NL-OMON52658
Completed
Phase 4
A cluster Randomised Controlled Trial of the effectiveness, usability and acceptability of a smart inhaler programme in asthma patients: the ACCEPTANCE study - ACCEPTANCE study
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- eids Universitair Medisch Centrum
- Enrollment
- 242
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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;
- •Inability to understand Dutch.
Outcomes
Primary Outcomes
Not specified
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