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Study In Subjects With COPD (Chronic Obstructive Pulmonary Disease)
This study has been completed.
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00103922
  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 III

MedlinePlus related topics: Bronchitis COPD (Chronic Obstructive Pulmonary Disease) Emphysema
Drug Information available for: Cilomilast
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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)

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

Responsible Party: GSK ( Study Director )
Study ID Numbers: CIL103657
Study First Received: February 17, 2005
Last Updated: October 13, 2008
ClinicalTrials.gov Identifier: NCT00103922  
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
smokers cough

Study placed in the following topic categories:
Pulmonary Emphysema
Emphysema
Lung Diseases, Obstructive
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Cough
Bronchitis
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:
Pathologic Processes
Bronchial Diseases

ClinicalTrials.gov processed this record on January 15, 2009