Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
The primary objective was to compare the bronchodilator efficacy of two doses (5 mcg and 10 mcg) of tiotropium inhalation solution delivered by the Respimat inhaler once daily to placebo and to ipratropium bromide MDI four times daily in patients with COPD. The secondary objective was to compare the safety of tiotropium inhalation solution delivered by the Respimat to placebo and ipratropium bromide MDI.
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Outpatients of either sex, aged \>/= 40 years with a diagnosis of COPD (FEV1 \</= 60% predicted \[ECCS criteria\] and FEV1/FVC \</= 70%)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Trough FEV1 response | after 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Trough FVC response | after 1, 4, 8 and 12 weeks |
| FEV1 and FVC area under the curve (AUC)0-6h and peak response | after 0, 1, 4, 8 and 12 weeks |
| Individual FEV1 and FVC measurements | during 12 weeks |
| Onset and duration of therapeutic response and percentage of responders | after 0 and 12 weeks |
| Weekly mean pre-dose morning and evening PEFR (peak expiratory flow rate) | up to 12 weeks |
| Trough FEV1 response | after 1, 4 and 8 weeks |
| COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest) | up to 15 weeks |
| Physician's Global Evaluation | up to 15 weeks |
| Number of patients with at least one exacerbation of COPD | up to 15 weeks |
| Time to first exacerbation | up to 15 weeks |
| Number of exacerbations and exacerbation days | up to 15 weeks |
| Weekly mean number of occasions of rescue therapy used per day (PRN salbutamol) | up to 12 weeks |
Countries
Germany, Italy, South Africa, Switzerland
Outcome results
None listed