Airway Hyper-responsiveness Study In Asthma Using Salmeterol/Fluticasone Propionate Combination Product
Status:
Completed
Trial end date:
2007-07-01
Target enrollment:
Participant gender:
Summary
This double-blind, stratified, parallel group study is to determine whether aiming for 'Total
control' results in better airway hyper-responsiveness than maintaining the treatment level
at which 'Well-controlled' asthma was achieved. The primary endpoint is the mean change in
PC20 methacholine. Well controlled subjects (as assessed after a 12 week run-in period) will
enter a 24 week treatment period during which they will record PEF(Peak Expiratory Flow),
symptoms, rescue beta2-agonist use over 24 hours, night time awakenings, asthma
exacerbations, emergency visits due to asthma and Adverse Events. At every visit lung
function measurements and airway hyper-responsiveness will be measured.