REIMAGINE – Real-world EvaluatIon of Mepolizumab in severe Asthma achievinG on treatment clinIcal remissioN, a prospEctive study.

Phase 1

Recruiting

• Conditions: severe asthma; MedDRA version: 21.1Level: LLTClassification code: 10068462Term: Eosinophilic asthma Class: 10038738; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: CTIS2023-509026-21-00
• Lead Sponsor: Glaxosmithkline Research & Development Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-24
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 336

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified