Pulmonary Disease, Chronic ObstructivePhase 3NCT00387088

Tiotropium / Respimat One Year Study in COPD.

A Phase 3 study testing Respimat and Tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 334 sites in 31 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The objective of the study is to evaluate the long-term (one year) efficacy and safety of tiotropium delivered by the Respimat inhaler in patients with COPD. Specifically, the study will examine the effect of treatment on COPD exacerbations. 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?: Respimat and Tiotropium
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3,991 participants
Where: 334 sitesin 31 countries
Study dates: Sep 2006to Jan 2009
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
At least 40 years old
Smoker or ex-smoker
Smoking history > 10 pack-years
Forced Expiratory Volume in 1 Second (FEV1) < 60% predicted

Who cannot join

Recent history of myocardial infarction, life-threatening cardiac arrhythmia or hospitalisation for cardiac failure
History of asthma or allergic conditions.
Malignancy requiring treatment within past 5 years
Life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
Known active tuberculosis
Known hypersensitivity to anticholinergic drugs.

Trial locations and contacts

334 sites in 31 countries.

Country

City, postcode or hospital

334 sites in 31 countries

United States57 sites

205.372.01046 Boehringer Ingelheim Investigational Site
Albuquerque, New Mexico
205.372.01048 Boehringer Ingelheim Investigational Site
Berkeley, California
205.372.01015 Boehringer Ingelheim Investigational Site
Biddeford, Maine
205.372.01012 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
205.372.01020 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
205.372.01066 Boehringer Ingelheim Investigational Site
Boulder, Colorado
205.372.01004 Boehringer Ingelheim Investigational Site
Brandon, Florida
205.372.01045 Boehringer Ingelheim Investigational Site
Calhoun, Georgia
205.372.01026 Boehringer Ingelheim Investigational Site
Chapel Hill, North Carolina
205.372.01019 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina
205.372.01021 Boehringer Ingelheim Investigational Site
Chesterfield, Missouri
205.372.01017 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
205.372.01041 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
205.372.01044 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
205.372.01060 Boehringer Ingelheim Investigational Site
Clearwater, Florida
205.372.01067 Boehringer Ingelheim Investigational Site
Columbia, Maryland
205.372.01039 Boehringer Ingelheim Investigational Site
Dallas, Texas
205.372.01050 Boehringer Ingelheim Investigational Site
Dallas, Texas
205.372.01022 Boehringer Ingelheim Investigational Site
Danville, Virginia
205.372.01013 Boehringer Ingelheim Investigational Site
Detroit, Michigan
205.372.01061 Boehringer Ingelheim Investigational Site
Dubuque, Iowa
205.372.01027 Boehringer Ingelheim Investigational Site
Elizabeth City, North Carolina
205.372.01063 Boehringer Ingelheim Investigational Site
Eugene, Oregon
205.372.01005 Boehringer Ingelheim Investigational Site
Fort Worth, Texas
205.372.01037 Boehringer Ingelheim Investigational Site
Huntington Park, California
205.372.01018 Boehringer Ingelheim Investigational Site
Killeen, Texas
205.372.01058 Boehringer Ingelheim Investigational Site
Long Beach, California
205.372.01059 Boehringer Ingelheim Investigational Site
Long Beach, California
205.372.01007 Boehringer Ingelheim Investigational Site
Los Angeles, California
205.372.01034 Boehringer Ingelheim Investigational Site
Los Angeles, California
205.372.01065 Boehringer Ingelheim Investigational Site
Lynchburg, Virginia
205.372.01069 Boehringer Ingelheim Investigational Site
Miami Beach, Florida
205.372.01024 Boehringer Ingelheim Investigational Site
Mineola, New York
205.372.01003 Boehringer Ingelheim Investigational Site
Minneapolis, Minnesota
205.372.01062 Boehringer Ingelheim Investigational Site
Mobile, Alabama
205.372.01040 Boehringer Ingelheim Investigational Site
New Braunfels, Texas
205.372.01043 Boehringer Ingelheim Investigational Site
Normal, Illinois
205.372.01008 Boehringer Ingelheim Investigational Site
Norwalk, Connecticut
205.372.01001 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma
205.372.01036 Boehringer Ingelheim Investigational Site
Omaha, Nebraska
205.372.01068 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
205.372.01038 Boehringer Ingelheim Investigational Site
Raleigh, North Carolina
205.372.01028 Boehringer Ingelheim Investigational Site
Rancho Mirage, California
205.372.01055 Boehringer Ingelheim Investigational Site
Richmond, Virginia
205.372.01029 Boehringer Ingelheim Investigational Site
Rochester, New York
205.372.01006 Boehringer Ingelheim Investigational Site
Rockville, Maryland
205.372.01052 Boehringer Ingelheim Investigational Site
San Antonio, Texas
205.372.01011 Boehringer Ingelheim Investigational Site
San Diego, California
205.372.01049 Boehringer Ingelheim Investigational Site
Shreveport, Louisiana
205.372.01014 Boehringer Ingelheim Investigational Site
St Louis, Missouri
205.372.01056 Boehringer Ingelheim Investigational Site
Swathmore, Pennsylvania
205.372.01030 Boehringer Ingelheim Investigational Site
Syracuse, New York
205.372.01064 Boehringer Ingelheim Investigational Site
Tacoma, Washington
205.372.01023 Boehringer Ingelheim Investigational Site
West Palm Beach, Florida
205.372.01035 Boehringer Ingelheim Investigational Site
Wichita, Kansas
205.372.01031 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina
205.372.01053 Boehringer Ingelheim Investigational Site
Winter Park, Florida

