Pulmonary Disease, Chronic ObstructivePhase 4NCT00525512
Tiotropium In Exercise
A Phase 4 study testing tiotropium 18 mcg in people with Pulmonary Disease, Chronic Obstructive and Exercise, run by Boehringer Ingelheim at 62 sites in 11 countries.
Trial summary
The objective of this study is to evaluate the effects on exercise duration of 96 weeks treatment with 18 mcg tiotropium (Spiriva HandiHaler) daily as compared to placebo, in patients with COPD. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Exercise
- What is being tested?
- tiotropium 18 mcg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 519 participants
- Where
- 62 sitesin 11 countries
- Study dates
- Aug 2007to Jun 2010
- Phase
- Phase 4
- 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
- All patients must sign an informed consent
- Diagnosis of COPD with specific spirometric criteria (determined at study visits)
- Age >= 40 years
- Medical Research Council Dyspnoea score >= 2
- Current or ex-smoker with a >= 10 pack-year smoking history
- Ability to exercise on treadmill
Who cannot join
- Significant diseases other than COPD such as history of life-threatening pulmonary obstruction, thoracotomy with pulmonary resection, interstitial lung disease, CF, pulmonary thromboembolic disease, clinically evident bronchiectasis, active tuberculosis, or known moderate to severe renal impairment
- Clinical history of asthma
- Use of supplemental oxygen therapy
- Respiratory tract infection or COPD exacerbation in the 6 weeks prior to Visit 1 or during the washout period prior to Visit 3 (may randomize 6 weeks after recovery)
- Recent history (<= 12 months) of myocardial infarction
- Unstable or life-threatening cardiac arrhythmia
Show all 16Show fewer
- Malignancy treated with radiation therapy or chemotherapy in the last 5 years
- Pregnant or nursing women
- Known hypersensitivity to anticholinergic drugs or any component of the study medications
- Participation in pulmonary or cardiac rehab program within 13 weeks of Visit 1
- Estimated life expectancy < 2 years
- Symptomatic prostatic hyperplasia or bladder neck obstruction
- Known narrow-angle glaucoma
- Any condition that is contraindicated for exercise
- Orthopaedic, muscular, neurological or cardiac disease that would interfere with regular participation in aerobic exercise or with exercise testing
- Body mass index < 18 kg/m2 or >35 kg/m2 list truncated for space
Trial locations and contacts
62 sites in 11 countries.
62 sites in 11 countries
United States21 sites
205.368.01014 Boehringer Ingelheim Investigational Site
Albany, New York
205.368.01016 Boehringer Ingelheim Investigational Site
Baltimore, Maryland
205.368.01004 Boehringer Ingelheim Investigational Site
Bay Pines, Florida
205.368.01029 Boehringer Ingelheim Investigational Site
Biddeford, Maine
205.368.01002 Boehringer Ingelheim Investigational Site
Boston, Massachusetts
205.368.01018 Boehringer Ingelheim Investigational Site
Charleston, South Carolina
205.368.01015 Boehringer Ingelheim Investigational Site
Dallas, Texas
205.368.01008 Boehringer Ingelheim Investigational Site
Fort Collins, Colorado
205.368.01027 Boehringer Ingelheim Investigational Site
Gaffney, South Carolina
205.368.01019 Boehringer Ingelheim Investigational Site
Greenville, South Carolina
205.368.01017 Boehringer Ingelheim Investigational Site
Hartford, Connecticut
205.368.01025 Boehringer Ingelheim Investigational Site
Hazard, Kentucky
205.368.01023 Boehringer Ingelheim Investigational Site
Jasper, Alabama
205.368.01021 Boehringer Ingelheim Investigational Site
Kansas City, Missouri
205.368.01003 Boehringer Ingelheim Investigational Site
