Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

February 17, 2005
October 1, 2010
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Emphysema
  • Bronchitis
Drug: cilomilast
Other Name: cilomilast
Not Provided
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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00103922
CIL103657
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
October 2010

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