Other trials in United States

France28 sites

205.372.3318A Clinique du Parc
Castelnau-le-Lez
205.372.3318B Clinique du Parc
Castelnau-le-Lez
205.372.3304A Cabinet Médical
Chamalières
205.372.3301A Hôpital Gabriel Montpied
Clermont-Ferrand
205.372.3310A Centre Hospitalier
Denain
205.372.3314A Cabinet Médical
Grasse
205.372.3306A Hôpital Ambroise Paré
Marseille
205.372.3303A Hôpital Notre Dame de Bon Secours
Metz
205.372.3303B Hôpital Notre Dame de Bon Secours
Metz
205.372.3312A Cabinet Médical
Montigny-lès-Metz
205.372.3312B Cabinet Médical
Montigny-lès-Metz
205.372.3302A Centre Médical Erdre Saint Augustin
Nantes
205.372.3305A Cabinet Médical
Nice
205.372.3305B Cabinet Médical
Nice
205.372.3315A Hôpital Caremeau
Nîmes
205.372.3315B Hôpital Caremeau
Nîmes
205.372.3317A Cabinet de Pneumologie
Nîmes
205.372.3320A Polyclinique Les Fleurs
Ollioules
205.372.3320B Polyclinique Les Fleurs
Ollioules
205.372.3316A Clinique les Bleuets
Reims
205.372.3316B Clinique les Bleuets
Reims
205.372.3321A Centre Hospitalier
Saint-Gaudens
205.372.3321C Centre Hospitalier
Saint-Gaudens
205.372.3319A Institut Arnault Tzanck
Saint-Laurent-du-Var
205.372.3325A Cabinet Médical
Six Four Les Plages
205.372.3324A Cabinet Médical
Toulon
205.372.3309A Cabinet médical
Toulouse
205.372.3309B Cabinet médical
Toulouse

Other trials in France

United Kingdom25 sites

205.372.44027 Boehringer Ingelheim Investigational Site
Aston Clinton, Aylesbury
205.372.44022 Boehringer Ingelheim Investigational Site
Carmarthen
205.372.44002 Boehringer Ingelheim Investigational Site
Chertsey
205.372.44023 Boehringer Ingelheim Investigational Site
Chesterfield
205.372.44014 Boehringer Ingelheim Investigational Site
Darlington
205.372.44009 Boehringer Ingelheim Investigational Site
East Horsley
205.372.44011 Boehringer Ingelheim Investigational Site
Fowey
205.372.44003 Boehringer Ingelheim Investigational Site
Frome
205.372.44026 Boehringer Ingelheim Investigational Site
Greenisland
205.372.44013 Boehringer Ingelheim Investigational Site
Heywood
205.372.44016 Boehringer Ingelheim Investigational Site
Isleworth
205.372.44020 Boehringer Ingelheim Investigational Site
Kirkby in Ashfield
205.372.44024 Boehringer Ingelheim Investigational Site
Mortimer
205.372.44001 Boehringer Ingelheim Investigational Site
Nottingham
205.372.44018 Boehringer Ingelheim Investigational Site
Penzance
205.372.44021 Boehringer Ingelheim Investigational Site
Plymouth
205.372.44005 Boehringer Ingelheim Investigational Site
Saint Just, Penzance
205.372.44007 Boehringer Ingelheim Investigational Site
Sheffield
205.372.44010 Boehringer Ingelheim Investigational Site
Sneinton, Nottingham
205.372.44015 Boehringer Ingelheim Investigational Site
St Austell
205.372.44006 Boehringer Ingelheim Investigational Site
Sunderland
205.372.44008 Boehringer Ingelheim Investigational Site
Wellingborough
205.372.44012 Boehringer Ingelheim Investigational Site
Westbury on Trym
205.372.44028 Boehringer Ingelheim Investigational Site
Windsor
205.372.44019 Boehringer Ingelheim Investigational Site
Woking

