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 of treatment. | after 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| FEV1 and FVC area under the curve and peak response | after 0, 1, 4, 8 and 12 weeks |
| Individual FEV1 and FVC measurements at each time point | during study course of 12 weeks |
| Therapeutic response and percentage of responders | after 0 and 12 weeks |
| Weekly mean pre-dose morning and evening PEFR | during study course of 12 weeks |
| Trough FEV1 response | after 1, 4 and 8 weeks |
| Number of occasions of rescue therapy used per day (PRN salbutamol) | during study course of 12 weeks |
| COPD symptom scores | during 15 weeks |
| Physician's Global Evaluation | during 15 weeks |
| Number of patients with at least one exacerbation of COPD | 15 weeks |
| Trough FVC response | after 1, 4, 8 and 12 weeks |
| number of exacerbations | 15 weeks |
| number of exacerbation days | 15 weeks |
| Patient satisfaction and preference | 12 weeks |
| All adverse events | during 15 weeks, follow-up period included |
| Pulse rate and blood pressure for the first three hours following dosing | after 0, 1, 4, 8 and 12 weeks |
| Routine blood chemistry, haematology and urinalysis | after 12 weeks |
| 12-lead ECG | after 12 weeks |
| Physical examination | after 12 weeks |
| time to first exacerbation | 15 weeks |
Countries
Canada, United States
Outcome results
None listed