Ignite Creation Date:
2024-05-06 @ 4:13 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04914078
Status:
UNKNOWN
Last Update Posted:
2022-05-18
First Post:
2021-05-25
Brief Title:
Severe Asthma Exacerbations and Mepolizumab Treatment
Sponsor:
Università degli Studi di Ferrara
Organization:
Università degli Studi di Ferrara
Study Overview
Official Title:
Exacerbations of Severe Asthma in Patients Treated With Mepolizumab Assessment of Biomarkers and Identification of Biologic Clusters
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESAM-BIO
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 airwaysystemic immune response both at stable state and at the exacerbation
In addition the study will also explore the effect of Mepolizumab treatment on airway microbial composition and on airwaysystemic immune response both at stable state and at the exacerbation
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 the humanized monoclonal antibody against interleukin-5 Mepolizumab
The participants receive Mepolizumab as part of routine medical care see inclusion criteria The study will assess the effect of the intervention Mepolizumab on airway microbial compositions and on airwaysystemic inflammation at exacerbation and at stable state
The patients will be evaluated at baseline the day of Mepolizumab initiation before Mepolizumab administration - V0 at 1 month after Mepolizumab initiation treatment visit - V1 at exacerbation exacerbation visit - V2 and at 3 months after the exacerbation event convalescence visit - V3 up to 12-month study period Table 1 To perform the convalescence visit a 3-month extension of the study period will be applied if the exacerbation occurs from month 9 to month 12 from the initiation of Mepolizumab Recurrent exacerbation events will be evaluated separately when a paired-3-month convalescence visit can be performed within the study period
The patients will contact the centerresearchers in case of worsening of the respiratory symptoms to schedule the exacerbation visit The visit will be performed within 7 days from the beginning of the deterioration of the symptoms
At each visit the following procedures will be performed in all the patients 1 Clinicalpharmacological assessment including assessment of asthma control and measurements of central and peripheral fractional exhaled nitric oxide 2 lung function tests including lung volumes evaluation and small airway functional assessment by impulse oscillometry - IOS 3 blood and sputum differential inflammatory cell counts 4 sputum samples for microbiological assays conventional sputum cultures and Multiplex Real Time PCR for virus and bacterial detection 5 blood and sputum samples for cytokine profiling
In a representative subgroup of patients n30 breath condensate blood and sputum samples will be performed for 1 airway microbiome 16S ribosomal RNA Sequencing evaluation 2 blood innate immune responses 3 transcriptomics and proteomics of sputum inflammatory cells 4 breathomics
The study has been submitted for approval to the ethics committee and informed written consent will be obtained from each enrolled subject
The participants receive Mepolizumab as part of routine medical care see inclusion criteria The study will assess the effect of the intervention Mepolizumab on airway microbial compositions and on airwaysystemic inflammation at exacerbation and at stable state
The patients will be evaluated at baseline the day of Mepolizumab initiation before Mepolizumab administration - V0 at 1 month after Mepolizumab initiation treatment visit - V1 at exacerbation exacerbation visit - V2 and at 3 months after the exacerbation event convalescence visit - V3 up to 12-month study period Table 1 To perform the convalescence visit a 3-month extension of the study period will be applied if the exacerbation occurs from month 9 to month 12 from the initiation of Mepolizumab Recurrent exacerbation events will be evaluated separately when a paired-3-month convalescence visit can be performed within the study period
The patients will contact the centerresearchers in case of worsening of the respiratory symptoms to schedule the exacerbation visit The visit will be performed within 7 days from the beginning of the deterioration of the symptoms
At each visit the following procedures will be performed in all the patients 1 Clinicalpharmacological assessment including assessment of asthma control and measurements of central and peripheral fractional exhaled nitric oxide 2 lung function tests including lung volumes evaluation and small airway functional assessment by impulse oscillometry - IOS 3 blood and sputum differential inflammatory cell counts 4 sputum samples for microbiological assays conventional sputum cultures and Multiplex Real Time PCR for virus and bacterial detection 5 blood and sputum samples for cytokine profiling
In a representative subgroup of patients n30 breath condensate blood and sputum samples will be performed for 1 airway microbiome 16S ribosomal RNA Sequencing evaluation 2 blood innate immune responses 3 transcriptomics and proteomics of sputum inflammatory cells 4 breathomics
The study has been submitted for approval to the ethics committee and informed written consent will be obtained from each enrolled subject
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None