Other trials in United Kingdom

Canada19 sites

205.372.11007 Heritage Medical Research Building
Calgary, Alberta
205.372.11013 Calgary West Medical Centre
Calgary, Alberta
205.372.11010 Dr. Kay Ho
Chilliwack, British Columbia
205.372.11011 Hermitage Medicentre
Edmonton, Alberta
205.372.11017 Boehringer Ingelheim Investigational Site
Edmonton, Alberta
205.372.11012 West Lincoln Memorial Hospital
Grimsby, Ontario
205.372.11006 Clinique de médecine familiale de La Malbaie
La Malbaie, Quebec
205.372.11014 Dr. Robert Luton
London, Ontario
205.372.11001 Niagara Clinical Research
Niagara Falls, Ontario
205.372.11019 Allergy and Asthma Research Centre
Ottawa, Ontario
205.372.11005 Professional Corp. Respirology
Saint John, New Brunswick
205.372.11003 London Road Diagnostic Clinic and Medical Centre
Sarnia, Ontario
205.372.11016 London Road Diagnostic Clinic and Medical Centre
Sarnia, Ontario
205.372.11004 Mount Royal Family Physicians
Saskatoon, Saskatchewan
205.372.11015 Dr. Arun Nayar
Saskatoon, Saskatchewan
205.372.11002 Centenary Respiratory Research Associates
Scarborough Village, Ontario
205.372.11009 White Hills Medical Clinic
St. John's, Newfoundland and Labrador
205.372.11018 Pacific Lung Health Centre
Vancouver, British Columbia
205.372.11020 Wetaskiwin Lung Laboratory
Wetaskiwin, Alberta

Other trials in Canada

India17 sites

205.372.91005 Boehringer Ingelheim Investigational Site
Andhra Pradesh
205.372.91016 Boehringer Ingelheim Investigational Site
Andhra Pradesh
205.372.91003 Boehringer Ingelheim Investigational Site
Bangalore
205.372.91006 Boehringer Ingelheim Investigational Site
Bangalore
205.372.91017 Boehringer Ingelheim Investigational Site
Calicut,Kerala
205.372.91007 Boehringer Ingelheim Investigational Site
Chennai
205.372.91010 Boehringer Ingelheim Investigational Site
Chennai
205.372.91002 Boehringer Ingelheim Investigational Site
Coimbatore
205.372.91009 Boehringer Ingelheim Investigational Site
Gujarat
205.372.91011 Boehringer Ingelheim Investigational Site
indore,MP
205.372.91012 Boehringer Ingelheim Investigational Site
Maharashtra
205.372.91004 Boehringer Ingelheim Investigational Site
Mumbai
205.372.91008 Boehringer Ingelheim Investigational Site
Mumbai
205.372.91015 Boehringer Ingelheim Investigational Site
New Delhi
205.372.91014 Boehringer Ingelheim Investigational Site
Punjab
205.372.91013 Boehringer Ingelheim Investigational Site
Tamil Nadu
205.372.91001 Boehringer Ingelheim Investigational Site
Uttar Pradesh

Other trials in India

Germany16 sites

205.372.49002 Boehringer Ingelheim Investigational Site
Berlin
205.372.49004 Boehringer Ingelheim Investigational Site
Berlin
205.372.49013 Boehringer Ingelheim Investigational Site
Berlin
205.372.49007 Boehringer Ingelheim Investigational Site
Bonn
205.372.49008 Boehringer Ingelheim Investigational Site
Bruchsal
205.372.49011 Boehringer Ingelheim Investigational Site
Frankfurt am Main
205.372.49012 Boehringer Ingelheim Investigational Site
Gelnhausen
205.372.49006 Boehringer Ingelheim Investigational Site
Gütersloh
205.372.49014 Boehringer Ingelheim Investigational Site
Hanover
205.372.49005 Boehringer Ingelheim Investigational Site
Kassel
205.372.49009 Boehringer Ingelheim Investigational Site
Minden
205.372.49010 Boehringer Ingelheim Investigational Site
München
205.372.49016 Boehringer Ingelheim Investigational Site
Weinheim
205.372.49015 Boehringer Ingelheim Investigational Site
Weyhe
205.372.49001 Boehringer Ingelheim Investigational Site
Wiesloch
205.372.49003 Boehringer Ingelheim Investigational Site
Witten

