Site
Almelo
1237.19.31011 Boehringer Ingelheim Investigational Site
Amsterdam
1237.19.31014 Boehringer Ingelheim Investigational Site
Assen
1237.19.31001 Boehringer Ingelheim Investigational Site
Breda
1237.19.31003 Boehringer Ingelheim Investigational Site
Ede
1237.19.31002 Boehringer Ingelheim Investigational Site
Eindhoven
1237.19.31005 Boehringer Ingelheim Investigational Site
Groningen
1237.19.31010 Boehringer Ingelheim Investigational Site
Harderwijk
1237.19.31012 Boehringer Ingelheim Investigational Site
Hoofddorp
1237.19.31013 Boehringer Ingelheim Investigational Site
Hoorn
1237.19.31018 Boehringer Ingelheim Investigational Site
Leeuwarden
1237.19.31016 Boehringer Ingelheim Investigational Site
Leiden
1237.19.31008 Boehringer Ingelheim Investigational Site
Rotterdam
1237.19.31007 Boehringer Ingelheim Investigational Site
Sittard - Geleen
1237.19.31004 Boehringer Ingelheim Investigational Site
Zutphen
Hungary15 sites
1237.19.36006 Boehringer Ingelheim Investigational Site
Budapest
1237.19.36012 Boehringer Ingelheim Investigational Site
Budapest
1237.19.36005 Boehringer Ingelheim Investigational Site
Debrecen
1237.19.36015 Boehringer Ingelheim Investigational Site
Debrecen
1237.19.36008 Boehringer Ingelheim Investigational Site
Edelény
1237.19.36011 Boehringer Ingelheim Investigational Site
Farkasgyepű
1237.19.36002 Boehringer Ingelheim Investigational Site
Gödöllő
1237.19.36014 Boehringer Ingelheim Investigational Site
Hajdúnánás
1237.19.36013 Boehringer Ingelheim Investigational Site
Kapuvár
1237.19.36009 Boehringer Ingelheim Investigational Site
Komárom
1237.19.36007 Boehringer Ingelheim Investigational Site
Nyíregyháza
1237.19.36003 Boehringer Ingelheim Investigational Site
Pécs
1237.19.36004 Boehringer Ingelheim Investigational Site
Pécs
1237.19.36010 Boehringer Ingelheim Investigational Site
Százhalombatta
1237.19.36001 Boehringer Ingelheim Investigational Site
Szeged
Australia12 sites
1237.19.61013 Boehringer Ingelheim Investigational Site
Box Hill, Victoria
1237.19.61010 Boehringer Ingelheim Investigational Site
Cairns, Queensland
1237.19.61012 Boehringer Ingelheim Investigational Site
Campbelltown, New South Wales
1237.19.61006 Boehringer Ingelheim Investigational Site
Chermside, Queensland
1237.19.61001 Boehringer Ingelheim Investigational Site
Daw Park, South Australia
1237.19.61002 Boehringer Ingelheim Investigational Site
Kent Town, South Australia
1237.19.61011 Boehringer Ingelheim Investigational Site
Kogarah, New South Wales
1237.19.61003 Boehringer Ingelheim Investigational Site
Melbourne, Victoria
1237.19.61004 Boehringer Ingelheim Investigational Site
Murdoch, Western Australia
1237.19.61009 Boehringer Ingelheim Investigational Site
Parkville, Victoria
1237.19.61008 Boehringer Ingelheim Investigational Site
Randwick, New South Wales
1237.19.61007 Boehringer Ingelheim Investigational Site
Woodville, South Australia
Brazil12 sites
1237.19.55007 Boehringer Ingelheim Investigational Site
Belo Horizonte
1237.19.55013 Boehringer Ingelheim Investigational Site
Botucatu
1237.19.55011 Boehringer Ingelheim Investigational Site
Goiânia
1237.19.55002 Boehringer Ingelheim Investigational Site
Porto Alegre
1237.19.55006 Boehringer Ingelheim Investigational Site
Porto Alegre
1237.19.55010 Boehringer Ingelheim Investigational Site
Porto Alegre
1237.19.55012 Boehringer Ingelheim Investigational Site
Porto Alegre
