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:

MedlinePlus related topics: COPD Lung Diseases

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)

Eligibility


Ages Eligible for Study:	40 Years and older (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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:


Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Bronchitis Emphysema Respiratory Tract Diseases Bronchial Diseases	Respiratory Tract Infections Pathologic Processes Cilomilast Phosphodiesterase 4 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 28, 2016

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