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

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

This study has been completed.

Sponsored by:	ALTANA Pharma
Information provided by:	ALTANA Pharma
ClinicalTrials.gov Identifier:	NCT00062582

Purpose

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

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease COPD	Drug: Roflumilast	Phase III

MedlinePlus related topics:

COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for:

Roflumilast

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Official Title:	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)

Further study details as provided by ALTANA Pharma:

Primary Outcome Measures:

pulmonary function.

Secondary Outcome Measures:

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

Estimated Enrollment:	1000
Study Start Date:	June 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00062582

Show 37 Study Locations

Sponsors and Collaborators

ALTANA Pharma

Investigators


Principal Investigator:	Douglas S. Helmersen, Prof. Dr.	Peter Lougheed Center; 3500-26th Ave. NE, Calgary, Canada

More Information

Study ID Numbers:	BY217/M2-110
First Received:	June 9, 2003
Last Updated:	December 15, 2006
ClinicalTrials.gov Identifier:	NCT00062582
Health Authority:	United States: Food and Drug Administration

Keywords provided by ALTANA Pharma:

Roflumilast

Chronic Obstructive Pulmonary Disease

COPD

Study placed in the following topic categories:

Signs and Symptoms

Lung Diseases, Obstructive

Respiratory Tract Diseases

Lung Diseases

Signs and Symptoms, Respiratory

Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on November 30, 2008