1237.19.55014 Boehringer Ingelheim Investigational Site
Santo André
1237.19.55001 Boehringer Ingelheim Investigational Site
São Paulo
1237.19.55005 Boehringer Ingelheim Investigational Site
São Paulo
1237.19.55008 Boehringer Ingelheim Investigational Site
São Paulo
1237.19.55009 Boehringer Ingelheim Investigational Site
Vitória
Czechia10 sites
1237.19.42001 Boehringer Ingelheim Investigational Site
Beroun
1237.19.42010 Boehringer Ingelheim Investigational Site
Český Krumlov
1237.19.42004 Boehringer Ingelheim Investigational Site
Hradec Králové
1237.19.42002 Boehringer Ingelheim Investigational Site
Jindřichův Hradec
1237.19.42006 Boehringer Ingelheim Investigational Site
Krnov
1237.19.42007 Boehringer Ingelheim Investigational Site
Liberec
1237.19.42003 Boehringer Ingelheim Investigational Site
Mělník
1237.19.42005 Boehringer Ingelheim Investigational Site
Prague
1237.19.42008 Boehringer Ingelheim Investigational Site
Prague
1237.19.42009 Boehringer Ingelheim Investigational Site
Varnsdorf
Portugal10 sites
1237.19.35010 Boehringer Ingelheim Investigational Site
Almada
1237.19.35005 Boehringer Ingelheim Investigational Site
Amadora
1237.19.35008 Boehringer Ingelheim Investigational Site
Aveiro
1237.19.35009 Boehringer Ingelheim Investigational Site
Braga
1237.19.35001 Boehringer Ingelheim Investigational Site
Coimbra
1237.19.35012 Boehringer Ingelheim Investigational Site
Guimarães
1237.19.35002 Boehringer Ingelheim Investigational Site
Lisbon
1237.19.35004 Boehringer Ingelheim Investigational Site
Lisbon
1237.19.35003 Boehringer Ingelheim Investigational Site
Porto
1237.19.35006 Boehringer Ingelheim Investigational Site
Vila Nova de Gaia
South Africa10 sites
1237.19.27001 Boehringer Ingelheim Investigational Site
Cape Town
1237.19.27002 Boehringer Ingelheim Investigational Site
Cape Town
1237.19.27003 Boehringer Ingelheim Investigational Site
Cape Town
1237.19.27007 Boehringer Ingelheim Investigational Site
Cape Town
1237.19.27009 Boehringer Ingelheim Investigational Site
Cape Town
1237.19.27006 Boehringer Ingelheim Investigational Site
eManzimtoti
1237.19.27011 Boehringer Ingelheim Investigational Site
Morningside, Sandton
1237.19.27010 Boehringer Ingelheim Investigational Site
Parow
1237.19.27004 Boehringer Ingelheim Investigational Site
Pretoria
1237.19.27008 Boehringer Ingelheim Investigational Site
Pretoria
South Korea10 sites
1237.19.82004 Boehringer Ingelheim Investigational Site
Bucheon-si
1237.19.82009 Boehringer Ingelheim Investigational Site
Goyang
1237.19.82006 Boehringer Ingelheim Investigational Site
Gwangju
1237.19.82001 Boehringer Ingelheim Investigational Site
Seoul
1237.19.82002 Boehringer Ingelheim Investigational Site
Seoul
1237.19.82005 Boehringer Ingelheim Investigational Site
Seoul
1237.19.82007 Boehringer Ingelheim Investigational Site
Seoul
1237.19.82008 Boehringer Ingelheim Investigational Site
Seoul
1237.19.82010 Boehringer Ingelheim Investigational Site
Seoul
1237.19.82003 Boehringer Ingelheim Investigational Site
Wŏnju
Taiwan10 sites
1237.19.88010 Boehringer Ingelheim Investigational Site
Kaohsiung City
1237.19.88011 Boehringer Ingelheim Investigational Site
Kaohsiung City
1237.19.88012 Boehringer Ingelheim Investigational Site
Kaohsiung City
1237.19.88004 Boehringer Ingelheim Investigational Site
New Taipei City
1237.19.88009 Boehringer Ingelheim Investigational Site
New Taipei City
1237.19.88001 Boehringer Ingelheim Investigational Site
Taipei
