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 on June 9, 2003. Last Updated on January 18, 2012 History of Changes

Sponsor:	ALTANA Pharma
Information provided by (Responsible Party):	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:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

U.S. FDA Resources

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

Responsible Party:	ALTANA Pharma
ClinicalTrials.gov Identifier:	NCT00062582 History of Changes
Other Study ID Numbers:	BY217/M2-110
Study First Received:	June 9, 2003
Last Updated:	January 18, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by ALTANA Pharma:

Roflumilast
Chronic Obstructive Pulmonary Disease
COPD

Additional relevant MeSH terms:

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

Lung Diseases, Obstructive
Respiratory Tract Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012