High Dose Trial in COPD

Phase 2

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT00128440
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objective of this study was to compare the efficacy and safety of 200 μg and 400 μg of BEA 2180 BR to tiotropium 5 μg and placebo when each was delivered by the Respimat® Inhaler once daily for four weeks in patients with COPD.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-08-09
• Study First Submitted QC: 2005-08-09
• Study First Posted: 2005-08-10
• Primary Completion: 2006-09
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-28
• Last Update Posted: 2013-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
forced expiratory volume in one second (FEV1) area under curve 3 to 6 hours (AUC0-6h) after four weeks of treatment.	after 4 weeks
Trough forced expiratory volume (FEV1) response	baseline to 24 hours post drug administration

Secondary Outcome Measures

Name	Time	Method
FVC AUC0-6h after 0 and 4 weeks	after 0 and 4 weeks
Individual FEV1 and FVC measurements at each time point	4 weeks
Trough FVC response after 4 weeks	after 4 weeks
Weekly mean number of occasions of rescue therapy used per day [as occasion requires (PRN) albuterol]	4 weeks
Physician's Global Evaluation	4 weeks
All adverse events	28 weeks
FEV1 and FVC peak response after 0 and 4 weeks	after 0 and 4 weeks
Weekly mean pre-dose morning and evening PEFR	4 weeks
COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest	4 weeks
Pulse rate and blood pressure (seated) recorded in conjunction with spirometry for the first three hours following dosing	28 weeks
12-lead ECGs at baseline (-10 minutes) and at 25 minutes, 2 and 6 hours post dose on Day 1 and 29 of each treatment period (Visits 2-9)	28 weeks

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇺🇸 Tacoma, Washington, United States