1237.19.88005 Boehringer Ingelheim Investigational Site
Taipei
1237.19.88007 Boehringer Ingelheim Investigational Site
Taipei
1237.19.88008 Boehringer Ingelheim Investigational Site
Taipei
1237.19.88013 Boehringer Ingelheim Investigational Site
Taipei
Ukraine10 sites
1237.19.38009 Boehringer Ingelheim Investigational Site
Ivano-Frankivsk
1237.19.38001 Boehringer Ingelheim Investigational Site
Kharkiv
1237.19.38005 Boehringer Ingelheim Investigational Site
Kiev
1237.19.38007 Boehringer Ingelheim Investigational Site
Kiev
1237.19.38002 Boehringer Ingelheim Investigational Site
Kyiv
1237.19.38003 Boehringer Ingelheim Investigational Site
Kyiv
1237.19.38004 Boehringer Ingelheim Investigational Site
Kyiv
1237.19.38006 Boehringer Ingelheim Investigational Site
Kyiv
1237.19.38010 Boehringer Ingelheim Investigational Site
Odesa
1237.19.38008 Boehringer Ingelheim Investigational Site
Vinnytsia
Bulgaria8 sites
1237.19.35905 Boehringer Ingelheim Investigational Site
Plovdiv
1237.19.35902 Boehringer Ingelheim Investigational Site
Rousse
1237.19.35903 Boehringer Ingelheim Investigational Site
Sofia
1237.19.35904 Boehringer Ingelheim Investigational Site
Sofia
1237.19.35906 Boehringer Ingelheim Investigational Site
Sofia
1237.19.35907 Boehringer Ingelheim Investigational Site
Troyan Municipality
1237.19.35901 Boehringer Ingelheim Investigational Site
Varna
1237.19.35908 Boehringer Ingelheim Investigational Site
Vidin
Denmark8 sites
1237.19.45004 Boehringer Ingelheim Investigational Site
Aalborg
1237.19.45007 Boehringer Ingelheim Investigational Site
Aarhus
1237.19.45006 Boehringer Ingelheim Investigational Site
Holstebro
1237.19.45002 Boehringer Ingelheim Investigational Site
Hvidovre
1237.19.45005 Boehringer Ingelheim Investigational Site
Kolding
1237.19.45001 Boehringer Ingelheim Investigational Site
Odense
1237.19.45008 Boehringer Ingelheim Investigational Site
Roskilde
1237.19.45003 Boehringer Ingelheim Investigational Site
Vaerløse
Greece8 sites
1237.19.30003 Boehringer Ingelheim Investigational Site
Athens
1237.19.30007 Boehringer Ingelheim Investigational Site
Athens
1237.19.30008 Boehringer Ingelheim Investigational Site
Athens
1237.19.30004 Boehringer Ingelheim Investigational Site
Heraklion
1237.19.30002 Boehringer Ingelheim Investigational Site
Nafplion
1237.19.30005 Boehringer Ingelheim Investigational Site
Serres
1237.19.30001 Boehringer Ingelheim Investigational Site
Thessaloniki
1237.19.30006 Boehringer Ingelheim Investigational Site
Thessaloniki
New Zealand8 sites
1237.19.64003 Boehringer Ingelheim Investigational Site
Auckland, New Zealand
1237.19.64002 Boehringer Ingelheim Investigational Site
Christchurch
1237.19.64004 Boehringer Ingelheim Investigational Site
Christchurch Central
1237.19.64007 Boehringer Ingelheim Investigational Site
Dunedin
1237.19.64008 Boehringer Ingelheim Investigational Site
Dunedin
1237.19.64001 Boehringer Ingelheim Investigational Site
Greenlane East Auckland NZ
1237.19.64005 Boehringer Ingelheim Investigational Site
Hamilton
1237.19.64009 Boehringer Ingelheim Investigational Site
Tauranga
Serbia8 sites
1237.19.38101 Boehringer Ingelheim Investigational Site
Belgrade
1237.19.38102 Boehringer Ingelheim Investigational Site
Belgrade
1237.19.38105 Boehringer Ingelheim Investigational Site
Belgrade
1237.19.38107 Boehringer Ingelheim Investigational Site
Belgrade
1237.19.38103 Boehringer Ingelheim Investigational Site
