Does combination therapy increase adherence with inhaled corticosteroids and improve clinical outcomes in asthma?
Completed
- Conditions
- AsthmaRespiratory - Asthma
- Registration Number
- ACTRN12606000508572
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Doctor diagnosis of asthma, Currently prescribed inhaled corticosteroids (ICS), Steady dose of ICS for at least one month, No exacerbation in the previous month requiring a GP or hospital visit, No exacerbation in the run-in period.
Exclusion Criteria
History of clinically significant disease which may affect the outcome of the study, Currently prescribed combination therapy (inhaled corticosteroid and long acting beta agonist in combined inhaler), No known sensitivity to beta-agonists, salmeterol or any of its ingredients.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Adherence, defined as the proportion of medication (fluticasone propionate and salmeterol either in combination or separatetly) taken as directed[In the final six week period of the study.];2. Overuse of medication, defined as the mean number of extra doses taken per day[In the final six week period of the study.]
- Secondary Outcome Measures
Name Time Method 1. Adherence: defined as (i) the proportion of medication taken as directed in the first, second and third six week periods of the study and (ii) the proportion of patients who took >50%, >80% or >90% of their mediation as prescribed.[6 weeks, 12 weeks and 18 weeks];2. Overuse: defined as (i) percentage of days in which an extra dose was taken in each six week period, (ii) maximum number of puffs taken in any one day in each six week period and (iii) number of times 'dose dumping' occurred in each six week period.[6 weeks, 12 weeks and 18 weeks]