Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2000 participants
OBSERVATIONAL
2019-09-10
2025-09-30
Brief Summary
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Other European or international cohorts of asthmatic patients exist and RAMSES could contribute to data sharing initiatives.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
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 not benefiting from health insurance coverage
* Patient under curatorship or tutorship
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Camille TAILLE, MD,PHD
Role: STUDY_CHAIR
Assistance Publique - Hôpitaux de Paris
Locations
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CHU Bichat
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2018-A03282-53
Identifier Type: REGISTRY
Identifier Source: secondary_id
NI18033J
Identifier Type: -
Identifier Source: org_study_id
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