Kamenitz
1237.19.38104 Boehringer Ingelheim Investigational Site
Kragujevac
1237.19.38108 Boehringer Ingelheim Investigational Site
Niš
1237.19.38106 Boehringer Ingelheim Investigational Site
Sombor
Austria7 sites
1237.19.43006 Boehringer Ingelheim Investigational Site
Feldbach
1237.19.43004 Boehringer Ingelheim Investigational Site
Graz
1237.19.43003 Boehringer Ingelheim Investigational Site
Leoben
1237.19.43001 Boehringer Ingelheim Investigational Site
Linz
1237.19.70001 Boehringer Ingelheim Investigational Site
Ryazan
1237.19.43005 Boehringer Ingelheim Investigational Site
Salzburg
1237.19.43002 Boehringer Ingelheim Investigational Site
Vienna
Belgium7 sites
1237.19.32001 Boehringer Ingelheim Investigational Site
Brussels
1237.19.32007 Boehringer Ingelheim Investigational Site
Brussels
1237.19.32006 Boehringer Ingelheim Investigational Site
Gilly
1237.19.32004 Boehringer Ingelheim Investigational Site
Jambes
1237.19.32003 Boehringer Ingelheim Investigational Site
Lebbeke
1237.19.32002 Boehringer Ingelheim Investigational Site
Turnhout
1237.19.32005 Boehringer Ingelheim Investigational Site
Zichem
Norway7 sites
1237.19.47002 Boehringer Ingelheim Investigational Site
Arendal
1237.19.47008 Boehringer Ingelheim Investigational Site
Hamar
1237.19.47001 Boehringer Ingelheim Investigational Site
Hønefoss
1237.19.47006 Boehringer Ingelheim Investigational Site
Kløfta
1237.19.47007 Boehringer Ingelheim Investigational Site
Lierskogen
1237.19.47004 Boehringer Ingelheim Investigational Site
Oslo
1237.19.47005 Boehringer Ingelheim Investigational Site
Skedsmokorset
Philippines7 sites
1237.19.63007 Boehringer Ingelheim Investigational Site
Angeles City
1237.19.63001 Boehringer Ingelheim Investigational Site
Cebu City
1237.19.63003 Boehringer Ingelheim Investigational Site
Dasmariñas
1237.19.63008 Boehringer Ingelheim Investigational Site
Davao City
1237.19.63006 Boehringer Ingelheim Investigational Site
Iloilo City
1237.19.63005 Boehringer Ingelheim Investigational Site
Manila
1237.19.63002 Boehringer Ingelheim Investigational Site
Quezon City
Romania7 sites
1237.19.40007 Boehringer Ingelheim Investigational Site
Bragadiru
1237.19.40003 Boehringer Ingelheim Investigational Site
Bucharest
1237.19.40004 Boehringer Ingelheim Investigational Site
Bucharest
1237.19.40005 Boehringer Ingelheim Investigational Site
Bucharest
1237.19.40008 Boehringer Ingelheim Investigational Site
Bucharest
1237.19.40002 Boehringer Ingelheim Investigational Site
Constanța
1237.19.40006 Boehringer Ingelheim Investigational Site
Timișoara
Slovakia7 sites
1237.19.42101 Boehringer Ingelheim Investigational Site
Bratislava
1237.19.42104 Boehringer Ingelheim Investigational Site
Humenné
1237.19.42102 Boehringer Ingelheim Investigational Site
Košice
1237.19.42106 Boehringer Ingelheim Investigational Site
Martin
1237.19.42107 Boehringer Ingelheim Investigational Site
Poprad
1237.19.42103 Boehringer Ingelheim Investigational Site
Spišská Nová Ves
1237.19.42105 Boehringer Ingelheim Investigational Site
Vráble
Thailand7 sites
1237.19.66008 Boehringer Ingelheim Investigational Site
Dusit
1237.19.66005 Boehringer Ingelheim Investigational Site
Hat Yai
1237.19.66003 Boehringer Ingelheim Investigational Site
Maerim
1237.19.66001 Boehringer Ingelheim Investigational Site
Muang
1237.19.66002 Boehringer Ingelheim Investigational Site
Muang
1237.19.66007 Boehringer Ingelheim Investigational Site
