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

Tracking Information

First Received Date ^ICMJE

June 9, 2003

Last Updated Date

December 15, 2006

Start Date ^ICMJE

June 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

pulmonary function.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00062582 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A 24 Week, Placebo-Controlled, Randomized, Parallel Group Study Comparing Roflumilast 500 Mcg Daily vs Placebo on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Condition ^ICMJE

Chronic Obstructive Pulmonary Disease
COPD

Intervention ^ICMJE

Drug: Roflumilast

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1000

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Main 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Canada, Colombia, Mexico, Peru

Administrative Information

NCT ID ^ICMJE

NCT00062582

Responsible Party

Study ID Numbers ^ICMJE

BY217/M2-110

Study Sponsor ^ICMJE

ALTANA Pharma

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Douglas S. Helmersen, Prof. Dr.

Peter Lougheed Center; 3500-26th Ave. NE, Calgary, Canada

Information Provided By

ALTANA Pharma

Verification Date

December 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP