A Randomised, Double-blind, Crossover Study of Ba679BR Respimat in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Phase 2

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT00292448
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The objective of this trial is to compare the efficacy and the safety of Ba 679 BR Respimat 5 ug once daily to tiotropium inhalation capsule 18 ug (Spiriva inhalation capsule) in a crossover study of 4-week treatment periods in patients with COPD.

Detailed Description

This is a 16-week, multi-centre, randomised, double-blind, double-dummy, crossover study of 4-week randomised treatment periods to demonstrate the efficacy and safety of 5 ug of Ba 679 BR inhalation solution from Respimat compared to tiotropium inhalation powder capsule (18 ug) via HandiHaler in patients with COPD. The two 4-week randomised treatment periods are separated by 4-week washout period.

Study Hypothesis:

The primary aim of this trial is to demonstrate non-inferiority of lung function response to 5 ug (2 actuations of 2.5 ug) of Ba679BR Respimat delivered by the Respimat inhaler once daily compared to tiotropium (18 ug) inhaled as powder capsule from the HandiHaler once daily at the end of 4-week treatment periods in patients with COPD. The hypothesis test of non-inferiority will be performed at alpha = 0.025 (one-sided).

Comparison(s):

The primary efficacy endpoint is the trough FEV1 response determined at the end of each 4-week period of randomised treatment.

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-02-15
• Study First Submitted QC: 2006-02-15
• Study First Posted: 2006-02-16
• Study Completion: 2007-03
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-28
• Last Update Posted: 2013-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
The primary outcome is the trough FEV1 response determined at the end of each 4-week period of randomised treatment.

Secondary Outcome Measures

Name	Time	Method
Trough FVC response after 4 weeks, peak response (FEV1 and FVC) to first dose, peak response (FEV1 and FVC) after 4 weeks, FEV1 AUC0-3h and FVC AUC0-3h response to first dose and after 4 weeks, individual FEV1and FVC measurements at each time point.

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇯🇵 Yokote, Akita, Japan