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Study In Subjects With COPD (Chronic Obstructive Pulmonary Disease)

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00103922
First received: February 17, 2005
Last updated: October 1, 2010
Last verified: October 2010
History of Changes
  Purpose

This study was designed to determine if the investigational drug is effective and safe in individuals with COPD (chronic pulmonary disease)


Condition Intervention Phase
Emphysema
Bronchitis
 Drug: cilomilast
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, 24-week, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety and Tolerability of ARIFLO® (15mg BID) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • measure of lung function and quality of life in patients with COPD

Secondary Outcome Measures:
  • exacerbations in patients with COPD

Estimated Enrollment: 600
Study Start Date: November 2004
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: cilomilast
    Other Name: cilomilast
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Diagnosis of COPD and a history of cigarette smoking.

Exclusion criteria:

  • Significant heart or lung disease not associated with COPD.
  • Significant stomach or intestinal disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00103922

  Show 112 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00103922     History of Changes
Other Study ID Numbers: CIL103657
Study First Received: February 17, 2005
Last Updated: October 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
smokers cough

Additional relevant MeSH terms:
Bronchitis
Emphysema
Pulmonary Emphysema
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Diseases
 Respiratory Tract Infections
Pathologic Processes
Cilomilast
Phosphodiesterase 4 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013