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

Phase 4

Active, not recruiting

• Conditions: severe asthma
• Interventions: Drug: Mepolizumab; Other: Spirometry

• Registration Number: 2023-509026-21-00
• Lead Sponsor: Glaxosmithkline Research & Development Limited

Brief Summary

1. Describe the proportion of patients that achieved clinical remission at 12 months, in the principal stratum of patients’ adherent to NUCALA

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-06
• Study First Submitted QC: 2023-09-15
• Study First Posted: 2023-09-18
• Study Start: 2024-03-20
• Primary Completion: 2025-01-31
• Status Verified: 2025-06
• Last Update Submitted: 2025-07-02
• Last Update Posted: 2025-07-03
• Study Completion: 2028-06-14

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Not specified
• Target Recruitment: 170

Inclusion Criteria

1. Adults aged 18 years or over

2. Participant has a confirmed asthma diagnosis with physician decision to initiate treatment with NUCALA

3. Participants with ≥60% predicted FEV1 and ≤4 exacerbations per year, as confirmed by the physician.

4. 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. Any NUCALA use in the 6 months prior to enrollment.

3. Participants currently on maintenance oral corticosteroids (mOCS) or intramuscular corticosteroids.

4. Participants using omalizumab, reslizumab, dupilumab, tezepelumab, or benralizumab within the 6 months prior to enrollment.

5. Participating in an interventional study with a treatment intervention.

6. Other clinically significant respiratory conditions (e.g., bronchiectasis, pulmonary fibrosis).

7. Current smokers.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Mepolizumab	Participants with a clinical diagnosis of Severe asthma prescribed Mepolizumab as part of routine care.
Group 1	Spirometry	Participants with a clinical diagnosis of Severe asthma prescribed Mepolizumab as part of routine care.

Primary Outcome Measures

Name	Time	Method
1. Endpoint: Achieving 4-component clinical remission Summary Measure: Proportion and 95% confidence interval of patients that achieved clinical remission at 12 months		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
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		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

Trial Locations

Locations (1)

GSK Investigational Site; 🇪🇸 Valencia, Spain