Other trials in Germany

Greece15 sites

205.372.30001 Boehringer Ingelheim Investigational Site
Athens
205.372.30002 Boehringer Ingelheim Investigational Site
Athens
205.372.30003 Boehringer Ingelheim Investigational Site
Athens
205.372.30013 Boehringer Ingelheim Investigational Site
Athens
205.372.30015 Boehringer Ingelheim Investigational Site
Athens
205.372.30011 Boehringer Ingelheim Investigational Site
Corinth
205.372.30009 Boehringer Ingelheim Investigational Site
Heraklion-Crete
205.372.30007 Boehringer Ingelheim Investigational Site
Kalamaria
205.372.30005 Boehringer Ingelheim Investigational Site
Kavala
205.372.30004 Boehringer Ingelheim Investigational Site
Komotini
205.372.30019 Boehringer Ingelheim Investigational Site
Nafplion
205.372.30008 Boehringer Ingelheim Investigational Site
Serres
205.372.30014 Boehringer Ingelheim Investigational Site
Thebes
205.372.30006 Boehringer Ingelheim Investigational Site
Thessaloniki
205.372.30017 Boehringer Ingelheim Investigational Site
Thessaloniki

Other trials in Greece

Mexico14 sites

205.372.52018 Hospital Universitario de Chihuahua
Chihuahua City
205.372.52017 Instituto Nacional de Enfermedades Respiratorias (INER)
Col. Seccion XVI
205.372.52013 Sanatorio Henri Dunant
Cuernavaca, Mor. México
205.372.52005 Hospital Civil Nuevo de Guadalajara
Guadalajara
205.372.52009 Hospital Civil Antiguo
Guadalajara Jal.
205.372.52001 Hospital General del Estado de Sonora
Hermosillo, Sonora
205.372.52014 Hospital Angeles de las Lomas
Huixquilucan Edo.Mex.
205.372.52004 Clínica de Mérida
Merida Yuc.
205.372.52010 Hospital General Agustin O´Haran
Mérida Yucatán
205.372.52016 Hospital General de Mexicali
Mexicali Baja California Norte
205.372.52002 Unidad de Investigación clínica en Medicina
Monterrey, Nuevo León
205.372.52006 Hospital Universitario
Monterrey, Nuevo León
205.372.52012 Hospital de Nuestra Señora de la Salud
San Luis Potosí City
205.372.52003 Hospital "Angel Leaño"
Zapopan, Jal.

Other trials in Mexico

China12 sites

205.372.86002 Boehringer Ingelheim Investigational Site
Beijing
205.372.86003 Boehringer Ingelheim Investigational Site
Beijing
205.372.86004 Boehringer Ingelheim Investigational Site
Beijing
205.372.86009 Boehringer Ingelheim Investigational Site
Chengdu, Sichuan Province
205.372.86008 Boehringer Ingelheim Investigational Site
Chongqing
205.372.86001 Boehringer Ingelheim Investigational Site
Guangzhou
205.372.86010 Boehringer Ingelheim Investigational Site
Shanghai
205.372.86011 Boehringer Ingelheim Investigational Site
Shanghai
205.372.86012 Boehringer Ingelheim Investigational Site
Shanghai
205.372.86005 Boehringer Ingelheim Investigational Site
Shenyang
205.372.86006 Boehringer Ingelheim Investigational Site
Shenyang
205.372.86007 Boehringer Ingelheim Investigational Site
Wuhan

Other trials in China

Italy12 sites

205.372.39007 Boehringer Ingelheim Investigational Site
Bussolengo (vr)
205.372.39012 Boehringer Ingelheim Investigational Site
Ferrara
205.372.39003 Boehringer Ingelheim Investigational Site
Genova
205.372.39004 Boehringer Ingelheim Investigational Site
Genova
205.372.39005 Boehringer Ingelheim Investigational Site
Milan
205.372.39008 Boehringer Ingelheim Investigational Site
Modena
205.372.39009 Boehringer Ingelheim Investigational Site
Orbassano (to)
205.372.39001 Boehringer Ingelheim Investigational Site
Pisa
205.372.39010 Boehringer Ingelheim Investigational Site
Pordenone
205.372.39002 Boehringer Ingelheim Investigational Site
Prato (fi)
205.372.39011 Boehringer Ingelheim Investigational Site
Roma
205.372.39006 Boehringer Ingelheim Investigational Site
Trieste

Other trials in Italy

Netherlands11 sites

205.372.31009 Boehringer Ingelheim Investigational Site
Amsterdam
205.372.31006 Boehringer Ingelheim Investigational Site
Drachten
205.372.31001 Boehringer Ingelheim Investigational Site
Groningen
205.372.31011 Boehringer Ingelheim Investigational Site
Hoofddorp
205.372.31007 Boehringer Ingelheim Investigational Site
Leeuwarden
205.372.31004 Boehringer Ingelheim Investigational Site
Roosendaal
205.372.31003 Boehringer Ingelheim Investigational Site
Sneek
205.372.31012 Boehringer Ingelheim Investigational Site
Utrecht
205.372.31002 Boehringer Ingelheim Investigational Site
Voorburg
205.372.31008 Boehringer Ingelheim Investigational Site
Weerselo
205.372.31005 Boehringer Ingelheim Investigational Site
Winschoten

