Clinical Evaluation Of GW815SF For Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00269126
First received: December 21, 2005
Last updated: April 11, 2013
Last verified: May 2012

December 21, 2005
April 11, 2013
February 2005
August 2005   (final data collection date for primary outcome measure)
Change from baseline in pre-dose FEV1 at 4 weeks after starting medication of GW815SF 50/250µg
Same as current
Complete list of historical versions of study NCT00269126 on ClinicalTrials.gov Archive Site
  • Change in morning PEF
  • Changes in pre-dose FVC, V50, V25
  • Use of rescue medication
  • Changes in symptom scores
Same as current
Not Provided
Not Provided
 
Clinical Evaluation Of GW815SF For Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema)
See Detailed Description

This study compares the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease). This study will last up to 18 weeks, and subjects will visit the clinic 5 times. Subjects will be given breathing tests, and will record their breathing symptoms daily on diary cards.

Clinical Evaluation of GW815SF for Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema) "Assessment of the Effect of Addition of Fluticasone Dipropionate to Salmeterol Xinafoate 50µg after Switching under Double-blinded conditions to GW815SF 50/250µg in Chronic Obstructive Pulmonary Disease

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
  • Drug: fluticasone propionate/salmeterol combination DISKUS
  • Drug: salmeterol xinafoate
    Other Names:
    • fluticasone propionate/salmeterol combination DISKUS
    • salmeterol xinafoate
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
150
August 2005
August 2005   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Diagnosis of COPD.

Exclusion criteria:

  • Diagnosis of asthma or an uncontrolled medical condition or respiratory disorder other than COPD.
  • Other inclusion and exclusion criteria will be evaluated at the first study visit.
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan,   Spain
 
NCT00269126
SCO100646
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
May 2012

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