Study In Subjects With COPD (Chronic Obstructive Pulmonary Disease) - Full Text View

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

ChemIDplus related topics:

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
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 October 17, 2008