Status:
UNKNOWN
Severe Asthma Exacerbations and Mepolizumab Treatment
Lead Sponsor:
Università degli Studi di Ferrara
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Severe Asthma
Eligibility:
All Genders
18+ years
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 monoclon...
Detailed Description
Longitudinal, observational study to evaluate the infective etiology and the inflammatory profile of asthma exacerbations in severe asthmatic patients treated (as part of routine medical care) with th...
Eligibility Criteria
Inclusion
- The cohort of patients included in the study will consist of severe asthmatic patients receiving Mepolizumab as part of routine medical care, i.e. eligible for Mepolizumab treatment according to the Italian Medicine Agency (AIFA; Agenzia Italiana del Farmaco). The patients will receive Mepolizumab treatment irrespective of the enrollment in the study but because of the clinical indication.
- Inclusion criteria:
- 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.
- Exclusion criteria:
- COPD
- Active smoking
- Chronic interstitial lung diseases
- Systemic corticosteroid/immunosuppressive treatments for concomitant conditions other than asthma
Exclusion
Key Trial Info
Start Date :
September 21 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04914078
Start Date
September 21 2021
End Date
December 1 2023
Last Update
May 18 2022
Active Locations (1)
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1
Azienda Ospedaliero Universitaria Ferrara
Ferrara, Italy, 44124