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
  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:


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 April 22, 2014