Asthma
Conditions
Keywords
Total asthma control, airway hyper-responsiveness, adult, Asthma
Brief 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.
Detailed description
A multi-centre, randomised, double blind, stratified, and parallel group study to evaluate whether a treatment strategy based on aiming for 'Total control' results in better airway hyper-responsiveness than a treatment strategy based on maintaining the treatment level at which 'Well-controlled' asthma was achieved.
Interventions
DRUGSalmeterol/fluticasone propionate combination
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* History of asthma of at least 6 months. * Subjects who have received fluticasone propionate at a dose of 100 mcg bd to 250 mcg bd or equivalent with or without a long acting beta2-agonist for at least 4 weeks before the start of the run-in period, at a constant dose. * Subjects who are able to understand and complete an electronic diary card.
Exclusion criteria
* Subjects who have been hospitalized for their asthma within 4 weeks of study entry. * Subjects who had an acute upper respiratory tract infection within 4 weeks or a lower respiratory tract infection within 4 weeks prior to study entry. * Subjects who received oral, parental or depot corticosteroids within 4 weeks prior to study entry. * Subjects who have a known respiratory disorder other than asthma and/or systemic/thoracic abnormalities which influence normal lung function. * Subjects who have more than 5 pack years. * Subjects who currently smoke.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in PC20 methacholine (as a measure of airway hyper-responsiveness) following 24 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of 'Totally-controlled' and Well-controlled patients at the end of the run-in and treatment period according to the GOAL criteria. | — |
Countries
Belgium, Estonia, Finland, France, Germany, Italy, Latvia, Netherlands, Spain, Sweden
Outcome results
None listed