Ignite Creation Date:
2024-05-06 @ 6:47 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05789927
Status:
RECRUITING
Last Update Posted:
2023-07-14
First Post:
2023-03-16
Brief Title:
Environmental Mycobiota In-depth Characterisation and Determinants Involved in Asthma Emission
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Environmental Mycobiota In-depth Characterisation and Determinants Involved in Asthma Emission
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
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:
MyCADO
Brief Summary:
The analysis of the exposome of severe asthmatic patients and its correlation with the response profile to biotherapies used in the treatment of severe asthma andor the frequency of exacerbations could make it possible to identify individual and environmental components influencing the evolution of the asthmatic pathology andor response to treatment An interventional approach could thus be developed taking into account in particular the determinants of indoor air quality as well as the obstacles to the implementation of current recommendations for the prevention of exacerbations
The patient will thus be returned to the center and considered as a main actor in his clinical history by offering him the most suitable intervention possible according to the evaluation of his exposome in order to ultimately reduce the morbidity and mortality linked to exacerbations
This interventional approach could then be validated on a larger scale in a national multicenter study involving a larger number of patients
The patient will thus be returned to the center and considered as a main actor in his clinical history by offering him the most suitable intervention possible according to the evaluation of his exposome in order to ultimately reduce the morbidity and mortality linked to exacerbations
This interventional approach could then be validated on a larger scale in a national multicenter study involving a larger number of patients
Detailed Description:
Nowadays 5 to 10 of the population of developed countries suffer from asthma whose morbidity and mortality represent approximately 1 in years of life lost Within this asthmatic population there is a subgroup of patients with severe asthma 10 of total asthmatics These severe asthma patients have a high risk of complications and exacerbations poor quality of life and increased mortality and morbidity Moreover these severe asthmatics represent 50 of the total health care costs associated with asthma Among the formidable complications of severe asthma exacerbations are still responsible for 900 deaths per year in France while most of them are considered avoidable
Severe asthma is currently described as a heterogeneous disease composed of multiple phenotypes themselves linked to different pathophysiological mechanisms that define theendotypes Phenotypic and endotypic characterization is important for the management of severe asthma as recent therapeutic developments now make it possible to specifically target certain endotypesIn effectin recent years the development of new treatments using monoclonal antibodies biotherapies has improved the management of severe asthmatic patients with the T2-High phenotype with a reduction in the frequency of exacerbations However the response to these new biotherapies is heterogeneous with super-responder patients absence of exacerbations partial responder patients decrease but persistence of exacerbations and non-responder patients no effect on exacerbations
Severe asthma the diversity of phenotypesendotypes observed the frequency of exacerbations and the response to treatment result from a combination of genetic and environmental factors The exposome which designates all of the exposures to external and environmental factors that a human undergoes from his development in utero until death could therefore play a key role in the evolution of severe asthmatic pathology Among these components of the exposome the team find in particular microbial exposure or environmental micro-mycobiota including the omnipresent fungal spores in the air everybody breathe Thus in line with the hygienist hypothesis recent studies have shown that environmental microbial exposures during early childhood significantly reduced the incidence of respiratory disease in children with genetic susceptibility at chromosome 17q21 Additionally chronic exposure to a microbial environment particularly the fungal indoor environment is associated with a wide range of adverse health effects including asthma and may influence its severity More recently severe asthma has also been associated with pulmonary microbial dysbiosis that would activate the inflammasome and other mediated pathways However the exposome is one of the factors that can influence this pulmonary microbial dysbiosis particularly the fungal indoor environment is associated with a wide range of adverse health effects including asthma and may influence its severity More recently severe asthma has also been associated with pulmonary microbial dysbiosis that would activate the inflammasome and other mediated pathways However the exposome is one of the factors that can influence this pulmonary microbial dysbiosis particularly the fungal indoor environment is associated with a wide range of adverse health effects including asthma and may influence its severity More recently severe asthma has also been associated with pulmonary microbial dysbiosis that would activate the inflammasome and other mediated pathways However the exposome is one of the factors that can influence this pulmonary microbial dysbiosis
Severe asthma is currently described as a heterogeneous disease composed of multiple phenotypes themselves linked to different pathophysiological mechanisms that define theendotypes Phenotypic and endotypic characterization is important for the management of severe asthma as recent therapeutic developments now make it possible to specifically target certain endotypesIn effectin recent years the development of new treatments using monoclonal antibodies biotherapies has improved the management of severe asthmatic patients with the T2-High phenotype with a reduction in the frequency of exacerbations However the response to these new biotherapies is heterogeneous with super-responder patients absence of exacerbations partial responder patients decrease but persistence of exacerbations and non-responder patients no effect on exacerbations
Severe asthma the diversity of phenotypesendotypes observed the frequency of exacerbations and the response to treatment result from a combination of genetic and environmental factors The exposome which designates all of the exposures to external and environmental factors that a human undergoes from his development in utero until death could therefore play a key role in the evolution of severe asthmatic pathology Among these components of the exposome the team find in particular microbial exposure or environmental micro-mycobiota including the omnipresent fungal spores in the air everybody breathe Thus in line with the hygienist hypothesis recent studies have shown that environmental microbial exposures during early childhood significantly reduced the incidence of respiratory disease in children with genetic susceptibility at chromosome 17q21 Additionally chronic exposure to a microbial environment particularly the fungal indoor environment is associated with a wide range of adverse health effects including asthma and may influence its severity More recently severe asthma has also been associated with pulmonary microbial dysbiosis that would activate the inflammasome and other mediated pathways However the exposome is one of the factors that can influence this pulmonary microbial dysbiosis particularly the fungal indoor environment is associated with a wide range of adverse health effects including asthma and may influence its severity More recently severe asthma has also been associated with pulmonary microbial dysbiosis that would activate the inflammasome and other mediated pathways However the exposome is one of the factors that can influence this pulmonary microbial dysbiosis particularly the fungal indoor environment is associated with a wide range of adverse health effects including asthma and may influence its severity More recently severe asthma has also been associated with pulmonary microbial dysbiosis that would activate the inflammasome and other mediated pathways However the exposome is one of the factors that can influence this pulmonary microbial dysbiosis
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