Environmental Mycobiota: In-depth Characterisation and Determinants Involved in Asthma Emission
MyCADO
1 other identifier
observational
80
1 country
2
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 and/or the frequency of exacerbations, could make it possible to identify individual and environmental components influencing the evolution of the asthmatic pathology and/or 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2023
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 17, 2023
CompletedFirst Submitted
Initial submission to the registry
March 16, 2023
CompletedFirst Posted
Study publicly available on registry
March 29, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 17, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 17, 2025
CompletedJuly 14, 2023
July 1, 2023
2.2 years
March 16, 2023
July 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
identify differences in bacterial and fungal of the microbial exposome
demonstration of an association between the components of the microbial exposome over an entire year and the response profile to biotherapies used in severe asthma (super-responder vs partial responders), evaluated according to Upham's criteria.
Month 3
identify differences in bacterial and fungal of the microbial exposome
demonstration of an association between the components of the microbial exposome over an entire year and the response profile to biotherapies used in severe asthma (super-responder vs partial responders), evaluated according to Upham's criteria.
Month 6
identify differences in bacterial and fungal of the microbial exposome
demonstration of an association between the components of the microbial exposome over an entire year and the response profile to biotherapies used in severe asthma (super-responder vs partial responders), evaluated according to Upham's criteria.
Month 9
identify differences in bacterial and fungal of the microbial exposome
demonstration of an association between the components of the microbial exposome over an entire year and the response profile to biotherapies used in severe asthma (super-responder vs partial responders), evaluated according to Upham's criteria.
Month 12
Study Arms (1)
Patient who received antibiotic prophylaxis
Severe "T2-High" asthmatics treated with biotherapy
Interventions
The assessment of the microbial exposome will be carried out by the deployment of 4 dust collectors (1 per season) at the patient's home. The evaluation of the endogenous myco-microbiome will be carried out by analyzing patient sputum obtained during follow-up visits or during routine care in the event of an exacerbation.
Eligibility Criteria
The inclusion of patients will be done prospectively among patients \> 18 years old, severe "T2-High" asthmatics treated with biotherapy for more than a year and regularly monitored at the University Hospitals of Bordeaux and Toulouse.The monitoring of the asthmatic pathology must also have been well carried out the year preceding inclusion in MyCADO, with in particular the evaluation of the initial response to biotherapy and the number of exacerbations that occurred during this year.
You may qualify if:
- Patients \> 18 years old,
- Patient with severe "T2-High" asthmatics,
- Treated with biotherapy for more than a year
- Regularly monitored at the University Hospitals of Bordeaux and Toulouse.
You may not qualify if:
- Severe asthmatic patients who have been treated with biotherapy for less than a year
- Severe asthmatic patients who have not been treated,
- Not Severe asthmatic patients
- Patient who are not regularly monitored at the Bordeaux and/or Toulouse University Hospitals
- Patients under the protection of justice, under guardianship, under curatorship.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Bordeauxlead
- University of Bordeauxcollaborator
Study Sites (2)
University Hospital, Bordeaux
Bourdeaux, 33000, France
University Hospital, Toulouse
Toulouse, 31000, France
Biospecimen
lung exacerbations
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sébastien IMBERT
University Hospital, Bordeaux
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2023
First Posted
March 29, 2023
Study Start
January 17, 2023
Primary Completion
April 17, 2025
Study Completion
April 17, 2025
Last Updated
July 14, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share