Effect of Roflumilast on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BY217/M2-110)

Phase 3

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; COPD

• Registration Number: NCT00062582
• Lead Sponsor: AstraZeneca

Brief Summary

The aim of the study is to compare the effect of roflumilast and placebo on the lung function in patients with COPD.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2003-06-09
• Study First Submitted QC: 2003-06-09
• Study First Posted: 2003-06-10
• Status Verified: 2016-09
• Last Update Submitted: 2016-11-22
• Last Update Posted: 2016-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Clinical diagnosis of COPD (Chronic Obstructive Pulmonary Disease)
• Currently stable COPD with no change in COPD treatment in the prior 4 weeks

Main

Exclusion Criteria

• Clinical diagnosis of asthma
• Poorly controlled COPD
• Regular need for daily oxygen therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
pulmonary function.

Secondary Outcome Measures

Name	Time	Method
exacerbation rate
quality of life
symptoms
use of rescue medication
safety and tolerability.

Trial Locations

Locations (2)

ATLANA Pharma; 🇺🇸 Cities in Colorado, Colorado, United States

ALTANA Pharma; 🇵🇪 Cities in Peru, Peru