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
429
Trough FEV1 response
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 (AUC)0-6h and peak response
Time frame: after 0, 1, 4, 8 and 12 weeks
Individual FEV1 and FVC measurements
Time frame: during 12 weeks
Onset and duration of therapeutic response and percentage of responders
Time frame: after 0 and 12 weeks
Weekly mean pre-dose morning and evening PEFR (peak expiratory flow rate)
Time frame: up to 12 weeks
Weekly mean number of occasions of rescue therapy used per day (PRN salbutamol)
Time frame: up to 12 weeks
COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest)
Time frame: up to 15 weeks
Physician's Global Evaluation
Time frame: up to 15 weeks
Number of patients with at least one exacerbation of COPD
Time frame: up to 15 weeks
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Boehringer Ingelheim Investigational Site
Berlin, Germany
MEDARS GmbH
Berlin, Germany
Boehringer Ingelheim Investigational Site
Bonn, Germany
Boehringer Ingelheim Investigational Site
Frankfurt am Main, Germany
Inamed Research GmbH & Co. KG
Gauting, Germany
Pneumologisches Forschungsinstitut GmbH
Großhansdorf, Germany
Pneumologisches Forschungsinstitut GmbH am Krankenhaus
Hamburg, Germany
Boehringer Ingelheim Investigational Site
Hanover, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, Germany
ClinPharm International GmbH & Co. KG
Leipzig, Germany
...and 28 more locations
Time to first exacerbation
Time frame: up to 15 weeks
Number of exacerbations and exacerbation days
Time frame: up to 15 weeks