Other trials in Netherlands

Australia10 sites

205.372.61010 Ecru
Box Hill, Victoria
205.372.61009 Thoracic & General Physician
Cairns, Queensland
205.372.61008 Geelong Clinical Research Centre
Geelong, Victoria
205.372.61002 Woolcock Institute of Medical Research
Glebe, New South Wales
205.372.61001 Emeritus Research
Malvern, Victoria
205.372.61003 Sir Charles Gairdner Hospital
Nedlands, Western Australia
205.372.61006 The Investigator Clinic
Port Lincoln, South Australia
205.372.61005 Redcliffe Hospital
Redcliffe, Queensland
205.372.61007 The Burnside War Memorial Hospital
Toorak Gardens, South Australia
205.372.61004 Boehringer Ingelheim Investigational Site
Woodville, South Australia

Other trials in Australia

South Korea10 sites

205.372.82010 Boehringer Ingelheim Investigational Site
Anyang
205.372.82005 Boehringer Ingelheim Investigational Site
Daegu
205.372.82009 Boehringer Ingelheim Investigational Site
Daejoen
205.372.82003 Boehringer Ingelheim Investigational Site
Incheon
205.372.82008 Boehringer Ingelheim Investigational Site
Jeonbuk
205.372.82007 Boehringer Ingelheim Investigational Site
Kwangju
205.372.82002 Boehringer Ingelheim Investigational Site
Pusan
205.372.82001 Boehringer Ingelheim Investigational Site
Seoul
205.372.82004 Boehringer Ingelheim Investigational Site
Seoul
205.372.82006 Boehringer Ingelheim Investigational Site
Seoul

Other trials in South Korea

Turkey (Türkiye)10 sites

205.372.90006 Gazi Universitesi Tip Fakultesi Gogus Hastaliklari A.B.D.
Ankara
205.372.90007 Atatürk Gög. Hastaliklari ve Cerrahisi Egitim Hastanesi
Ankara
205.372.90003 Uludag Universitesi Tip Fakultesi Gogus Hastaliklari
Bursa
205.372.90009 Trakya Universitesi Tip Fakultesi Gogus Hastaliklari A.B.D.
Edirne
205.372.90004 Dr. Lütfi Kirdar Egitim ve Arastirma Hastanesi
Istanbul
205.372.90005 Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul
205.372.90001 Izmir Tepecik Gogus Hastaliklari ve Gogus Cerrahisi Hast.
Izmir
205.372.90008 Erciyes Universitesi Tip Fakultesi
Kayseri
205.372.90010 Selcuk Universitesi Tip Fakultesi
Konya
205.372.90002 19 Mayis Universitesi Tip Fakultesi Gogus Hastaliklari A.B.D
Samsun

Other trials in Turkey (Türkiye)

Taiwan9 sites

205.372.88607 Kaohsiung Medical University Hospital
Kaohsiung City
205.372.88606 National Cheng Kung University Hospital
Tainan
205.372.88601 National Taiwan University Hospital
Taipei
205.372.88602 Taipei Veterans General Hospital
Taipei
205.372.88603 Mackay Memorial Hospital
Taipei
205.372.88604 Tri-Service General Hospital
Taipei
205.372.88608 Boehringer Ingelheim Investigational Site
Taipei
205.372.88609 Boehringer Ingelheim Investigational Site
Taipei
205.372.88605 Chang Gung Memorial Hosp-Linkou
Taoyuan

Other trials in Taiwan

South Africa8 sites

205.372.27002 Boehringer Ingelheim Investigational Site
Bellville
205.372.27001 Boehringer Ingelheim Investigational Site
Cape Town
205.372.27004 Boehringer Ingelheim Investigational Site
Cape Town
205.372.27008 Boehringer Ingelheim Investigational Site
Cape Town
205.372.27006 Boehringer Ingelheim Investigational Site
Centurion
205.372.27003 Boehringer Ingelheim Investigational Site
Durban
205.372.27005 Boehringer Ingelheim Investigational Site
Pretoria
205.372.27007 Boehringer Ingelheim Investigational Site
Somerset West

Other trials in South Africa

Malaysia7 sites

205.372.60003 Boehringer Ingelheim Investigational Site
George Town
205.372.60007 Boehringer Ingelheim Investigational Site
Johor Bahru
205.372.60004 Boehringer Ingelheim Investigational Site
Kelantan Darul Naim
205.372.60005 Boehringer Ingelheim Investigational Site
Kuala Lumpur
205.372.60006 Boehringer Ingelheim Investigational Site
Kuala Lumpur
205.372.60001 Boehringer Ingelheim Investigational Site
Kuala Selangor
205.372.60002 Boehringer Ingelheim Investigational Site
Kuching, Sarawak

