Efficacy and Safety of Tiotropium Inhalation Capsules and Atrovent MDI in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Phase 3

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT00274092
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The objective of this study is to compare the bronchodilator efficacy and safety of tiotropium inhalation capsules (18 mcg once daily) and Atrovent MDI (2 puffs of 20 mcg q.i.d.) in patients with chronic obstructive pulmonary disease (COPD)

Detailed Description

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. Pulmonary function testing will be conducted just prior to the start of therapy at Visit 2 (i.e. randomization visit after completion of the 2-week run-in period) and at 120 minutes post-dosing. Pulmonary function testing will be repeated at the same time intervals at the end of therapy.

Study Hypothesis:

Null and alternative hypotheses The primary objective of this study was addressed by a two-sided test at the 0.05 level of significance of the null hypothesis that, in patients with chronic obstructive pulmonary disease (COPD), the bronchodilator efficacy after one month is no greater on tiotropium inhalation capsules (18mcg once daily) than on ATROVENT MDI (2 puffs of 20 mcg q.i.d.), against the alternative hypothesis that the bronchodilator efficacy is greater on tiotropium inhalation capsules (18 mcg once daily).

Comparison(s):

Trough FEV1 response will be analyzed. Peak FEV1, FVC trough and peak response, number of Rescue Medication and change from baseline in total score of Patient Evaluation Questionnaire will be analyzed. Change from baseline in each category score of Patient Evaluation Questionnaire will be also analyzed.

Study Timeline

• Study Start: 2002-09
• Primary Completion: 2003-10
• Study Completion: 2003-10
• Study First Submitted: 2006-01-09
• Study First Submitted QC: 2006-01-09
• Study First Posted: 2006-01-10
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-04
• Last Update Posted: 2013-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary endpoint is trough FEV1 response which is defined as change from baseline FEV1 (visit 2) and trough FEV1 at week 4 (visit 4)

Secondary Outcome Measures

Name	Time	Method
FEV1 and FVC response at 2 hours post drug administration at on each pulmonary test day; Trough FVC response; Number of rescue medications; and Change from baseline in total score of patient evaluation questionnaire at week 4 (visit 4).

Trial Locations

Locations (5)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan

Veterans General Hospital; 🇨🇳 Taipei, Taiwan

Tri-Service General Hospital; 🇨🇳 Taipei, Taiwan