Status:
COMPLETED
SERETIDE Plus Tiotropium Versus Individual Components
Lead Sponsor:
GlaxoSmithKline
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
This study was designed to evaluate the effects on lung function of a combination of SERETIDE 50/500mcg twice daily plus tiotropium bromide 18mcg once daily compared with the individual treatments (ti...
Detailed Description
A randomised, double-blind, double dummy, 3 way cross-over study evaluating the effects of SERETIDE™ 50/500mcg twice daily plus tiotropium bromide 18mcg once daily compared with the individual treatme...
Eligibility Criteria
Inclusion
- Has an established clinical history of COPD as defined as per the GOLD definition.
- Post-bronchodilator FEV1 of \>30% to 75% of predicted normal at Visit 1, a post-bronchodilator FEV1 / FVC ratio = 70%.
- Current or ex-smoker with a smoking history of \> 10 pack-years.
Exclusion
- Has unstable COPD (Chronic Obstructive Pulmonary Disease).
- Has a current medical diagnosis of asthma and/or allergic rhinitis or know respiratory disorders (lung cancer, sarcoidosis, tuberculosis or lung fibrosis) Requires regular (daily) or long term oxygen therapy (LTOT). (LTOT is defined as \> 12 hours oxygen use per day).
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00325169
Start Date
December 1 2005
End Date
August 1 2006
Last Update
October 21 2016
Active Locations (5)
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1
GSK Investigational Site
Ghent, Belgium, 9000
2
GSK Investigational Site
Southampton, Hampshire, United Kingdom, SO16 6YD
3
GSK Investigational Site
Manchester, Lancashire, United Kingdom, M23 9LT
4
GSK Investigational Site
London, United Kingdom, NW3 2QG