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

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

Primary Outcome Measures

Name	Time	Method
Main Objective: 1. Describe the proportion of patients that achieved clinical remission at 12 months, in the principal stratum of patients’ adherent to NUCALA;Secondary Objective: 1. Summarize the rate of clinically significant asthma exacerbations in patients over the follow-up period, in the principal stratum of patients’ adherent to NUCALA 2. Describe the proportion of patients that achieved OCS sparing and 3-component clinical remission at 12 months, in the principal stratum of patients’ adherent to NUCALA 3. Evaluate the change from baseline in HRQoL, in the principal stratum of patients’ adherent to NUCALA;Primary end point(s): 1. Endpoint: Achieving 4-component clinical remission Summary Measure: Proportion and 95% confidence interval of patients that achieved clinical remission at 12 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):1. • Clinically Significant Asthma Exacerbations (CSE) • CSE leading to hospitalization/Emergency room (ER) visits 2. • Achieving oral corticosteroids (OCS) sparing remission • Achieving 3-component clinical remission 3. Change in the 15-item mini-AQLQ overall score from baseline to 12 months