Los Angeles, California
205.368.01013 Boehringer Ingelheim Investigational Site
North Miami Beach, Florida
205.368.01022 Boehringer Ingelheim Investigational Site
Phoenix, Arizona
205.368.01020 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina
205.368.01030 Boehringer Ingelheim Investigational Site
Tulsa, Oklahoma
205.368.01024 Boehringer Ingelheim Investigational Site
Union, South Carolina
205.368.01028 Boehringer Ingelheim Investigational Site
Waterbury, Connecticut
Canada6 sites
205.368.07004 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
205.368.07005 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
205.368.07008 Boehringer Ingelheim Investigational Site
Montreal, Quebec
205.368.07006 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
205.368.07001 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba
205.368.07003 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba
Germany6 sites
205.368.49005 Boehringer Ingelheim Investigational Site
Berlin
205.368.49003 Boehringer Ingelheim Investigational Site
Cologne
205.368.49004 Boehringer Ingelheim Investigational Site
Freiburg/Breisgau
205.368.49006 Boehringer Ingelheim Investigational Site
Münster
205.368.49002 Boehringer Ingelheim Investigational Site
Schmallenberg
205.368.49001 Boehringer Ingelheim Investigational Site
Tübingen
Spain6 sites
205.368.34005 Hospital Germans Trias i Pujol
Badalona (Barcelona)
205.368.34002 Hospital de Cruces
Barakaldo (Bilbao)
205.368.34001 Hospital Clinic i Provincial de Barcelona
Barcelona
205.368.34003 Hospital Gregorio Maranon
Madrid
205.368.34004 Hospital Universitario Vírgen del Rocío
Seville
205.368.34006 Boehringer Ingelheim Investigational Site
Seville
Russia5 sites
205.368.70001 Boehringer Ingelheim Investigational Site
Moscow
205.368.70004 Boehringer Ingelheim Investigational Site
Moscow
205.368.70005 Boehringer Ingelheim Investigational Site
Moscow
205.368.70006 Boehringer Ingelheim Investigational Site
Moscow
205.368.70007 Boehringer Ingelheim Investigational Site
Saint Petersburg
Italy4 sites
205.368.39006 Boehringer Ingelheim Investigational Site
Ferrara
205.368.39004 Boehringer Ingelheim Investigational Site
Milan
205.368.39002 Boehringer Ingelheim Investigational Site
Parma
205.368.39001 Boehringer Ingelheim Investigational Site
Pisa
Taiwan4 sites
205.368.88604 Boehringer Ingelheim Investigational Site
Keelung
205.368.88602 Boehringer Ingelheim Investigational Site
Taichung
205.368.88603 Boehringer Ingelheim Investigational Site
Taipei
205.368.88601 Chang Gung Memorial Hosp-Linkou
Taoyuan
Brazil3 sites
205.368.55003 Boehringer Ingelheim Investigational Site
Goiânia
205.368.55004 Boehringer Ingelheim Investigational Site
Porto Alegre - RS
205.368.55002 Boehringer Ingelheim Investigational Site
São Paulo
Ukraine3 sites
205.368.38003 Boehringer Ingelheim Investigational Site
Dnyepropyetrovsk
205.368.38001 Boehringer Ingelheim Investigational Site
Kiev
205.368.38002 Boehringer Ingelheim Investigational Site
Kiev
Argentina2 sites
205.368.54001 Boehringer Ingelheim Investigational Site
Rosario
205.368.54002 Boehringer Ingelheim Investigational Site
Vicente López
Portugal2 sites
205.368.35103 Boehringer Ingelheim Investigational Site
Coimbra
205.368.35102 Boehringer Ingelheim Investigational Site
Matosinhos Municipality
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Two-year Trial to Examine the Changes in Exercise Endurance and COPD Treated With Tiotropium Once Daily (EXACTT)
The objective of this study is to evaluate the effects on exercise duration of 96 weeks treatment with 18 mcg tiotropium (Spiriva HandiHaler) daily as compared to placebo, in patients with COPD.