Patumwan
1237.19.66004 Boehringer Ingelheim Investigational Site
Rajathevee
United Kingdom7 sites
1237.19.44008 Boehringer Ingelheim Investigational Site
Bedford
1237.19.44006 Boehringer Ingelheim Investigational Site
Birmingham
1237.19.44001 Boehringer Ingelheim Investigational Site
Bradford
1237.19.44002 Boehringer Ingelheim Investigational Site
Chertsey
1237.19.44004 Boehringer Ingelheim Investigational Site
Coventry
1237.19.44007 Boehringer Ingelheim Investigational Site
Doncaster
1237.19.44003 Boehringer Ingelheim Investigational Site
South Shields
Latvia6 sites
1237.19.37103 Boehringer Ingelheim Investigational Site
Daugavpils
1237.19.37101 Boehringer Ingelheim Investigational Site
Riga
1237.19.37105 Boehringer Ingelheim Investigational Site
Riga
1237.19.37106 Boehringer Ingelheim Investigational Site
Riga
1237.19.37104 Boehringer Ingelheim Investigational Site
Tukums
1237.19.37102 Boehringer Ingelheim Investigational Site
Valmiera
Mexico6 sites
1237.19.52006 Boehringer Ingelheim Investigational Site
Aguascalientes
1237.19.52007 Boehringer Ingelheim Investigational Site
Guadalajara
1237.19.52005 Boehringer Ingelheim Investigational Site
León
1237.19.52003 Boehringer Ingelheim Investigational Site
México
1237.19.52001 Boehringer Ingelheim Investigational Site
Monterrey
1237.19.52004 Boehringer Ingelheim Investigational Site
Tijuana
Sweden6 sites
1237.19.46002 Boehringer Ingelheim Investigational Site
Gothenburg
1237.19.46008 Boehringer Ingelheim Investigational Site
Härnösand
1237.19.46004 Boehringer Ingelheim Investigational Site
Höllviken
1237.19.46001 Boehringer Ingelheim Investigational Site
Lund
1237.19.46005 Boehringer Ingelheim Investigational Site
Rättvik
1237.19.46007 Boehringer Ingelheim Investigational Site
Stockholm
Colombia5 sites
1237.19.57002 Boehringer Ingelheim Investigational Site
Bogotá
1237.19.57004 Boehringer Ingelheim Investigational Site
Bogotá
1237.19.57005 Boehringer Ingelheim Investigational Site
Bogotá
1237.19.57003 Boehringer Ingelheim Investigational Site
Cali
1237.19.57006 Boehringer Ingelheim Investigational Site
Medellín
Guatemala5 sites
1237.19.50201 Boehringer Ingelheim Investigational Site
Guatemala City
1237.19.50202 Boehringer Ingelheim Investigational Site
Guatemala City
1237.19.50203 Boehringer Ingelheim Investigational Site
Guatemala City
1237.19.50204 Boehringer Ingelheim Investigational Site
Guatemala City
1237.19.50205 Boehringer Ingelheim Investigational Site
Guatemala City
Finland4 sites
1237.19.35804 Boehringer Ingelheim Investigational Site
Helsinki
1237.19.35805 Boehringer Ingelheim Investigational Site
Oulu
1237.19.35801 Boehringer Ingelheim Investigational Site
Turku
1237.19.35803 Boehringer Ingelheim Investigational Site
Turku
Lithuania4 sites
1237.19.37002 Boehringer Ingelheim Investigational Site
Kaunas
1237.19.37003 Boehringer Ingelheim Investigational Site
Klaipėda
1237.19.37004 Boehringer Ingelheim Investigational Site
Klaipėda
1237.19.37001 Boehringer Ingelheim Investigational Site
Vilnius
Malaysia4 sites
1237.19.60006 Boehringer Ingelheim Investigational Site
Kota Bharu
1237.19.60002 Boehringer Ingelheim Investigational Site
Kuala Lumpur
1237.19.60004 Boehringer Ingelheim Investigational Site
Kuala Terengganu
1237.19.60001 Boehringer Ingelheim Investigational Site
Kuching
Chile3 sites
1237.19.53004 Boehringer Ingelheim Investigational Site
Quillota
1237.19.53003 Boehringer Ingelheim Investigational Site
