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
ClinicalTrials.gov Identifier:
NCT00062582
First received: June 9, 2003
Last updated: May 4, 2012
Last verified: January 2012

June 9, 2003
May 4, 2012
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.

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Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Canada,   Colombia,   Mexico,   Peru
 
NCT00062582
BY217/M2-110
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Takeda
Takeda
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Principal Investigator: Douglas S. Helmersen, Prof. Dr. Peter Lougheed Center; 3500-26th Ave. NE, Calgary, Canada
Takeda
January 2012

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