A Randomized, Double Blind , Placebo Controlled Trial to Compare the Effect of Tiotropium Inhalation Capsules on Exercise Tolerance in Patients With COPD Participating in 8 Weeks of Pulmonary Rehabilitation
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 234
- Locations
- 12
- Primary Endpoint
- Change in six minute walk distance after 8 weeks of pulmonary rehabilitation.
Study Overview
Brief Summary
The objective of this trial is to determine whether tiotropium inhalation capsules (Spiriva, Bromuro de Tiotropio), compared to placebo, enhances the improvement in exercise tolerance seen in patients with chronic obstructive pulmonary disease (COPD) who participate in pulmonary rehabilitation.
Detailed Description
This is an 25-week multicenter, single country, randomised, double-blind, placebo-controlled, parallel group study to compare the efficacy of tiotropium inhalation capsules (Spiriva, Bromuro de Tiotropio) in patients with COPD participating in a pulmonary rehabilitation program.
Following an initial screening, patients will perform a six minute walk test (Visit 1) and enter a 4-week run-in period. Patients will subsequently be randomized to tiotropium or placebo inhalation capsules taken once daily in the morning for the next 25 weeks. After successfully completing 4 weeks of study drug self-administration, patients will enter a period of pulmonary rehabilitation.
Pulmonary rehabilitation will include aerobic lower limb exercise 3 times weekly for 8 weeks. After the last pulmonary rehabilitation session, patients will continue on study medication for a 12 week follow-up period.
Six minute walk tests will be repeated during the run-in period at Week 0 (Visit 2) and Week 4 (Visit 3), at the conclusion of the 8 weeks of pulmonary rehabilitation (Visit 6) and the 12 weeks of follow-up (Visit 9).
Pulmonary function testing will be conducted prior to the start of therapy at Visit 1 and at Visits 2 (week 0 ), 3 (week 4 ), 6 (week 13 ) and 9 (week 25 ).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •COPD patients with FEV1 less 60% of predicted FEV1 less 70% of FVC.
Exclusion Criteria
- •Patients with any respiratory infection in the six weeks prior to the Screening Visit or during the run-in period (between Visits 1 and 2).
- •Patients with a recent history (i.e., 6 months - or less) of myocardial infarction.
- •Patients with any cardiac arrhythmia requiring drug therapy in the past year or who have been hospitalized for heart failure within the past three years.
- •Patients with symptomatic benign prostatic hypertrophy or bladder neck obstruction.
- •Patients with known narrow-angle glaucoma.
Outcomes
Primary Outcomes
Change in six minute walk distance after 8 weeks of pulmonary rehabilitation.
Time Frame: week 13
Secondary Outcomes
- Individual FEV1 measurement(week 4, 13, 25)
- Individual FVC measurement(week 4, 13, 25)
- Patient activity measurement(week 4, 9, 13, 17, 21, 25)
- Six minute walk distance(week 13, 25)
- Changes from baseline in Pulse rate and blood pressure in conjunction with spirometry(25 weeks)
- COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest(week 4, 13, 25)
- St. George's Hospital Respiratory Questionnaire (SGRQ)(Time Frame: week 4, 13, 25)
- Transition dyspnea index(week 4, 13, 25)
- Amount of salbutamol therapy used during the treatment period(25 weeks)
- Physician's global evaluation(week 4, 13, 25)
- Number and length of exacerbations of COPD(25 weeks)
- Patient peak flow rates (PEFR) twice daily(25 weeks)
- Occurrence of adverse events(25 weeks)
- Changes in the physical examination from baseline and at the conclusion of patient participation in the trial(25 weeks)