Other trials in Malaysia

Brazil6 sites

205.372.55012 Universidade Federal de Santa Catarina
Florianópolis
205.372.55009 Hospital das Clínicas de Goiânia
Goiânia
205.372.55005 Hospital Geral Otávio de Freitas
Recife
205.372.55001 INCOR e Hospital das Clínicas da Universidade de São Paulo
São Paulo - SP
205.372.55010 Unidade de Coracao e Pulmao do Dto. de Medicina
São Paulo - SP
205.372.55011 CEDOES - Diagnóstico e Pesquisa
Vitória

Other trials in Brazil

Denmark6 sites

205.372.45004 Boehringer Ingelheim Investigational Site
Aarhus C
205.372.45005 Boehringer Ingelheim Investigational Site
Horsens
205.372.45002 Boehringer Ingelheim Investigational Site
Hvidovre
205.372.45001 Boehringer Ingelheim Investigational Site
København NV
205.372.45003 Boehringer Ingelheim Investigational Site
Odense C
205.372.45006 Boehringer Ingelheim Investigational Site
Silkeborg

Other trials in Denmark

Hungary6 sites

205.372.36001 Boehringer Ingelheim Investigational Site
Budapest
205.372.36002 Boehringer Ingelheim Investigational Site
Debrecen
205.372.36004 Boehringer Ingelheim Investigational Site
Deszk
205.372.36005 Boehringer Ingelheim Investigational Site
Érd
205.372.36006 Boehringer Ingelheim Investigational Site
Mosonmagyaróvár
205.372.36007 Boehringer Ingelheim Investigational Site
Sopron

Other trials in Hungary

Portugal5 sites

205.372.35102 Hospital Fernando Fonseca
Amadora
205.372.35101 Hospital Pulido Valente
Lisbon
205.372.35104 Hospital de Santa Marta
Lisbon
205.372.35103 Hospital de São João
Porto
205.372.35105 Centro Hospitalar do Alto Minho, Estrada de Santa Luzia
Viana do Castelo

Other trials in Portugal

Spain5 sites

205.372.34005 Hospital San Pedro de Alcántara
Cáceres
205.372.34004 Hospital Gregorio Marañón
Madrid
205.372.34006 Hospital 12 de octubre
Madrid
205.372.34001 Hospital Mutua Terrassa
Terrassa (Barcelona)
205.372.34002 Hospital Universitario Dr. Peset
Valencia

Other trials in Spain

Sweden5 sites

205.372.46001 Björknäs Vårdcentral
Boden
205.372.46004 Näsets läkargrupp
Höllviken
205.372.46005 Lungmedicinska kliniken
Linköping
205.372.46006 Lungmedicinska Kliniken
Stockholm
205.372.46002 Alnö Vårdcentral
Sundsvall

Other trials in Sweden

Finland4 sites

205.372.35804 Boehringer Ingelheim Investigational Site
Helsinki
205.372.35802 Boehringer Ingelheim Investigational Site
Jyväskylä
205.372.35803 Boehringer Ingelheim Investigational Site
Lahti
205.372.35801 Boehringer Ingelheim Investigational Site
Tampere

Other trials in Finland

Lithuania3 sites

205.372.37001 Boehringer Ingelheim Investigational Site
Kaunas
205.372.37003 Boehringer Ingelheim Investigational Site
Kaunas
205.372.37002 Boehringer Ingelheim Investigational Site
Vilnius

Other trials in Lithuania

Norway3 sites

205.372.47002 Boehringer Ingelheim Investigational Site
Ålesund
205.372.47001 Boehringer Ingelheim Investigational Site
Sandvika
205.372.47003 Boehringer Ingelheim Investigational Site
Trondheim

Other trials in Norway

Singapore3 sites

205.372.65001 Boehringer Ingelheim Investigational Site
Singapore
205.372.65003 Boehringer Ingelheim Investigational Site
Singapore
205.372.65005 Boehringer Ingelheim Investigational Site
Singapore

Other trials in Singapore

Switzerland3 sites

205.372.41002 Boehringer Ingelheim Investigational Site
Lugano
205.372.41003 Boehringer Ingelheim Investigational Site
Montana
205.372.41001 Boehringer Ingelheim Investigational Site
Zurich

Other trials in Switzerland

Hong Kong2 sites

205.372.85203 Boehringer Ingelheim Investigational Site
Hong Kong
205.372.85201 Boehringer Ingelheim Investigational Site
Kowloon

Other trials in Hong Kong

Slovakia2 sites

205.372.42102 Boehringer Ingelheim Investigational Site
Bratislava
205.372.42103 Boehringer Ingelheim Investigational Site
Nové Zámky

Other trials in Slovakia

Ireland1 site

205.372.35303 Boehringer Ingelheim Investigational Site
Mullingar

Other trials in Ireland

About this study

Official title: Efficacy {FEV1, COPD Exacerbations & HRQoL} & Safety of 5mcg Tiotropium Respimat in COPD

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Respimat, 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.