San Miguel
1237.19.53002 Boehringer Ingelheim Investigational Site
Santiago
Croatia3 sites
1237.19.38501 Boehringer Ingelheim Investigational Site
Rijeka
1237.19.38502 Boehringer Ingelheim Investigational Site
Zagreb
1237.19.38503 Boehringer Ingelheim Investigational Site
Zagreb
Hong Kong3 sites
1237.19.85201 Boehringer Ingelheim Investigational Site
Hong Kong
1237.19.85202 Boehringer Ingelheim Investigational Site
Hong Kong
1237.19.85203 Boehringer Ingelheim Investigational Site
Hong Kong
Slovenia3 sites
1237.19.38601 Boehringer Ingelheim Investigational Site
Golnik
1237.19.38603 Boehringer Ingelheim Investigational Site
Pohorje
1237.19.38602 Boehringer Ingelheim Investigational Site
Topolšica
Switzerland3 sites
1237.19.41004 Boehringer Ingelheim Investigational Site
Ascona
1237.19.41002 Boehringer Ingelheim Investigational Site
Bern
1237.19.41001 Boehringer Ingelheim Investigational Site
Liestal
Vietnam3 sites
1237.19.84003 Boehringer Ingelheim Investigational Site
Hà Nội
1237.19.84001 Boehringer Ingelheim Investigational Site
Ho Chi Minh City
1237.19.84002 Boehringer Ingelheim Investigational Site
Ho Chi Minh City
Ireland2 sites
1237.19.35301 Boehringer Ingelheim Investigational Site
Dublin
1237.19.35302 Boehringer Ingelheim Investigational Site
Wilton
Singapore2 sites
1237.19.65001 Boehringer Ingelheim Investigational Site
Singapore
1237.19.65002 Boehringer Ingelheim Investigational Site
Singapore
About this study
Official title: A Randomised, Double-blind, Active-controlled Parallel Group Study to Evaluate the Effect of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared With Tiotropium on Chronic Obstructive Pulmonary Disease (COPD) Exacerbation in Patients With Severe to Very Severe COPD. [DYNAGITO]
The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on moderate to severe COPD exacerbation in patients with severe to very severe COPD.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- olodaterol, tiotropium
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olodaterolDrug
fixed dose combination
tiotropiumDrug
fixed dose combination
tiotropiumDrug
| Study group | Role | What they receive |
|---|---|---|
| tiotropium + olodaterol high dose | Experimental | Once daily 2 puffs solution for inhalation Respimat Receives: Drug: olodaterol; Drug: tiotropium |
| tiotropium | Active comparator | Once daily 2 puffs solution for inhalation Respimat Receives: Drug: tiotropium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualised Rate of Moderate to Severe COPD Exacerbations During the Actual Treatment Period.
Annualised rate of moderate to severe COPD exacerbations during the actual treatment period was calculated per treatment per patient-year. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. Least Squares Means are actually exponentiated.
Measured: From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days
Secondary outcomes (4)
Number of Patients With at Least One Moderate to Severe COPD Exacerbation During the Actual Treatment Period.
Key secondary endpoint: Number of patients with at least one moderate to severe COPD exacerbation during the actual treatment period per treatment. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. The median was not estimated due to less than 50% of patients having an event. Hence the number of patients with at least one moderate to severe COPD exacerbation is presented.
