Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT04077528 En recrutement IDF

Titre

Research on Severe Asthma (RAMSES)

Type

Observational

Pathologie

Asthme

Phase

Promoteur

Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)

Date de début

septembre 2019

Date de fin

septembre 2025

Dernière mise à jour

29 juin 2024

Résumé

The French Society for Respiratory diseases (SPLF), through its Asthma and Allergy working group (G2A), wishes to set up a national cohort of severe asthma patients to describe this population and the use of step 4 and 5 treatment. This study also meets the demand for post - registration studies required by the Health Authorities for biotherapies and bronchial thermoplasty. Other European or international cohorts of asthmatic patients exist and RAMSES could contribute to data sharing initiatives.

Détail

Voir le détail Severe asthma is defined by poorly controlled disease despite treatment with high doses of inhaled corticosteroids, in combination with at least a long acting beta agonist, after optimal management for at least 6 months by an asthma specialist. The diagnosis of severe asthma can only be made after a rigorous evaluation of 6 to 12 months, including the review of diagnosis and treatment, by a pulmonologist, to distinguish difficult asthma from severe asthma. Severe asthma accounts for 3.5% to 5% of all asthma patients, a population estimated at 150 000 patients in France. This disease is responsible for significant health costs related to asthma treatments, comorbidities, hospitalizations and sick days. The management of severe asthma is complex, multidisciplinary and includes drug treatment, but also the management of side effects of treatment, including oral corticosteroid therapy, and comorbidities of asthma. Until 2018, omalizumab,systemic continuous oral corticosteroid therapy or inclusion in a therapeutic trial were the ony possibilities offered to severe asthmatic patients beyond the usually recommended and optimized management. In 2018, mepolizumab and reslizumab have been marketed in France, then benralizumab in 2019. They will probably be followed by dupilumab and bronchial thermoplasty. New initiatives to change the history of the disease are also proposed such as specific immunotherapy or long-term use of macrolides. Respiratory rehabilitation is also part of the treatments to be evaluated in some groups of patients. The description of the use of these treatments, as well as the evaluation of their effectiveness and tolerance in real life conditions is essential. Indeed, their use outside clinical trials raises a number of issues such as the optimal duration of treatment, the maintenance of efficacy over extended periods, the risk and the time to relapse when the treatment is stopped, the possibility to switch from one biotherapy to another in case of insufficient clinical response or to associate them which may prove to be an effective strategy in patients eligible for two biotherapies (allergic and eosinophilic patients). The cost of these treatments is high. The pharmaco-economic evaluation of severe asthma and its management is another important element. For example, no economic evaluation of the use of omalizumab is currently available in France. Lastly, the organization of a care network dedicated to severe asthma is being launched in France (severe asthma centers ), on the model of European countries, in order to improve the diagnosis and management of these patients and to reduce the burden of comorbidities of asthma and steroids side effects.It is therefore essential to set up a clinical research structure that will make it possible to obtain clinical data on this population of severe asthma patients and to evaluate all medical practices in real life conditions. Fermer le détail

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
AP-HP - Hôpital Avicenne	TAILLE Camille	Active, sans recrutement	12/04/2024 09:28:35	Contacter
AP-HP - Hôpital Bicêtre	TAILLE Camille	Active, sans recrutement	12/04/2024 09:28:35	Contacter
AP-HP - Hôpital Bichat	TAILLE Camille	Active, sans recrutement	12/04/2024 09:28:35	Contacter
AP-HP - Hôpital Cochin	TAILLE Camille	Active, sans recrutement	12/04/2024 09:28:35	Contacter
AP-HP - Hôpital Europeen Georges Pompidou	TAILLE Camille	Active, sans recrutement	12/04/2024 09:28:35	Contacter
AP-HP - Hôpital La Pitié-Salpêtrière	TAILLE Camille	Active, sans recrutement	12/04/2024 09:28:35	Contacter
CHI DE CRETEIL	Gilles MANGIAPAN	En recrutement IDF	29/03/2024 01:28:39	Contacter
HOPITAL FOCH	COLAS TCHERAKIAN	Active, sans recrutement	21/10/2024 07:07:13	Contacter

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

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

Critère de non inclusion

- Patient does not accept the recording of his data in the cohort

- Patient not benefiting from health insurance coverage

- Patient under curatorship or tutorship

Informations générales (source: ClinicalTrials.gov)

Etablissements

Critères

NCT04077528 - Research on Severe Asthma (RAMSES)