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Study In Subjects With COPD (Chronic Obstructive Pulmonary Disease)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00103922
First Posted: February 18, 2005
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
February 17, 2005
February 18, 2005
October 12, 2017
November 2004
January 2007   (Final data collection date for primary outcome measure)
measure of lung function and quality of life in patients with COPD
Not Provided
Complete list of historical versions of study NCT00103922 on ClinicalTrials.gov Archive Site
exacerbations in patients with COPD
Not Provided
Not Provided
Not Provided
 
Study In Subjects With COPD (Chronic Obstructive Pulmonary Disease)
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)
This study was designed to determine if the investigational drug is effective and safe in individuals with COPD (chronic pulmonary disease)
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
Drug: cilomilast
Experimental: Arm 1
Intervention: Drug: cilomilast
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
January 2007
January 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00103922
CIL103657
No
Not Provided
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.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP