Residual Exacerbations With Mepolizumab

Type and Mechanisms of Residual Asthma Exacerbations in Patients Treated With Mepolizumab

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma
• Intervention / Treatment: Drug: Mepolizumab

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 Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Marie-Eve Boulay, MSc; Phone Number: 2617 4186568711; Email: marie-eve.boulay@criucpq.ulaval.ca

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G6K 1L8
      • Recruiting
      • Institut universitaire de Cardiologie et de Pneumologie de Quebec
      • Contact: Andréanne Côté, MD-MSc; Phone Number: 4186564747; Email: andreanne.cote@criucpq.ulaval.ca
      • Contact: Marie-Eve Boulay; Phone Number: Côté 4186568711; Email: marie-eve.boulay@criucpq.ulaval.ca
      • Principal Investigator: Andréanne Côté, MD-MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with severe asthma treated with mepolizumab at the IUCPQ-UL a tertiary care center from the Quebec city area.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study population; Subjects with severe asthma treated with mepolizumab	Drug: Mepolizumab; 100 mg subcutaneous injections every four weeks; Other Names: nucala

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in asthma control on the Asthma Control Questionnaire (ACQ-5) at 24 months	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)	Baseline and month 24
Change from baseline in post-bronchodilator forced expiratory volume in one second (FEV1) at 24 months	Value of FEV1 measured after inhalation of 400ug of salbutamol. Recorded in Li. (Month 24 FEV1 value - baseline FEV1 value)	Baseline and month 24
Change from baseline in post-bronchodilator FEV1/forced vital capacity (FVC) ratio at 24 months	Value of FEV1/FVC measured after inhalation of 400 ug of salbutamol. (Month 24 value - baseline value)	Baseline and month 24
Change from baseline in fraction of exhaled nitric oxide (FeNO) levels at 24 months	Recorded in ppb using the mean of two reproducible measurements. (Month 24 value - baseline value)	Baseline and month 24
Change from baseline in percentage of sputum eosinophils at 24 months	Determined from induced sputum analysis. (Month 24 sputum eosinophil percentages - baseline sputum eosinophil percentages)	Baseline and month 24
Change from baseline in percentage of sputum neutrophils	Determined from induced sputum analysis. (Month 24 sputum neutrophil percentages - baseline sputum neutrophil percentages).	Baseline and month 24

Collaborators and Investigators

• Sponsor: Laval University
• Collaborators: GlaxoSmithKline
• Investigators: Principal Investigator: Andréanne Côté, MD, IUCPQ-UL

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2021
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: September 28, 2020
• First Submitted That Met QC Criteria: October 2, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 7, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: exacerbation; monoclonal antibody; inflammation
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: CÉR21903

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No