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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
491
Boehringer Ingelheim Investigational Site
Trough FEV1 response after 12 weeks of treatment.
Time frame: after 12 weeks
Trough FEV1 response
Time frame: after 1, 4 and 8 weeks
Trough FVC response
Time frame: after 1, 4, 8 and 12 weeks
FEV1 and FVC area under the curve and peak response
Time frame: after 0, 1, 4, 8 and 12 weeks
Individual FEV1 and FVC measurements at each time point
Time frame: during study course of 12 weeks
Therapeutic response and percentage of responders
Time frame: after 0 and 12 weeks
Weekly mean pre-dose morning and evening PEFR
Time frame: during study course of 12 weeks
Number of occasions of rescue therapy used per day (PRN salbutamol)
Time frame: during study course of 12 weeks
COPD symptom scores
Time frame: during 15 weeks
Physician's Global Evaluation
Time frame: during 15 weeks
Number of patients with at least one exacerbation of COPD
Time frame: 15 weeks
time to first exacerbation
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Birmingham, Alabama, United States
Boehringer Ingelheim Investigational Site
Downey, California, United States
University of California - Los Angeles
Los Angeles, California, United States
Boehringer Ingelheim Investigational Site
Palo Alto, California, United States
Rocky Mountain Center for Clinical Research
Wheat Ridge, Colorado, United States
Boehringer Ingelheim Investigational Site
Bay Pines, Florida, United States
Boehringer Ingelheim Investigational Site
Clearwater, Florida, United States
Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida, United States
Boehringer Ingelheim Investigational Site
Wheaton, Maryland, United States
Boehringer Ingelheim Investigational Site
St Louis, Missouri, United States
...and 15 more locations
Time frame: 15 weeks
number of exacerbations
Time frame: 15 weeks
number of exacerbation days
Time frame: 15 weeks
Patient satisfaction and preference
Time frame: 12 weeks
All adverse events
Time frame: during 15 weeks, follow-up period included
Pulse rate and blood pressure for the first three hours following dosing
Time frame: after 0, 1, 4, 8 and 12 weeks
Routine blood chemistry, haematology and urinalysis
Time frame: after 12 weeks
12-lead ECG
Time frame: after 12 weeks
Physical examination
Time frame: after 12 weeks