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

Glaxosmithkline Research & Development Limited1 site in 1 country170 target enrollmentMarch 20, 2024

DrugsNucala 100 mg solution for injection in pre-filled syringe Nucala 100 mg solution for injection in pre-filled pen, Nucala 100 mg solution for injection in pre-filled syringe, Nucala 100 mg solution for injection in pre-filled pen, Nucala 100 mg solution for injection in pre-filled syringe, Nucala 100 mg solution for injection in pre-filled pen, Nucala 100 mg solution for injection in pre-filled syringe Nucala 100 mg solution for injection in pre-filled pen

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Not specified
Sponsor: Glaxosmithkline Research & Development Limited
Enrollment: 170
Locations: 1
Primary Endpoint: 1. Endpoint: Achieving 4-component clinical remission Summary Measure: Proportion and 95% confidence interval of patients that achieved clinical remission at 12 months
Status: Active, Not Recruiting
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

euclinicaltrials.eu

Start Date

March 20, 2024

End Date

June 14, 2028

Last Updated

9 months ago

Study Type

Interventional

Investigators

Sponsor

Glaxosmithkline Research & Development Limited

Responsible Party

Principal Investigator

EU GSK Clinical Trials Call Center

Scientific

Glaxosmithkline Research & Development Limited

Eligibility Criteria

Inclusion Criteria

•Adults aged 18 years or over
•Participant has a confirmed asthma diagnosis with physician decision to initiate treatment with NUCALA
•Participants with ≥60% predicted FEV1 and ≤4 exacerbations per year, as confirmed by the physician.
•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)
•Any NUCALA use in the 6 months prior to enrollment.
•Participants currently on maintenance oral corticosteroids (mOCS) or intramuscular corticosteroids.
•Participants using omalizumab, reslizumab, dupilumab, tezepelumab, or benralizumab within the 6 months prior to enrollment.
•Participating in an interventional study with a treatment intervention.
•Other clinically significant respiratory conditions (e.g., bronchiectasis, pulmonary fibrosis).
•Current smokers.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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