- Conditions
- Pulmonary Disease, Chronic Obstructive, Exercise
- Being tested
- tiotropium 18 mcg, Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tiotropium 18 mcgDrug
Oral inhalation once daily of 18mcg tiotropium via handihaler
PlaceboDrug
Oral inhalation of once-daily placebo matching tiotropium via handihaler
| Study group | Role | What they receive |
|---|---|---|
| tiotropium 18mcg | Experimental | Oral inhalation once daily of 18mcg tiotropium via handihaler Receives: Drug: tiotropium 18 mcg |
| Placebo | Placebo comparator | Oral inhalation once daily of placebo matching tiotropium via handihaler Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
Measured: baseline, 96 weeks
Secondary outcomes (64)
90% Constant Work Rate (CWR) Treadmill Endurance Time at 8 Weeks - Double-Blind Phase
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
Measured: baseline, 8 weeks
90% Constant Work Rate (CWR) Treadmill Endurance Time at 16 Weeks - Double-Blind Phase
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
Measured: baseline, 16 weeks
90% Constant Work Rate (CWR) Treadmill Endurance Time at 32 Weeks - Double-Blind Phase
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
Measured: baseline, 32 weeks
90% Constant Work Rate (CWR) Treadmill Endurance Time at 48 Weeks - Double-Blind Phase
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
Measured: baseline, 48 weeks
90% Constant Work Rate (CWR) Treadmill Endurance Time at 64 Weeks - Double-Blind Phase
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
Measured: baseline, 64 weeks
90% Constant Work Rate (CWR) Treadmill Endurance Time at 80 Weeks - Double-Blind Phase
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
Measured: baseline, 80 weeks
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase
FEV1 is the maximal amount of air you can forcefully exhale in one second.
Measured: baseline, 8 weeks
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase
FEV1 is the maximal amount of air you can forcefully exhale in one second.
Measured: baseline, 16 weeks
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase
FEV1 is the maximal amount of air you can forcefully exhale in one second.
Measured: baseline, 32 weeks
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase
FEV1 is the maximal amount of air you can forcefully exhale in one second.
Measured: baseline, 48 weeks
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase
FEV1 is the maximal amount of air you can forcefully exhale in one second.
Measured: baseline, 64 weeks
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase
FEV1 is the maximal amount of air you can forcefully exhale in one second.
Measured: baseline, 80 weeks
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase
FEV1 is the maximal amount of air you can forcefully exhale in one second.
Measured: baseline, 96 weeks
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase
FEV1 is the maximal amount of air you can forcefully exhale in one second.
Measured: baseline, 8 weeks
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase
FEV1 is the maximal amount of air you can forcefully exhale in one second.
Measured: baseline, 16 weeks
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase
FEV1 is the maximal amount of air you can forcefully exhale in one second.
Measured: baseline, 32 weeks
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase
FEV1 is the maximal amount of air you can forcefully exhale in one second.
Measured: baseline, 48 weeks
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase
FEV1 is the maximal amount of air you can forcefully exhale in one second.
Measured: baseline, 64 weeks
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase
FEV1 is the maximal amount of air you can forcefully exhale in one second.
Measured: baseline, 80 weeks
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase
FEV1 is the maximal amount of air you can forcefully exhale in one second.
Measured: baseline, 96 weeks
Pre-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase
FVC is the volume of air that can be forcibly blown out after full inspiration.
Measured: baseline, 8 weeks
Pre-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase
FVC is the volume of air that can be forcibly blown out after full inspiration.
Measured: baseline, 16 weeks
Pre-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase
FVC is the volume of air that can be forcibly blown out after full inspiration.
Measured: baseline, 32 weeks
Pre-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase
FVC is the volume of air that can be forcibly blown out after full inspiration.
Measured: baseline, 48 weeks
Pre-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase
FVC is the volume of air that can be forcibly blown out after full inspiration.
Measured: baseline, 64 weeks
Pre-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase
FVC is the volume of air that can be forcibly blown out after full inspiration.
Measured: baseline, 80 weeks
Pre-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase
FVC is the volume of air that can be forcibly blown out after full inspiration.
