Residual Exacerbations With Mepolizumab

NCT04578171 | Recruiting

• 1 other identifier: CÉR21903
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

exacerbation; inflammation; monoclonal antibody

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change from baseline in asthma control on the Asthma Control Questionnaire (ACQ-5) at 24 months

  Baseline and month 24

• Change from baseline in post-bronchodilator forced expiratory volume in one second (FEV1) at 24 months

  Baseline and month 24

• Change from baseline in post-bronchodilator FEV1/forced vital capacity (FVC) ratio at 24 months

  Baseline and month 24

• Change from baseline in fraction of exhaled nitric oxide (FeNO) levels at 24 months

  Baseline and month 24

• Change from baseline in percentage of sputum eosinophils at 24 months

  Baseline and month 24

Study Arms (1)

Study population

Subjects with severe asthma treated with mepolizumab

Drug: Mepolizumab

Interventions

Mepolizumab DRUG

100 mg subcutaneous injections every four weeks

Also known as: nucala

Study population

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Laval University: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, G6K 1L8, Canada

RECRUITING

MeSH Terms

Conditions

Asthma; Inflammation

Interventions

mepolizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andréanne Côté, MD

  IUCPQ-UL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Eve Boulay, MSc

CONTACT

4186568711; marie-eve.boulay@criucpq.ulaval.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Respirologist-intensivist

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 8, 2020
• Study Start: July 6, 2021
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)