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Clinical Trials/CTIS2023-509026-21-00
CTIS2023-509026-21-00
Recruiting
Phase 1

A prospective, real-world, interventional study to evaluate the effect of mepolizumab on achieving clinical remission in participants with severe asthma. - 219871

Glaxosmithkline Research & Development Limited0 sites336 target enrollmentJanuary 24, 2024

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
severe asthma
Sponsor
Glaxosmithkline Research & Development Limited
Enrollment
336
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 24, 2024
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\. Adults aged 18 years or over 2\. Participant has a confirmed asthma diagnosis and has been prescribed NUCALA by their physician for the treatment of asthma, as per local label. 3\. No NUCALA use in the 6 months prior to enrollment (unless as stated in inclusion criteria 2\) 4\. Participants with \=60% predicted FEV1 (Forced expiratory volume in 1 second) and \=4 exacerbations per year, as confirmed by the physician 5\. Other local prescription criteria of NUCALA not described above at NUCALA initiation (e.g., local reimbursement criteria) 6\. 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\. Participants currently on maintenance oral corticosteroids (mOCS) or intramuscular corticosteroids 3\. Participants using omalizumab, reslizumab, dupilumab, tezepelumab, or benralizumab within the 6 months prior to enrollment 4\. Participating in an interventional study with a treatment intervention 5\. Other clinically significant respiratory conditions (e.g., bronchiectasis, pulmonary fibrosis) 6\. Current smokers

Outcomes

Primary Outcomes

Not specified

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