Measured: baseline, 96 weeks
Post-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase
FVC is the volume of air that can be forcibly blown out after full inspiration.
Measured: baseline, 8 weeks
Post-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase
FVC is the volume of air that can be forcibly blown out after full inspiration.
Measured: baseline, 16 weeks
Post-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase
FVC is the volume of air that can be forcibly blown out after full inspiration.
Measured: baseline, 32 weeks
Post-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase
FVC is the volume of air that can be forcibly blown out after full inspiration.
Measured: baseline, 48 weeks
Post-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase
FVC is the volume of air that can be forcibly blown out after full inspiration.
Measured: baseline, 64 weeks
Post-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase
FVC is the volume of air that can be forcibly blown out after full inspiration.
Measured: baseline, 80 weeks
Post-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase
FVC is the volume of air that can be forcibly blown out after full inspiration.
Measured: baseline, 96 weeks
Borg Scale of Dyspnea at Isotime After 96 Weeks - Double-Blind Phase
Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)
Measured: baseline, 96 weeks
Borg Scale of Peak Dyspnea After 96 Weeks - Double-Blind Phase
Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)
Measured: baseline, 96 weeks
Borg Scale of Peak Leg Discomfort After 96 Weeks - Double-Blind Phase
Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)
Measured: baseline, 96 weeks
Change From Baseline in Physician Global Evaluation at 8 Weeks - Double-Blind Phase
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Measured: baseline, 8 weeks
Change From Baseline in Physician Global Evaluation at 16 Weeks - Double-Blind Phase
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Measured: baseline, 16 weeks
Change From Baseline in Physician Global Evaluation at 32 Weeks - Double-Blind Phase
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Measured: baseline, 32 weeks
Change From Baseline in Physician Global Evaluation at 48 Weeks - Double-Blind Phase
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Measured: baseline, 48 weeks
Change From Baseline in Physician Global Evaluation at 64 Weeks - Double-Blind Phase
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Measured: baseline, 64 weeks
Change From Baseline in Physician Global Evaluation at 80 Weeks - Double-Blind Phase
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Measured: baseline, 80 weeks
Change From Baseline in Physician Global Evaluation at 96 Weeks - Double-Blind Phase
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Measured: baseline, 96 weeks
Change From Baseline in Patient Global Evaluation at 8 Weeks - Double-Blind Phase
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Measured: baseline, 8 weeks
Change From Baseline in Patient Global Evaluation at 16 Weeks - Double-Blind Phase
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Measured: baseline, 16 weeks
Change From Baseline in Patient Global Evaluation at 32 Weeks - Double-Blind Phase
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Measured: baseline, 32 weeks
Change From Baseline in Patient Global Evaluation at 48 Weeks - Double-Blind Phase
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Measured: baseline, 48 weeks
Change From Baseline in Patient Global Evaluation at 64 Weeks - Double-Blind Phase
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Measured: baseline, 64 weeks
Change From Baseline in Patient Global Evaluation at 80 Weeks - Double-Blind Phase
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Measured: baseline, 80 weeks
Change From Baseline in Patient Global Evaluation at 96 Weeks - Double-Blind Phase
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Measured: baseline, 96 weeks
Saint George's Respiratory Questionnaire Total Score at 96 Weeks - Double-Blind Phase
Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
Measured: baseline, 96 weeks
Saint George's Respiratory Questionnaire Activity Component Score at 96 Weeks - Double-Blind Phase
Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
Measured: baseline, 96 weeks
Saint George's Respiratory Questionnaire Impact Component Score at 96 Weeks - Double-Blind Phase
Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
Measured: baseline, 96 weeks
Saint George's Respiratory Questionnaire Symptoms Component Score at 96 Weeks - Double-Blind Phase
Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
Measured: baseline, 96 weeks
Patients With COPD Exacerbation (Survival Analysis) - Double-Blind Phase
COPD exacerbation is a complex of symptoms related to COPD with a duration of three days or more requiring a change of treatment.
