Status:
RECRUITING
Phenotypic and Functional Characterization of Neutrophils and Eosinophils in Severe Asthma Treated With Biotherapy
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Asthma
Eligibility:
All Genders
18-85 years
Brief Summary
Neutrophils and eosinophils can have different functions. Depending on their environment, they can be more or less active, with more or less inflammatory activity. Biotherapies can reduce the number ...
Detailed Description
Between 3 and 10% of adult asthmatics have a severe form of the disease. The pathophysiology of asthma is dominated by chronic bronchial inflammation of type "T2"" with eosinophil infiltration whose r...
Eligibility Criteria
Inclusion
- 18 years ≤ Age \< 85 years
- Severe asthma as defined by ERS/ATS (European Respiratory Society/American Thoracic Society) 2014: asthma requiring high doses of ICS (inhaled corticosteroid) combined with another control therapy (such as long-acting bronchodilators), whether or not patients are controlled
- Longitudinal group:
- Uncontrolled asthma: ACT score \< 20 and/or at least one exacerbation in the last 6 months
- Naïve about biotherapy
- Indication for the initiation of biotherapy according to the referring pulmonologist (omalizumab, mepolizumab, benralizumab, dupilumab)
- Cross-sectional group:
- Patient on biotherapy (omalizumab, mepolizumab, benralizumab, dupilumab) for at least 6 months.
- Controlled asthma (ACT \> 20 and no exacerbation for 6 months) or uncontrolled asthma (ACT \< 20 and/or at least 1 exacerbation for 6 months).
Exclusion
- Refusal to participate or opposition to data processing
- Patient under guardianship or with curators
- Patient on immunosuppressant (other than corticosteroids)
- Treatment with biotherapy for another indication
- Patient not affiliated to a social security scheme or state medical aid
Key Trial Info
Start Date :
July 21 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 21 2024
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT05972213
Start Date
July 21 2023
End Date
May 21 2024
Last Update
January 5 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hôpital Bichat-Claude Bernard
Paris, France, 75018