Severe Asthma with comorbid BronchiEctasis: response to BIOlogical therapy
Recruiting
- Conditions
- Severe asthma and bronchiectasis
- Registration Number
- NL-OMON20373
- Lead Sponsor
- o
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Dutch adult (>18 yr) included in RAPSODI
- Received at least 1 dose of one of the anti-IL-5 treatments (mepolizumab, reslizumab, benralizumab).
- Anti- IL-5 treatment was started before 1.9.2020
- Data on presence or absence of BE (reported comorbidity and CT-scan) are available
Exclusion Criteria
Not applicable
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1a. Daily OCS dose<br>Change in daily OCS dose between initiation (= the day of starting anti IL-5) and 1 year after start of anti-IL-5 therapy in OCS dependent patients with severe asthma and comorbid BE.<br>1b. Exacerbation rate<br>Change in annualized exacerbation rate between 1 year before and 1 year after start of anti-IL-5 therapy in non-OCS dependent patients. Defined as: Percentage of patients with an exacerbation rate 0-1/= 2/>5 exacerbations/yr, 1 year before and 1 year after start of anti-IL-5 therapy. <br>2. Cumulative OCS dose<br>Change in cumulative OCS use between 1 year before and 1 year after start of anti-IL-5 therapy in all patients with SEA and BE will be calculated as the sum of the amount of issued tablets multiplied by the strength (mg per tablet) in months -12 to 0 and months 0 to 12.<br> <br>
- Secondary Outcome Measures
Name Time Method Patient reported outcome measures (PROMs)<br>-6-item Asthma Control Questionnaire score (ACQ-6) (22)<br><br>-Asthma Quality of life questionnaire (AQLQ) (23)<br>Asthma-related health care use<br>