Understanding Neutrophils and Eosinophils in Severe Asthma Treated with Biotherapy
Phenotypic and Functional Characterization of Neutrophils and Eosinophils in Severe Asthma Treated With Biotherapy
This study looks at how a new asthma treatment affects certain immune cells in people with severe asthma to see if it helps improve their symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 105 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | omalizumab, mepolizumab, benralizumab, dupilumab |
| Locations | 1 site (Paris) |
| Trial ID | NCT05972213 on ClinicalTrials.gov |
What this trial studies
This observational study aims to characterize the phenotypic and functional roles of neutrophils and eosinophils in patients with severe asthma undergoing biotherapy. It will investigate how biotherapies, which target specific inflammatory pathways, may alter the behavior of these immune cells and their contribution to asthma symptoms. The study will include both a longitudinal group of patients who are new to biotherapy and a cross-sectional group of patients already receiving treatment. By analyzing these immune cells, the research seeks to uncover insights into the effectiveness of biotherapies in managing severe asthma.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with severe asthma requiring high doses of inhaled corticosteroids and other therapies.
Not a fit: Patients who do not have severe asthma or are not candidates for biotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with severe asthma, enhancing their response to biotherapies.
How similar studies have performed: While there is limited data on the specific roles of neutrophils and eosinophils in asthma under biotherapy, similar studies in other conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Paris
- Hôpital Bichat-Claude Bernard — Paris, France (Recruiting)
Study contacts
- Principal investigator: Camille Taillé, MD, PhD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Camille Taillé, MD, PhD
- Email: camille.taille@aphp.fr
- Phone: 01 40 25 68 63
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.