Measured: From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days
Annualised Rate of Exacerbations Leading to Hospitalisation During the Actual Treatment Period.
Annualised rate of exacerbations leading to hospitalisation during the actual treatment period was calculated per treatment per patient-year. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication.
Measured: From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days
Number of Patients With at Least One COPD Exacerbation Leading to Hospitalisation During the Actual Treatment Period.
Number of patients with at least one COPD exacerbation leading to hospitalisation during the actual treatment period per treatment. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. The median was not estimated due to less than 50% of patients having an event. Hence the number of patients with at least one moderate to severe COPD exacerbation leading to hospitalisation is presented.
Measured: From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days
Number of Patients With All-cause Mortality Occurring During the Actual Treatment Period.
Number of patients with all-cause mortality occurring during the actual treatment period per treatment. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. The median was not estimated due to less than 50% of patients having an event. Hence the number of patients with all-cause mortality is presented.
Measured: From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study start13 Jan 2015
- Primary completion8 Mar 2017
- Study completion29 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 7,903 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296138
- Sponsor's protocol ID
- 1237.19
- Other IDs
- 2014-002275-28, 2014
- Status last verified
- May 2018
- First submitted
- 19 Nov 2014
- Last updated
- 4 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Singh D, Wedzicha JA, Siddiqui S, de la Hoz A, Xue W, Magnussen H, Miravitlles M, Chalmers JD, Calverley PMA. Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials. Respir Res. 2020 Sep 17;21(1):240. doi: 10.1186/s12931-020-01482-1.
PubMed 32943047Wedzicha JA, Buhl R, Singh D, Vogelmeier CF, de la Hoz A, Xue W, Anzueto A, Calverley PMA. Tiotropium/Olodaterol Decreases Exacerbation Rates Compared with Tiotropium in a Range of Patients with COPD: Pooled Analysis of the TONADO(R)/DYNAGITO(R) Trials. Adv Ther. 2020 Oct;37(10):4266-4279. doi: 10.1007/s12325-020-01438-3. Epub 2020 Aug 10.
PubMed 32776202Ferguson GT, Buhl R, Bothner U, Hoz A, Voss F, Anzueto A, Calverley PMA. Safety of tiotropium/olodaterol in chronic obstructive pulmonary disease: pooled analysis of three large, 52-week, randomized clinical trials. Respir Med. 2018 Oct;143:67-73. doi: 10.1016/j.rmed.2018.08.012. Epub 2018 Aug 28.
PubMed 30261995Calverley PMA, Anzueto AR, Carter K, Gronke L, Hallmann C, Jenkins C, Wedzicha J, Rabe KF. Tiotropium and olodaterol in the prevention of chronic obstructive pulmonary disease exacerbations (DYNAGITO): a double-blind, randomised, parallel-group, active-controlled trial. Lancet Respir Med. 2018 May;6(5):337-344. doi: 10.1016/S2213-2600(18)30102-4. Epub 2018 Apr 5.
PubMed 29605624
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Active-controlled Parallel Group Study to Evaluate the Effect of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared With Tiotropium on Chronic Obstructive Pulmonary Disease (COPD) Exacerbation in Patients With Severe to Very Severe COPD. [DYNAGITO]
- ClinicalTrials.gov ID
- NCT02296138
- Acronym / sponsor ID
- 1237.19
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,903 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2015 (actual)
- Primary completion
- 8 Mar 2017 (actual)
- Study completion
- 29 Mar 2017 (actual)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Posted 4 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on moderate to severe COPD exacerbation in patients with severe to very severe COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tiotropium + olodaterol high dose | Experimental | Drug: olodaterol, Drug: tiotropiumOnce daily 2 puffs solution for inhalation Respimat |
| tiotropium | Active comparator | Drug: tiotropiumOnce daily 2 puffs solution for inhalation Respimat |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients, 40 years of age or older.
