Study In Subjects With COPD (Chronic Obstructive Pulmonary Disease)
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ClinicalTrials.gov Identifier: NCT00103922 |
Recruitment Status
:
Completed
First Posted
: February 18, 2005
Last Update Posted
: October 28, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pulmonary Disease, Chronic Obstructive | Drug: cilomilast | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 600 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (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) |
Study Start Date : | November 2004 |
Actual Primary Completion Date : | January 2007 |
Actual Study Completion Date : | January 2007 |
Arm | Intervention/treatment |
---|---|
Experimental: Arm 1 | Drug: cilomilast |
- measure of lung function and quality of life in patients with COPD
- exacerbations in patients with COPD

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Ages Eligible for Study: | 40 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00103922

Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Additional Information:
Study Data/Documents: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00103922 History of Changes |
Other Study ID Numbers: |
CIL103657 |
First Posted: | February 18, 2005 Key Record Dates |
Last Update Posted: | October 28, 2016 |
Last Verified: | October 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site. |
Keywords provided by GlaxoSmithKline:
smokers cough |
Additional relevant MeSH terms:
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Chronic Disease Respiratory Tract Diseases Disease Attributes |
Pathologic Processes Cilomilast Phosphodiesterase 4 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |