Severe Asthma Exacerbations and Mepolizumab Treatment

NCT04914078 | Unknown

• 1 other identifier: 82/2021/Oss/AOUFe - ESAMBIO
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This is a hypothesis-generating project to investigate a) infective etiology and b) inflammatory profile of the exacerbations of asthma in severe asthmatic patients treated with the humanized monoclonal antibody against interleukin-5 Mepolizumab. Under these treatment conditions the study will inform on the relationship between these two axes: infection \& innate immunity Vs inflammatory profile changes occurring during exacerbation events. In addition, the study will also explore the effect of Mepolizumab treatment on airway microbial composition and on airway/systemic immune response both at stable state and at the exacerbation.

Conditions

Severe Asthma

Keywords

asthma; exacerbations; eosinophils; infections; mepolizumab

Outcome Measures

Primary Outcomes (2)

• Inflammation

  Co-primary measurements will be: i) changes in blood and sputum eosinophil counts at exacerbation compared to stable state

  1 year

• Infections

  Co-primary measurements will be: ii) changes in the frequency of microbial agent detection in sputum samples at exacerbation compared to stable state.

  1 year

Secondary Outcomes (13)

• Lung function FEV1 l

  1 year

• Lung function FEV1 %

  1 year

• Lung function FVC l

  1 year

• Lung function FVC %

  1 year

• Lung function VC l

  1 year

Study Arms (1)

Mepolizumab treated patients

Severe eosinophil severe asthmatic patients treated with anti IL-5 monoclonal antibody Mepolizumab

Drug: Mepolizumab 100 MG

Interventions

Mepolizumab 100 MG DRUG

The patients will treated with subcutaneous Mepolizumab at 100 mg every 30 days. Patients will be recruited among those eligible to Mepolizumab treatment according to the Italian Medicine Agency (AIFA; Agenzia Italiana del Farmaco) guidelines who will accept to participate to the study. In particular inclusion criteria will be: severe (Step 4 and 5 GINA) asthma with at least blood eosinophilic count above 300 cells/mcl at least once in the previous year and ≥150 cells/mcl in the absence of systemic corticosteroid treatment before biological treatment initiation. In addition, one of the following conditions will be required: 1) ≥2 exacerbations in the previous year despite appropriate inhaled treatments or 2) the need for systemic corticosteroids on top of inhaled treatment for at least 6 months in the previous year.

Mepolizumab treated patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Severe eosinophils asthmatic patients

You may qualify if:

• severe asthmatic patients according to GINA document (Step 4 and 5 GINA)
• blood eosinophilic count above 300 cells/mcl at least once in the previous year and ≥150 cells/mcl in the absence of systemic corticosteroid treatment before biological treatment initiation.
• In addition, one of the following conditions will be required: 1) ≥2 exacerbations in the previous year despite appropriate inhaled treatments or 2) the need for systemic corticosteroids on top of inhaled treatment for at least 6 months in the previous year.

You may not qualify if:

• COPD
• Active smoking
• Chronic interstitial lung diseases
• Systemic corticosteroid/immunosuppressive treatments for concomitant conditions other than asthma

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Azienda Ospedaliero Universitaria Ferrara

Ferrara, 44124, Italy

RECRUITING

MeSH Terms

Conditions

Asthma; Infections

Interventions

mepolizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Marco Contoli, MD

CONTACT

+390532688148; ctm@unife.it

Nicholas Battistini

CONTACT

cemicef@unife.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: June 4, 2021
• Study Start: September 21, 2021
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)