RespimatDevice
TiotropiumDrug

Study groups in NCT00387088
Study group	Role	What they receive
Tiotropium	Other	Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded) Receives: Drug: Tiotropium
Placebo	Other	Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded) Receives: Device: Respimat

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337
Trough FEV1 is defined as the FEV1 measured at the -10 min time point at the end of the dosing interval (24 h post drug administration).
Measured: Baseline and Day 337
Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Time to first COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation.
Measured: During actual study treatment period (planned Day 1 to Day 337)

Secondary outcomes (18)

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29
Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.
Measured: Baseline and Day 29
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 169
Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.
Measured: Baseline and Day 169
Number of COPD Exacerbations Per Patient - Exposure Adjusted
Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. number of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)
Measured: During actual study treatment period (planned Day 1 to Day 337)
Number of COPD Exacerbations Per Patient - naïve Estimate
Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)
Measured: During actual study treatment period (planned Day 1 to Day 337)
Number of Patients With at Least One COPD Exacerbation
Number of patients with at least one COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)
Measured: During actual study treatment period (planned Day 1 to Day 337)
Time to First Hospitalisation for COPD Exacerbation
Time to first hospitalisation for COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation
Measured: During actual study treatment period (planned Day 1 to Day 337)
Number of Hospitalisations for COPD Exacerbations Per Patient - Exposure Adjusted
Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. no. of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)
Measured: During actual study treatment period (planned Day 1 to Day 337)
Number of Hospitalisations for COPD Exacerbations Per Patient - naïve Estimate
Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)
Measured: During actual study treatment period (planned Day 1 to Day 337)
Number of Patients With at Least One Hospitalisation for a COPD Exacerbation
Number of patients with at least one hospitalisation for a COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)
Measured: During actual study treatment period (planned Day 1 to Day 337)
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 337
The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state
Measured: Baseline and Day 337
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 169
The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state
Measured: Baseline and Day 169
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 337
The SGRQ domain score (symptom, activity and impact) measures quality of life on a continuous scale ranging from 0=best state to 100=worst state
Measured: Baseline and Day 337
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 169
The SGRQ domain score (symptom, activity and impact) measures quality of life on a continuous scale ranging from 0=best state to 100=worst state
Measured: Baseline and Day 169
Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 29
Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.
Measured: Baseline and Day 29
Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 169
Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.
Measured: Baseline and Day 169
Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 337
Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.
Measured: Baseline and Day 337
Marked Changes From Baseline in Vital Signs at End of Treatment
Marked changes from baseline in vital signs (diastolic and systolic blood pressure (DBP and SBP) and pulse rate (PR)) at end of treatment.
SBP - Increase means SBP >150 mmHg and an increase above baseline of >25 mmHg. SBP - Decrease means SBP <100 mmHg and a decrease below baseline of >10 mmHg.
DBP - Increase means DBP >90 mmHg and an increase above baseline of >10 mmHg. DBP - Decrease means DBP <60 mmHg and a decrease below baseline of >10 mmHg.
PR - Increase means PR >100 bpm and an increase above baseline of >10 bpm. PR - Decrease means PR <60 bpm and a decrease below baseline of >10 bpm.
Measured: Baseline and end of treatment
Clinically Relevant Findings in Physical Examination and ECG
Clinically relevant findings in Physical Examination and ECG at end of treatment
Measured: End of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2006Jan 2009

First posted12 Oct 2006 (estimated)
Study startSep 2006
Primary completionJan 2009

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 (2)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
Intervention model: Parallel groups
Enrolment: 3,991 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00387088
Sponsor's protocol ID: 205.372
Other IDs: 2006-001009-27
Status last verified: Sep 2013
First submitted: 11 Oct 2006
Last updated: 16 May 2014
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 32943047
Bateman ED, Tashkin D, Siafakas N, Dahl R, Towse L, Massey D, Pavia D, Zhong NS. A one-year trial of tiotropium Respimat plus usual therapy in COPD patients. Respir Med. 2010 Oct;104(10):1460-72. doi: 10.1016/j.rmed.2010.06.004.
PubMed 20620037

