National cohort for patients with severe asthma in France
Research on Severe Asthma
This study is trying to gather information from adults in France with severe asthma to better understand their treatment and improve care for them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, immunotherapy |
| Locations | 1 site (Paris) |
| Trial ID | NCT04077528 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish a national cohort of adult patients suffering from severe asthma in France, focusing on those receiving step 4 and 5 treatments. The study will involve a thorough evaluation of patients over 6 to 12 months to accurately diagnose severe asthma and differentiate it from difficult asthma. By collecting and analyzing data on treatment outcomes and management strategies, the study seeks to enhance understanding of this patient population and contribute to data sharing initiatives across Europe. The findings may also support post-registration studies required by health authorities for new therapies.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with severe asthma who are receiving high doses of inhaled corticosteroids and additional treatments.
Not a fit: Patients who do not meet the criteria for severe asthma or those who are not willing to have their data recorded will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies and treatment options for patients with severe asthma.
How similar studies have performed: Other cohorts of asthmatic patients have shown success in data collection and management strategies, indicating that this approach is supported by previous research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: - Patient with severe asthma : Meeting the definition of ATS-ERS: which requires a combination of high dose CSI and B2LDA. Or receiving level 5 support (initiating treatment or already treated) : * Long-term oral corticosteroids (\> 6 months in the year prior to inclusion) * And / or monoclonal antibody * And / or bronchial thermoplasty * And / or other complex costs corresponding to the level 5 treatments * Consultant or hospitalized in one of the centers participating in RAMSES study Exclusion Criteria: * Patient does not accept the recording of his data in the cohort * Patient not benefiting from health insurance coverage * Patient under curatorship or tutorship
Where this trial is running
Paris
- CHU Bichat — Paris, France (Recruiting)
Study contacts
- Study coordinator: Camille TAILLE, 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.