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Effect of Roflumilast on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BY217/M2-110)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00062582
Recruitment Status : Completed
First Posted : June 10, 2003
Last Update Posted : November 23, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The aim of the study is to compare the effect of roflumilast and placebo on the lung function in patients with COPD.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease COPD Drug: Roflumilast Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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)
Study Start Date : June 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
Drug Information available for: Roflumilast
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. pulmonary function.

Secondary Outcome Measures :
  1. exacerbation rate
  2. quality of life
  3. symptoms
  4. use of rescue medication
  5. safety and tolerability.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00062582


  Show 37 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca AstraZeneca AstraZeneca
More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00062582     History of Changes
Other Study ID Numbers: BY217/M2-110
First Posted: June 10, 2003    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: September 2016

Keywords provided by AstraZeneca:
Roflumilast
Chronic Obstructive Pulmonary Disease
COPD

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