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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  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




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