CTIS2023-509026-21-00
Recruiting
Phase 1
A prospective, real-world, interventional study to evaluate the effect of mepolizumab on achieving clinical remission in participants with severe asthma. - 219871
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- severe asthma
- Sponsor
- Glaxosmithkline Research & Development Limited
- Enrollment
- 336
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adults aged 18 years or over 2\. Participant has a confirmed asthma diagnosis and has been prescribed NUCALA by their physician for the treatment of asthma, as per local label. 3\. No NUCALA use in the 6 months prior to enrollment (unless as stated in inclusion criteria 2\) 4\. Participants with \=60% predicted FEV1 (Forced expiratory volume in 1 second) and \=4 exacerbations per year, as confirmed by the physician 5\. Other local prescription criteria of NUCALA not described above at NUCALA initiation (e.g., local reimbursement criteria) 6\. Written informed consent
Exclusion Criteria
- •1\. Investigator concerns about participant’s willingness to adhere to biologic treatment for any reason (e.g., cost, behavior, difficulty with access to healthcare) 2\. Participants currently on maintenance oral corticosteroids (mOCS) or intramuscular corticosteroids 3\. Participants using omalizumab, reslizumab, dupilumab, tezepelumab, or benralizumab within the 6 months prior to enrollment 4\. Participating in an interventional study with a treatment intervention 5\. Other clinically significant respiratory conditions (e.g., bronchiectasis, pulmonary fibrosis) 6\. Current smokers
Outcomes
Primary Outcomes
Not specified
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