Measured: baseline, 96 weeks
90% Constant Work Rate (CWR) Treadmill Endurance Time at 100 Weeks - Open-Label Phase
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
Measured: baseline, 100 weeks
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 100 Weeks - Open-Label Phase
FEV1 is the maximal amount of air you can forcefully exhale in one second.
Measured: baseline, 100 weeks
Post-treatment Forced Vital Capacity (FVC) at 100 Weeks - Open-Label Phase
FVC is the volume of air that can be forcibly blown out after full inspiration.
Measured: baseline, 100 weeks
Saint George's Respiratory Questionnaire Total Score at 100 Weeks - Open-Label Phase
Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
Measured: baseline, 100 weeks
Saint George's Respiratory Questionnaire Activity Component Score at 100 Weeks - Open-Label Phase
Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
Measured: baseline, 100 weeks
Saint George's Respiratory Questionnaire Impact Component Score at 100 Weeks - Open-Label Phase
Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
Measured: baseline, 100 weeks
Saint George's Respiratory Questionnaire Symptoms Component Score at 100 Weeks - Open-Label Phase
Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
Measured: baseline, 100 weeks
Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status
Clinical Relevant Abnormalities for Vital Signs and Physical examination, including vital status. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Events.
Measured: From first drug administration until 30 days after last drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2007 (estimated)
- Study startAug 2007
- Primary completionJun 2010
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 (1)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 519 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525512
- Sponsor's protocol ID
- 205.368
- Other IDs
- 2006-004610-41
- Status last verified
- Sep 2013
- First submitted
- 3 Sep 2007
- Last updated
- 24 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Cooper CB, Celli BR, Jardim JR, Wise RA, Legg D, Guo J, Kesten S. Treadmill endurance during 2-year treatment with tiotropium in patients with COPD: a randomized trial. Chest. 2013 Aug;144(2):490-497. doi: 10.1378/chest.12-2613.
PubMed 23558890
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Two-year Trial to Examine the Changes in Exercise Endurance and COPD Treated With Tiotropium Once Daily (EXACTT)
- ClinicalTrials.gov ID
- NCT00525512
- Acronym / sponsor ID
- 205.368
- Conditions
- Pulmonary Disease, Chronic Obstructive, Exercise
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 519 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Aug 2007
- Primary completion
- Jun 2010 (actual)
- First posted
- 5 Sep 2007 (estimated)
- Results
- Posted 23 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the effects on exercise duration of 96 weeks treatment with 18 mcg tiotropium (Spiriva HandiHaler) daily as compared to placebo, in patients with COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tiotropium 18mcg | Experimental | Drug: tiotropium 18 mcgOral inhalation once daily of 18mcg tiotropium via handihaler |
| Placebo | Placebo comparator | Drug: PlaceboOral inhalation once daily of placebo matching tiotropium via handihaler |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All patients must sign an informed consent
- Diagnosis of COPD with specific spirometric criteria (determined at study visits)
- Age >= 40 years
- Medical Research Council Dyspnoea score >= 2
- Current or ex-smoker with a >= 10 pack-year smoking history
Key exclusion criteria (16 listed)
- Significant diseases other than COPD such as history of life-threatening pulmonary obstruction, thoracotomy with pulmonary resection, interstitial lung disease, CF, pulmonary thromboembolic disease, clinically evident bronchiectasis, active tuberculosis, or known moderate to severe renal impairment
- Clinical history of asthma
- Use of supplemental oxygen therapy
- Respiratory tract infection or COPD exacerbation in the 6 weeks prior to Visit 1 or during the washout period prior to Visit 3 (may randomize 6 weeks after recovery)
- Recent history (<= 12 months) of myocardial infarction
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 |
|---|---|---|
| tiotropium 18 mcgOral inhalation once daily of 18mcg tiotropium via handihaler | Drug | tiotropium 18mcg |
| PlaceboOral inhalation of once-daily placebo matching tiotropium via handihaler | Drug | Placebo |
Primary outcome
90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase
Time frame: baseline, 96 weeks
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
64 secondary outcomes
90% Constant Work Rate (CWR) Treadmill Endurance Time at 8 Weeks - Double-Blind Phase
Time frame: baseline, 8 weeks
90% Constant Work Rate (CWR) Treadmill Endurance Time at 16 Weeks - Double-Blind Phase
