REIMAGINE - Real World EvaluatIon of Mepolizumab in Severe Asthma achievinG on Treatment clinIcal remissioN, a prospEctive Study

Phase 4

Not yet recruiting

• Conditions: Asthma
• Interventions: Drug: Mepolizumab; Other: Spirometry

• Registration Number: NCT06041386
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This is a prospective, real-world, single arm, global, multi-centre study to evaluate the effect of timely treatment with mepolizumab (NUCALA) to achieve clinical remission in adult participants with severe asthma with an eosinophilic phenotype (SA-EP).

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-06
• Study First Submitted QC: 2023-09-15
• Last Update Submitted: 2023-09-15
• Study First Posted: 2023-09-18
• Last Update Posted: 2023-09-18
• Study Start: 2023-11-16
• Primary Completion: 2026-07-27
• Study Completion: 2026-07-27

Recruitment & Eligibility

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

Inclusion Criteria

• Participant has a confirmed asthma diagnosis and has been prescribed NUCALA by their physician for the treatment of asthma, as per local label. NUCALA can be initiated up to 7 days prior to study enrollment.
• No NUCALA use in the 6 months prior to enrollment.
• Participants with greater than or equal to (≥)60 percentage (%) predicted forced expiratory volume in 1 second (FEV1) and less than or equal to (≤)4 exacerbations per year, as confirmed by the physician.
• Other local prescription criteria of NUCALA not described above at NUCALA initiation (e.g., local reimbursement criteria).
• Written informed consent.

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Exclusion Criteria

• Investigator concerns about participant's willingness to adhere to biologic treatment for any reason (e.g., cost, behavior, difficulty with access to healthcare).
• Participants currently on maintenance OCS.
• Participants using omalizumab, reslizumab, dupilumab, tezepelumab, or benralizumab within the 6 months prior to enrollment.
• Participants participating in an interventional study with a treatment intervention.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Participants	Mepolizumab	All participants with clinical diagnosis of Severe asthma prescribed Mepolizumab as part of routine care.
All Participants	Spirometry	All participants with clinical diagnosis of Severe asthma prescribed Mepolizumab as part of routine care.

Primary Outcome Measures

Name	Time	Method
Percentage (%) of Participants Achieving 4-Component Clinical Remission	At month 12	4-component clinical remission is defined as (a) No clinically significant asthma exacerbations (b) No OCS use for asthma (c) Well controlled asthma based on an Asthma Control Test (ACT) (d) No clinically significant deterioration of lung function.

Secondary Outcome Measures

Name	Time	Method
Annualized Rates of Clinically Significant Asthma Exacerbations (CSE) and CSE Leading to Hospitalization/ Emergency Room (ER) Visits	At month 12	CSE is defined as a deterioration in asthma requiring (1) the initiation of systemic corticosteroids and/or (2) an ER visit and/or hospital admission.
Percentage of Participants Achieving 3-Component Clinical Remission	At month 12	3-component clinical remission is defined as (a) No clinically significant asthma exacerbations (b) No OCS use for asthma (c) Well controlled asthma based on an ACT.
Percentage of Participants Achieving Oral corticosteroids (OCS) Sparing Remission	At month 12	OCS sparing is defined as (a) No clinically significant asthma exacerbations during the period of interest (b) No OCS use for asthma at the time point of interest.
Mean Change from Baseline in Mini-Asthma Quality of Life Questionnaire (AQLQ) Overall Score	Baseline and at month 12	The mini-AQLQ overall score is a reduced version of the AQLQ which includes 15 items. The minimally clinically important difference (MCID) is 0.5. The response options for each item are on an equidistant scale of 7 points, where 1 corresponds to the maximum disability and 7 to the absence of disability.