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.

First Received: June 9, 2003 Last Updated: December 15, 2006 History of Changes

Sponsor:	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

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)

Resource links provided by NLM:

Drug Information available for: Roflumilast

Further study details as provided by ALTANA Pharma:

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment:	1000
Study Start Date:	June 2003

Eligibility

Criteria

Main Inclusion Criteria:

Main Exclusion Criteria:

Contacts and Locations

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

Sponsors and Collaborators

ALTANA Pharma

Investigators

Principal Investigator:

Douglas S. Helmersen, Prof. Dr.

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

More Information

No publications provided

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

Keywords provided by ALTANA Pharma:

Roflumilast
Chronic Obstructive Pulmonary Disease
COPD

Additional relevant MeSH terms:

Signs and Symptoms
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Respiration Disorders
Signs and Symptoms, Respiratory
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on November 09, 2009