| July 9, 2007 |
| October 12, 2009 |
| April 2007 |
| July 2010 (final data collection date for primary outcome measure) |
| The primary endpoint is improvement in lung function as measured by the forced expiratory volume in 1 second (FEV1) AUC0 3h post dose response at week 24 (end of study). [ Time Frame: 24 weeks ] |
| The primary endpoint is improvement in lung function as measured by the forced expiratory volume in 1 second (FEV1) AUC0 3h post dose response at week 24 (end of study). |
| Complete list of historical versions of study NCT00523991 on ClinicalTrials.gov Archive Site |
| FEV1 and FVC parameters Physical activity and energy expenditure as determined by the activity monitor Physician´s and patient global assessments Work productivity Use of rescue medication prn albuterol (salbutamol) [ Time Frame: 24 weeks ] |
| FEV1 and FVC parameters Physical activity and energy expenditure as determined by the activity monitor Physician's and patient global assessments Work productivity Use of rescue medication prn albuterol (salbutamol) |
| |
| Trial Comparing Tiotropium Inhalation Capsules vs Placebo in Chronic Obstructive Pulmonary Disease (COPD). |
| A 24 Week, Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of 18 MCG of Tiotropium Inhalation Capsules Administered by HandiHaler Once-daily Plus PRN Albuterol (Salbutamol) vs. Placebo Plus PRN Albuterol (Salbutamol) in Chronic Obstructive Pulmonary Disease Subjects Naive to Maintenance Therapy |
A 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 18mcg of tiotropium inhalation capsules administered by Handihaler once daily plus PRN albuterol (salbutamol) vs. placebo plus PRN albuterol (salbutamol) in chronic obstructive pulmonary disease subjects naive to maintenance therapy. |
| |
| Phase IV |
| Interventional |
| Treatment, Parallel Assignment, Safety/Efficacy Study |
| Pulmonary Disease, Chronic Obstructive |
| Drug: tiotropium inhalation capsules |
| |
| |
| |
| Recruiting |
| 436 |
|
| July 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- All subjects must have a diagnosis of COPD according to GOLD guideline criteria:
- post-bronchodilator FEV1/FVC ratio < 70% (visit 1).
- Subjects must be GOLD Stage II and have a post-bronchodilator FEV1 >50% and < 80% of predicted normal (visit 1).
- Subjects must be current or ex-smokers with a smoking history of >=10 pack years.
- Subjects must have a Medical Research Council (MRC) dyspnea score >= 2.
Exclusion Criteria:
- Subjects who have been treated with maintenance medications for chronic respiratory disease within six months prior to screening.
- Subjects with significant diseases other than COPD. Subjects on chronic systemic corticosteroids.
- Subjects with any upper and/or lower respiratory tract infection or COPD exacerbation in the 6 weeks prior to the initial visit 1 or during the screening period prior to visit 3
- Subjects with a recent (past 6 months) myocardial infarction, any unstable or life threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year; or who have been hospitalized for cardiac failure during the past year.
|
| Both |
| 40 Years to 80 Years |
| No |
|
|
| United States, Belgium, Canada, Czech Republic, Germany, Greece, Netherlands, Portugal, Ukraine, United Kingdom |
| |
| NCT00523991 |
| Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| 205.365, 2006-006276-38
A4471008 |
| Boehringer Ingelheim Pharmaceuticals |
|
| Study Chair: |
Boehringer Ingelheim |
Boehringer Ingelheim Pharmaceuticals |
|
|
| Boehringer Ingelheim Pharmaceuticals |
| October 2009 |
