Study In Subjects With COPD (Chronic Obstructive Pulmonary Disease)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00103922

First received: February 17, 2005

Last updated: October 26, 2016

Last verified: October 2016

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
Pulmonary Disease, Chronic Obstructive	Drug: cilomilast	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) 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


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)

Arms	Assigned Interventions
Experimental: Arm 1	Drug: cilomilast

Eligibility


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

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00103922

Show 115 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Additional Information:

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