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy {FEV1, COPD Exacerbations & HRQoL} & Safety of 5mcg Tiotropium Respimat in COPD
ClinicalTrials.gov ID: NCT00387088
Acronym / sponsor ID: 205.372
Conditions: Pulmonary Disease, Chronic Obstructive
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,991 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Sep 2006
Primary completion: Jan 2009 (actual)
First posted: 12 Oct 2006 (estimated)
Results: Posted 22 Jan 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Intervention model: Parallel groups
Number of arms: 2

Arm	Type	Receives
Tiotropium	Other	Drug: TiotropiumTiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Placebo	Other	Device: RespimatPlacebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)

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
At least 40 years old
Smoker or ex-smoker
Smoking history > 10 pack-years
Forced Expiratory Volume in 1 Second (FEV1) < 60% predicted

Key exclusion criteria (6 listed)

Recent history of myocardial infarction, life-threatening cardiac arrhythmia or hospitalisation for cardiac failure
History of asthma or allergic conditions.
Malignancy requiring treatment within past 5 years
Life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
Known active tuberculosis

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
Respimat	Device	Placebo
Tiotropium	Drug	Tiotropium

Primary outcome

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337
Time frame: Baseline and Day 337
Trough FEV1 is defined as the FEV1 measured at the -10 min time point at the end of the dosing interval (24 h post drug administration).
Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Time frame: During actual study treatment period (planned Day 1 to Day 337)
Time to first COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation.

18 secondary outcomes

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29
Time frame: Baseline and Day 29
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 169
Time frame: Baseline and Day 169
Number of COPD Exacerbations Per Patient - Exposure Adjusted
Time frame: During actual study treatment period (planned Day 1 to Day 337)
Number of COPD Exacerbations Per Patient - naïve Estimate
Time frame: During actual study treatment period (planned Day 1 to Day 337)
Number of Patients With at Least One COPD Exacerbation
Time frame: During actual study treatment period (planned Day 1 to Day 337)
Time to First Hospitalisation for COPD Exacerbation
Time frame: During actual study treatment period (planned Day 1 to Day 337)
Number of Hospitalisations for COPD Exacerbations Per Patient - Exposure Adjusted
Time frame: During actual study treatment period (planned Day 1 to Day 337)
Number of Hospitalisations for COPD Exacerbations Per Patient - naïve Estimate
Time frame: During actual study treatment period (planned Day 1 to Day 337)
Number of Patients With at Least One Hospitalisation for a COPD Exacerbation
Time frame: During actual study treatment period (planned Day 1 to Day 337)
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 337
Time frame: Baseline and Day 337
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 169
Time frame: Baseline and Day 169
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 337
Time frame: Baseline and Day 337
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 169
Time frame: Baseline and Day 169
Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 29
Time frame: Baseline and Day 29
Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 169
Time frame: Baseline and Day 169
Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 337
Time frame: Baseline and Day 337
Marked Changes From Baseline in Vital Signs at End of Treatment
Time frame: Baseline and end of treatment
Clinically Relevant Findings in Physical Examination and ECG
Time frame: End of treatment

Results and safety

Results posted to the registry on 22 Jan 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tiotropium	1,989	1,671
Placebo	2,002	1,629

Primary outcome: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337

Time frame: Baseline and Day 337. Least squares mean (Standard Error). Unit: Litres

Measure	Tiotropium n = 1889	Placebo n = 1870
Value	0.119 (0.007)	0.018 (0.007)

Tiotropium vs Placebo: Mean Difference (Final Values): 0.102 (95% CI 0.085 to 0.118), p <0.0001, ANCOVA

Population analysed: The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 133 participants from the FAS were excluded due to insufficient FEV1 data.

Primary outcome: Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

Time frame: During actual study treatment period (planned Day 1 to Day 337). Median (95% Confidence Interval). Unit: Days

Measure	Tiotropium n = 1939	Placebo n = 1953
Value	NA (NA to NA)	NA (354.0 to NA)

Population analysed: The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration until 30 days after last drug administration.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tiotropium	342 of 1,952 (17.5%)	866 of 1,952 (44.4%)	Not reported
Placebo	336 of 1,965 (17.1%)	926 of 1,965 (47.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
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 20620037Bateman ED, Tashkin D, Siafakas N, Dahl R, Towse L, Massey D, Pavia D, Zhong NS. A one-year trial of tiotropium Respimat plus usual therapy in COPD patients. Respir Med. 2010 Oct;104(10):1460-72. doi: 10.1016/j.rmed.2010.06.004.
Related InfoLink provided by the sponsor.

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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

334 sites in 31 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Respimat and Tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 334 sites in 31 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 6 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 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 334 sites in United States, France, United Kingdom, Canada, India and 26 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 22 Jan 2010). 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?

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337 (time frame: Baseline and Day 337). The study lists 2 primary outcomes in all. 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 NCT00387088, which also lists 2 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 16 May 2014.