Residual Exacerbations With Mepolizumab

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-06

Study Completion Date

2028-01-31

Brief Summary

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This will be a two-year prospective study to characterize the nature of the remaining asthma exacerbations in patients treated with mepolizumab. Participants will be assessed every six months from pre- until two years of treatment in addition to whenever they experience an exacerbation of asthma during the study period. During these visits, various clinical, physiological and inflammatory outcomes will be assessed.

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Detailed Description

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Before initiation of mepolizumab, a recording of patient's demographics, clinical, physiological and inflammatory features will be recorded. All subjects will be reassessed for the above measures at 6, 12, 18 and 24 months.

In addition to the above visits, patients will be assessed every time they experience either moderate or severe exacerbation of asthma over the treatment period.

Based on the percentage of sputum eosinophils and neutrophils, the type of inflammatory exacerbation will be determined

Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study population

Subjects with severe asthma treated with mepolizumab

Mepolizumab

Intervention Type DRUG

100 mg subcutaneous injections every four weeks

Interventions

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Mepolizumab

100 mg subcutaneous injections every four weeks

Intervention Type DRUG

Other Intervention Names

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nucala

Eligibility Criteria

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Inclusion Criteria

* With a proven diagnosis of severe asthma as defined by the Canadian Thoracic Society
* Eligible for mepolizumab treatment
* Able and willing to sign the informed consent form

Exclusion Criteria

* Any respiratory disease apart from asthma
* Confounding comorbidities sur as eosinophilic granulomatosis with polyangiitis (EGPA) or hypereosinophilic syndrome

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No