Residual Exacerbations With Mepolizumab

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04578171
• Other study ID #: CÉR21903
• Status: Not yet recruiting
• Start date: March 2021
• Est. completion date: January 2023

Study information

• Verified date: February 2021
• Source: Laval University
• Contact: Marie-Eve Boulay, MSc
• Phone: 4186568711
• Email: marie-eve.boulay[@]criucpq.ulaval.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Mepolizumab
100 mg subcutaneous injections every four weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Laval University	GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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