A Comparison of 18g of Tiotropium Inhalation Capsules Once Daily and Atrovent Metered Dose Inhaler (2 Puffs of 20g, 4 Times Daily) in a Double-Blind, Double-Dummy, Efficacy and Safety Study in Adults With Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
Drug: tiotropium inhalation powder capsule
Drug: ipratropium bromide Metered Dose Inhaler
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Comparison of 18 mg of Tiotropium Inhalation Capsules Once Daily and Atrovent Metered Dose Inhaler (2 Puffs of 20 mg, Four Times Daily) in a Double-Blind, Double-dummy, Efficacy and Safety Study in Adults With Chronic Obstructive Pulmonary Disease (COPD).|
- Trough FEV1 response: change from baseline trough FEV1 (visit 2) at visit 4
- Trough FEV1 response at visit 3 Average FEV1 (AUC0-3) response (change from baseline) for the 3 hours post drug administration Trough FVC response Average FVC (AUC0-3) response (as defined for FEV1) 5. Amount of rescue medication 6. Patient questionnaire
|Study Start Date:||June 2003|
|Estimated Study Completion Date:||March 2004|
This is a randomized, double-blind, double-dummy, parallel group study to compare the bronchodilator efficacy and safety of tiotropium inhalation capsules and Atrovent? MDI in patients with chronic obstructive pulmonary disease (COPD).
Following an initial screening visit, patients will enter a 2-week baseline period. Patients who successfully complete this phase will be randomized into the double-blind portion of the study in which they will receive tiotropium once daily (morning) or Atrovent? four times daily for 4 weeks. Pulmonary function testing will be conducted just prior (i.e. 5 minutes before) to the start of therapy at Visit 2 (i.e. randomization visit after completion of the 2-week run-in period) and at 30, 60, 120 and 180 minutes post-dosing. Pulmonary function testing will be repeated at the same time intervals after 14 days of therapy (visit 3) and at the end of therapy.
Those patients taking theophylline, will be questioned about their last theophylline intake in order to ensure adherence to the washout requirements.
Vital signs will be measured in conjunction with the pulmonary function tests. Adverse events will be recorded throughout the entire run-in and treatment period.
The null hypothesis is that there is no difference in mean response between tiotropium and Atrovent. The alternative hypothesis is that there is a difference in mean response between tiotropium and Atrovent.
The primary pulmonary function variable will be FEV1 (Forced Expiratory Volume in one second) and trough FEV1 response at the end of the four week treatment period, i.e. visit 4, will be the primary efficacy endpoint.
Trough FEV1 is defined as FEV1 at the end of the dosing interval (for tiotropium at approximately 24 hours post treatment administration). On test days (Visits 3 and 4) it is measured by the PFT just prior to dosing. Trough FEV1 response is defined as change from baseline in trough FEV1. Baseline FEV1 is defined as FEV1 measured just prior to first dosing in the morning of randomization visit (Visit 2).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00239434
|Peking Union Medical College Hospital|
|Beijing, China, 100730|
|People Hospital of Beijing University|
|Beijing, China, 100044|
|1st Hospital of Guangzhou Medical College|
|Guangzhou, China, 510120|
|Shanghai 1st People Hospital|
|Shanghai, China, 200080|
|Zhongshan Hospital of Fudan University|
|Shanghai, China, 200032|
|1st Hospital of Chinese Medical University|
|Shenyang, China, 110001|
|Study Chair:||Boehringer Ingelheim Study Coordinator||Boehringer Ingelheim Shanghai|