Severe Asthma Clinical Trial
— ESAM-BIOOfficial title:
Exacerbations of Severe Asthma in Patients Treated With Mepolizumab: Assessment of Biomarkers and Identification of Biologic Clusters
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.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | December 1, 2023 |
Est. primary completion date | September 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliero Universitaria Ferrara | Ferrara |
Lead Sponsor | Collaborator |
---|---|
Università degli Studi di Ferrara | GlaxoSmithKline |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Inflammation | Co-primary measurements will be: i) changes in blood and sputum eosinophil counts at exacerbation compared to stable state | 1 year | |
Primary | 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 | Lung function FEV1 l | FEV1 litre | 1 year | |
Secondary | Lung function FEV1 % | FEV1% predicted | 1 year | |
Secondary | Lung function FVC l | FVC litre | 1 year | |
Secondary | Lung function FVC % | FVC % predicted | 1 year | |
Secondary | Lung function VC l | vital capacity (VC) litre | 1 year | |
Secondary | Lung function VC % | vital capacity (VC) % predicted | 1 year | |
Secondary | Lung function - Impulsed Oscillometry kPa | R5-R20 (kPa/L/s) | 1 year | |
Secondary | Lung function - Impulsed Oscillometry % | R5-R20 % predicted | 1 year | |
Secondary | Asthma control questionnaire (ACT) | Score ranging from 5 to 25 | 1 year | |
Secondary | Fractional exhaled nitric oxide (FeNO) | parts per billions (ppb) in the exhaled breath | 1 year | |
Secondary | Sputum Quantitative bacteriology | Serial dilutions (up to 10-12) of sputum samples will be made and cultured on the appropriate media. Colony- forming units (CFU)/mL will be calculated. | 1 year | |
Secondary | Sputum virus profiling | The commercially available multiplex PCR assay RespiFinder RGĀ® (Qiagen) was used according to manufacture instructions for the simultaneous detection and differentiation of 21 respiratory pathogens, including both viruses and atypical bacteria | 1 year | |
Secondary | Cytokines | cytokines profiling (Th1/Th2/Th17 - pg/ml) in blood serum and sputum supernatants will be assessed by by multiplex immunoassay-based (EMD Millipore Burlington, MA, USA) | 1 year |
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