Residual Exacerbations With Mepolizumab

Recruiting

• Conditions: Asthma
• Interventions: Drug: Mepolizumab

• Registration Number: NCT04578171
• Lead Sponsor: Laval University

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2020-09-28
• Study First Submitted QC: 2020-10-02
• Study First Posted: 2020-10-08
• Study Start: 2021-07-06
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-10
• Primary Completion: 2027-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study population	Mepolizumab	Subjects with severe asthma treated with mepolizumab

Primary Outcome Measures

Name	Time	Method
Proportion of eosinophilic vs non-eosinophilic remaining exacerbation during the treatment period	Between baseline and month 24	Eosinophilic exacerbation defined as \>=3% sputum eosinophils. Ratio of eosinophilic vs non eosinophilic asthma exacerbation

Secondary Outcome Measures

Name	Time	Method
Change from baseline in post-bronchodilator forced expiratory volume in one second (FEV1) at 24 months	Baseline and month 24	Value of FEV1 measured after inhalation of 400ug of salbutamol. Recorded in Li. (Month 24 FEV1 value - baseline FEV1 value)
Change from baseline in post-bronchodilator FEV1/forced vital capacity (FVC) ratio at 24 months	Baseline and month 24	Value of FEV1/FVC measured after inhalation of 400 ug of salbutamol. (Month 24 value - baseline value)
Change from baseline in percentage of sputum neutrophils	Baseline and month 24	Determined from induced sputum analysis. (Month 24 sputum neutrophil percentages - baseline sputum neutrophil percentages).
Change from baseline in asthma control on the Asthma Control Questionnaire (ACQ-5) at 24 months	Baseline and month 24	The ACQ-5 is a validated, self-reported questionnaire assessing asthma control over the last week. Possible scores range from 0 (complete control) to 5 (no control). Change = (Month 24 score - baseline score)
Change from baseline in fraction of exhaled nitric oxide (FeNO) levels at 24 months	Baseline and month 24	Recorded in ppb using the mean of two reproducible measurements. (Month 24 value - baseline value)
Change from baseline in percentage of sputum eosinophils at 24 months	Baseline and month 24	Determined from induced sputum analysis. (Month 24 sputum eosinophil percentages - baseline sputum eosinophil percentages)

Trial Locations

Locations (1)

Institut universitaire de cardiologie et de pneumologie de Québec; 🇨🇦 Québec, Quebec, Canada