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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:
ClinicalTrials.gov Identifier:
NCT00062582
First Posted: June 10, 2003
Last Update Posted: November 23, 2016
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.
Information provided by (Responsible Party):
AstraZeneca
June 9, 2003
June 10, 2003
November 23, 2016
June 2003
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pulmonary function.
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Complete list of historical versions of study NCT00062582 on ClinicalTrials.gov Archive Site
  • exacerbation rate
  • quality of life
  • symptoms
  • use of rescue medication
  • safety and tolerability.
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Effect of Roflumilast on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BY217/M2-110)
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)
The aim of the study is to compare the effect of roflumilast and placebo on the lung function in patients with COPD.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Chronic Obstructive Pulmonary Disease
  • COPD
Drug: Roflumilast
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
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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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Canada,   Colombia,   Mexico,   Peru,   United States
 
 
NCT00062582
BY217/M2-110
Not Provided
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AstraZeneca
AstraZeneca
Not Provided
Study Director: AstraZeneca AstraZeneca AstraZeneca
AstraZeneca
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP