Biomarkers of asthma remission after dupilumab treatment
- Conditions
- Severe asthmaRespiratory
- Registration Number
- ISRCTN68147929
- Lead Sponsor
- niversity of Leicester
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 150
1. Adults (=18 years old)
2. Clinical decision to initiate dupilumab for severe asthma after meeting licensing, local and national guidelines.
3. Be able to give valid written consent. Participants should have reasonable understanding of the English language (assessed by the research team)
4. Be compliant with study procedures and study visits.
1. Known hypersensitivity to the active substance of dupilumab or any of the excipients
2. Participation in an interventional clinical trial within 3 months of visit 1 or receipt of any investigational medicinal product within 3 months or 5 half-lives. Participation in other observational studies is acceptable if, in the view of the investigator, it will not impact the study outcomes.
3. Other clinically significant medical disease or uncontrolled concomitant disease that is likely, in the opinion of the investigator, to require a change in therapy or impact the ability to participate in the study.
4. Subjects on regular oral corticosteroids (OCS) and whereby the administration of dupilumab for OCS reduction will not be included in the study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome measures are assessed at 1 year:<br>1. Asthma control measured using the Asthma Control Questionnaire 5 Questions (ACQ5) <1.5<br>2. Lung function post-bronchodilator (post-BD) Forced Expiratory Volume in 1 Second (FEV1) percent predicted measured using spirometry <br>3. Exacerbations history measured using the patient's medical notes<br>
- Secondary Outcome Measures
Name Time Method