Effects of Inhaled Tiotropium Bromide on Severity of Airflow Obstruction During Long-term Treatment in Patients With Moderately Severe Copd. Impact on Severity and Incidence of Exacerbations.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 1,000
- Locations
- 95
- Primary Endpoint
- morning peak expiratory flow rate (PEFR)
Study Overview
Brief Summary
The objectives of this study were to evaluate the effect of a one-year treatment with inhaled tiotropium bromide 18 mcg once daily on lung function, incidence and severity of exacerbations in patients with chronic obstructive pulmonary disease (COPD).
The secondary purpose was to explore possible relationships between lung function changes and occurrence of COPD exacerbations and to try to characterize these exacerbations.
Detailed Description
This was a multicentre, randomised, double blind, parallel group, placebo-controlled, one year study. It was designed to determine the effect of inhaled tiotropium treatment on airflow obstruction (PEFR), incidence and severity of exacerbations in patients with COPD.
Following an initial 3-week screening period qualifying patients were randomized to either tiotropium or placebo at Visit 2. Patients returned to the clinic at weeks 6 (Visit 3), 12 (Visit 4), 24 (Visit 5), 36 (Visit 6), 48 (Visit 7) and at Week 50 for the conclusion of the trial (Visit 8). The patients received treatment daily for 48 weeks (336 days).
PEFR, as well as use of rescue medication and respiratory condition, were self-assessed by patients and recorded every morning on a graphical diary card every morning. The graphical presentation of these data was supposed to help investigators to detect exacerbations occurring between two consecutive visits.
Details on hospitalizations due to COPD exacerbations were recorded in a special hospitalization booklet.
Study Hypothesis:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 41 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
morning peak expiratory flow rate (PEFR)
Time Frame: 50 weeks
Secondary Outcomes
- spirometric evaluation (FEV1, FVC, SVC, MEF25-75 ) and optional measurements (IC)(50 weeks)
- Adverse events, physical examination(50 weeks)
- incidence, severity and duration of exacerbations(50 weeks)
- number of patients with one or more exacerbation(50 weeks)
- rate of PEFR drops(50 weeks)
- number of lost working days(50 weeks)
- bacterial and viral characterisation of severe exacerbations(50 weeks)
- plethysmography (RV, TLC) (optional)(50 weeks)
- number of days of hospitalisation(50 weeks)
- use of rescue medications, type and duration(50 weeks)