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GW815SF For Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00269087
First received: December 21, 2005
Last updated: May 22, 2014
Last verified: May 2014

December 21, 2005
May 22, 2014
January 2005
October 2006   (final data collection date for primary outcome measure)
All AEs occurring in the period from the start of the treatment period until the end of follow-up period will be classified by the body system, and the nature, incidence, and time of onset and severity of AEs will be assessed. [ Time Frame: throughout study ]
All AEs occurring in the period from the start of the treatment period until the end of follow-up period will be classified by the body system, and the nature, incidence, and time of onset and severity of AEs will be assessed.
Complete list of historical versions of study NCT00269087 on ClinicalTrials.gov Archive Site
  • Laboratory tests [ Time Frame: throughout study ]
  • 12-lead ECG [ Time Frame: throughout study ]
  • Physical examinations [ Time Frame: throughout study ]
  • Oropharyngeal examination [ Time Frame: throughout study ]
  • Change in morning PEF, changes in pre-dose FVC, V50 and V25 [ Time Frame: throughout study ]
  • Use of rescue medication [ Time Frame: throughout study ]
  • Changes in symptom scores [ Time Frame: throughout study ]
Laboratory tests 12-lead ECG Physical examinations Body weight Oropharyngeal examination Change in morning PEF, changes in pre-dose FVC, V50 and V25 Use of rescue medication Changes in symptom scores
Not Provided
Not Provided
 
GW815SF For Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema)
Clinical Evaluation of GW815SF for Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema)" A Long-term Treatment Study of GW815SF50/500µg in Chronic Obstructive Pulmonary Disease -

This study evaluates the safety of medicine on COPD (Chronic Obstructive Pulmonary Disease). This study will last up to 56 weeks, and subjects will visit the clinic 16 times. Subjects will be given breathing tests, and will record their breathing symptoms daily on diary cards.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
Drug: fluticasone propionate/salmeterol combination DISKUS
Other Name: fluticasone propionate/salmeterol combination DISKUS
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
122
October 2006
October 2006   (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
 
NCT00269087
SCO100648
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
May 2014

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