Time frame: baseline, 16 weeks
90% Constant Work Rate (CWR) Treadmill Endurance Time at 32 Weeks - Double-Blind Phase
Time frame: baseline, 32 weeks
90% Constant Work Rate (CWR) Treadmill Endurance Time at 48 Weeks - Double-Blind Phase
Time frame: baseline, 48 weeks
90% Constant Work Rate (CWR) Treadmill Endurance Time at 64 Weeks - Double-Blind Phase
Time frame: baseline, 64 weeks
90% Constant Work Rate (CWR) Treadmill Endurance Time at 80 Weeks - Double-Blind Phase
Time frame: baseline, 80 weeks
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase
Time frame: baseline, 8 weeks
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase
Time frame: baseline, 16 weeks
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase
Time frame: baseline, 32 weeks
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase
Time frame: baseline, 48 weeks
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase
Time frame: baseline, 64 weeks
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase
Time frame: baseline, 80 weeks
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase
Time frame: baseline, 96 weeks
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase
Time frame: baseline, 8 weeks
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase
Time frame: baseline, 16 weeks
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase
Time frame: baseline, 32 weeks
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase
Time frame: baseline, 48 weeks
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase
Time frame: baseline, 64 weeks
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase
Time frame: baseline, 80 weeks
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase
Time frame: baseline, 96 weeks
Pre-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase
Time frame: baseline, 8 weeks
Pre-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase
Time frame: baseline, 16 weeks
Pre-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase
Time frame: baseline, 32 weeks
Pre-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase
Time frame: baseline, 48 weeks
Pre-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase
Time frame: baseline, 64 weeks
Pre-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase
Time frame: baseline, 80 weeks
Pre-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase
Time frame: baseline, 96 weeks
Post-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase
Time frame: baseline, 8 weeks
Post-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase
Time frame: baseline, 16 weeks
Post-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase
Time frame: baseline, 32 weeks
Post-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase
Time frame: baseline, 48 weeks
Post-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase
Time frame: baseline, 64 weeks
Post-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase
Time frame: baseline, 80 weeks
Post-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase
Time frame: baseline, 96 weeks
Borg Scale of Dyspnea at Isotime After 96 Weeks - Double-Blind Phase
Time frame: baseline, 96 weeks
Borg Scale of Peak Dyspnea After 96 Weeks - Double-Blind Phase
Time frame: baseline, 96 weeks
Borg Scale of Peak Leg Discomfort After 96 Weeks - Double-Blind Phase
Time frame: baseline, 96 weeks
Change From Baseline in Physician Global Evaluation at 8 Weeks - Double-Blind Phase
Time frame: baseline, 8 weeks
Change From Baseline in Physician Global Evaluation at 16 Weeks - Double-Blind Phase
Time frame: baseline, 16 weeks
Change From Baseline in Physician Global Evaluation at 32 Weeks - Double-Blind Phase
Time frame: baseline, 32 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23558890Cooper CB, Celli BR, Jardim JR, Wise RA, Legg D, Guo J, Kesten S. Treadmill endurance during 2-year treatment with tiotropium in patients with COPD: a randomized trial. Chest. 2013 Aug;144(2):490-497. doi: 10.1378/chest.12-2613.
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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
62 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tiotropium 18 mcg in people with Pulmonary Disease, Chronic Obstructive and Exercise, run by Boehringer Ingelheim at 62 sites in 11 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 6 inclusion and 16 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 24 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United States, Canada, Germany, Spain, Russia and 6 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 23 Sep 2011). 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?
90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase (time frame: baseline, 96 weeks). 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 NCT00525512, which also lists 1 linked publication.
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 24 Dec 2013.