- Diagnosis of COPD with a documented post-bronchodilator Forced expiratory volume in one second (FEV1)< 60% of predicted normal and a post-bronchodilator FEV1/ forced vital capacity (FVC) <70% at Visit 1
- Documented history of at least one moderate to severe COPD exacerbation in the previous 12 months requiring treatment with systemic corticosteroids and/or antibiotics and/or related hospitalization.
- Symptomatically stable as defined by: no evidence of COPD exacerbation requiring use of either antibiotics and/or steroids 4 weeks prior to visit 1 and no evidence of change in their usual COPD medication 4 weeks prior to visit 1.
- Current or ex-smokers with a smoking history of more than 10 pack years.
Key exclusion criteria (20 listed)
- Significant disease other than COPD.
- Clinically relevant abnormal baseline haematology, blood chemistry or creatinine > x2 ULN will be excluded regardless of clinical condition. ( A repeat laboratory evaluation can be conducted if deemed necessary by the investigator.)
- Current documented diagnosis of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma
- A diagnosis of thyrotoxicosis
- A history of myocardial infarction within 6 months of screening visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| olodaterolfixed dose combination | Drug | tiotropium + olodaterol high dose |
| tiotropiumfixed dose combination | Drug | tiotropium + olodaterol high dose |
| tiotropium | Drug | tiotropium |
Primary outcome
Annualised Rate of Moderate to Severe COPD Exacerbations During the Actual Treatment Period.
Time frame: From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days
Annualised rate of moderate to severe COPD exacerbations during the actual treatment period was calculated per treatment per patient-year. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. Least Squares Means are actually exponentiated.
4 secondary outcomes
Number of Patients With at Least One Moderate to Severe COPD Exacerbation During the Actual Treatment Period.
Time frame: From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days
Annualised Rate of Exacerbations Leading to Hospitalisation During the Actual Treatment Period.
Time frame: From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days
Number of Patients With at Least One COPD Exacerbation Leading to Hospitalisation During the Actual Treatment Period.
Time frame: From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days
Number of Patients With All-cause Mortality Occurring During the Actual Treatment Period.
Time frame: From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32943047Singh D, Wedzicha JA, Siddiqui S, de la Hoz A, Xue W, Magnussen H, Miravitlles M, Chalmers JD, Calverley PMA. Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials. Respir Res. 2020 Sep 17;21(1):240. doi: 10.1186/s12931-020-01482-1.
- Derived from this study: PubMed 32776202Wedzicha JA, Buhl R, Singh D, Vogelmeier CF, de la Hoz A, Xue W, Anzueto A, Calverley PMA. Tiotropium/Olodaterol Decreases Exacerbation Rates Compared with Tiotropium in a Range of Patients with COPD: Pooled Analysis of the TONADO(R)/DYNAGITO(R) Trials. Adv Ther. 2020 Oct;37(10):4266-4279. doi: 10.1007/s12325-020-01438-3. Epub 2020 Aug 10.
- Derived from this study: PubMed 30261995Ferguson GT, Buhl R, Bothner U, Hoz A, Voss F, Anzueto A, Calverley PMA. Safety of tiotropium/olodaterol in chronic obstructive pulmonary disease: pooled analysis of three large, 52-week, randomized clinical trials. Respir Med. 2018 Oct;143:67-73. doi: 10.1016/j.rmed.2018.08.012. Epub 2018 Aug 28.
- Derived from this study: PubMed 29605624Calverley PMA, Anzueto AR, Carter K, Gronke L, Hallmann C, Jenkins C, Wedzicha J, Rabe KF. Tiotropium and olodaterol in the prevention of chronic obstructive pulmonary disease exacerbations (DYNAGITO): a double-blind, randomised, parallel-group, active-controlled trial. Lancet Respir Med. 2018 May;6(5):337-344. doi: 10.1016/S2213-2600(18)30102-4. Epub 2018 Apr 5.
Related trials for Pulmonary Disease, Chronic Obstructive
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
818 sites in 51 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing olodaterol and tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 818 sites in 51 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 818 sites in Japan, United States, Germany, Russia, Canada and 46 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annualised Rate of Moderate to Severe COPD Exacerbations During the Actual Treatment Period. (time frame: From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02296138, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2018.