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.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: June 9, 2003
Last updated: May 4, 2012
Last verified: January 2012
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
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:

Further study details as provided by Takeda:

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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 37 Study Locations
Sponsors and Collaborators
Principal Investigator: Douglas S. Helmersen, Prof. Dr. Peter Lougheed Center; 3500-26th Ave. NE, Calgary, Canada
  More Information

Responsible Party: Takeda
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:
Chronic Obstructive Pulmonary Disease

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Signs and Symptoms, Respiratory
Respiratory Tract Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 26, 2016