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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.
Sponsor:
Information provided by (Responsible Party):
Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:
NCT00062582
First received: June 9, 2003
Last updated: May 4, 2012
Last verified: January 2012
History of Changes
  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 3

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 Takeda Global Research & Development Center, Inc.:

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
Takeda Global Research & Development Center, Inc.
Investigators
Principal Investigator: Douglas S. Helmersen, Prof. Dr. Peter Lougheed Center; 3500-26th Ave. NE, Calgary, Canada
  More Information

No publications provided

Responsible Party: Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00062582     History of Changes
Other Study ID Numbers: BY217/M2-110
Study First Received: June 9, 2003
Last Updated: May 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Takeda Global Research & Development Center, Inc.:
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 May 22, 2013