A prospective, real-world, interventional study to evaluate the effect of mepolizumab on achieving clinical remission in participants with severe asthma.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509026-21-00

Acronym

219871

Enrollment

170

Registered

2024-05-14

Start date

2024-06-03

Completion date

Unknown

Last updated

2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

severe asthma

Brief summary

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

Detailed description

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

Interventions

DRUGNucala 100 mg solution for injection in pre-filled pen

DRUGNucala 100 mg solution for injection in pre-filled syringe

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Countries

Belgium, France, Germany, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026