A cluster Randomised Controlled Trial of the effectiveness, usability and acceptability of a smart inhaler programme in asthma patients: the ACCEPTANCE study
- Conditions
- asthma10006436
- Registration Number
- NL-OMON52658
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 242
Age >= 18 years;
Doctor-diagnosed asthma (according to Dutch national primary care asthma
guidelines (NHG)) - route A and B; Self-reported asthma diagnosis (confirmed at
study end (T12) by GP) - route C;
Partially controlled or uncontrolled asthma (ACQ >= 0.75);
Use of Symbicort Turbuhaler maintenance therapy;
Being 'non-adherent' defined as an adherence rate (number of fully adherent
days / total number of days) of below 80% over the 3rd and 4th week of the
run-in period.
Use of SMART regimen (Symbicort Maintenance And Reliever Therapy) by taking
Symbicort as reliever in response to symptoms;
Change in inhaled corticosteroids dose in the 4 weeks prior to run-in period;
Use of systemic corticosteroids in the 4 weeks prior to run-in period;
Current use of biologics, (anti-IL-5 en anti-IgE);
Diagnosis of COPD or other significant respiratory diseases;
Malignancy with life expectancy < 1 year;
Pregnancy;
Inability to understand Dutch.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method