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

Study Overview
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Brief Summary
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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).

Official Title
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A Prospective, Real-World, Interventional Study To Evaluate The Effect Of Mepolizumab On Achieving Clinical Remission In Participants With Severe Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: Mepolizumab
* Other: Spirometry


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: All Participants<br>All participants with clinical diagnosis of Severe asthma prescribed Mepolizumab as part of routine care. | Drug: Mepolizumab<br>* Mepolizumab will be prescribed based on physician decision.<br>* Other names: NUCALA;Other: Spirometry<br>* Lung function via spirometry will be collected.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage (%) of Participants Achieving 4-Component Clinical Remission | 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. | At month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annualized Rates of Clinically Significant Asthma Exacerbations (CSE) and CSE Leading to Hospitalization/ Emergency Room (ER) Visits | 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. | At month 12 | 
| Percentage of Participants Achieving Oral corticosteroids (OCS) Sparing Remission | 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. | At month 12 | 
| Percentage of Participants Achieving 3-Component Clinical Remission | 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. | At month 12 | 
| Mean Change from Baseline in Mini-Asthma Quality of Life Questionnaire (AQLQ) Overall Score | 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. | Baseline and at month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mepolizumab, Oral corticosteroids (OCS), Severe asthma, Eosinophilic phenotype, Asthma exacerbations, Clinical remission, NUCALA