A Multiple Dose Comparison of Tiotropium Inhalation Capsules and Salmeterol Inhalation Aerosol.
The objective of the study was to evaluate the degree of improvement in lung function in patients with chronic obstructive pulmonary disease (COPD) after treatment with tiotropium inhalation capsules compared to salmeterol inhalation aerosol .
Pulmonary Disease, Chronic Obstructive
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Multiple Dose Comparison of Tiotropium Inhalation Capsules and Salmeterol Inhalation Aerosol in a 12 Week, Randomized, Double-Blind, Double-Dummy Parallel Group Study in Patients With Chronic Obstructive Pulmonary Disease (COPD).|
- There were two primary endpoints: FEV1 area under the curve for the time period of 0 to 12 hours (FEV1 AUC0-12) and peak FEV1. Both endpoints were measured after 12 weeks of treatment, at the final study visit (Visit 4).
- Trough (predose) FEV1 Trough, peak and FVC AUC0-12 FEV1 and FVC at individual timepoints Amount of albuterol therapy used during the treatment period Number (%) of patients with at one exacerbation of COPD and time to first exacerbation
|Study Start Date:||May 2002|
|Estimated Study Completion Date:||October 2003|
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|Study Chair:||Boehringer Ingelheim Study Coordinator||Boehringer Ingelheim Pharmaceuticals|