Informations générales (source: ClinicalTrials.gov)
Impact of Omalizumab Withdrawal After a 3 Year Duration Treatment in Well Controlled Severe Allergic Asthma : a Multicentric Randomized Controlled Trial (SHORTEN)
Interventional
Phase 4
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
mai 2021
mai 2027
08 novembre 2024
The optimal duration of the treatment by OMA remains unclear when asthma is well
controlled. Data suggest that a large part of patients with well controlled asthma can
discontinue OMA therapy without any asthma control deterioration or with an acceptable
decrease in asthma control, therefore French experts propose that omalizumab can be given
for "3 to 5 yrs if asthma remains well controlled".
The costs related to OMA are high and frequent injections represent severe constraints
for patients. For all these reasons, evaluating whether shortening duration of OMA
therapy is feasible while maintaining acceptable asthma control is a critical point.
Therefore, the aim of this study is to evaluate asthma control after OMA discontinuation
after at least 33 months of treatment when asthma is well controlled.
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 | 18/04/2025 07:55:15 | Contacter | ||
AP-HP - Hôpital Bicêtre | TAILLE Camille | 18/04/2025 07:55:15 | Contacter | ||
AP-HP - Hôpital Bichat | TAILLE Camille | 18/04/2025 07:55:15 | Contacter | ||
AP-HP - Hôpital Europeen Georges Pompidou | TAILLE Camille | 18/04/2025 07:55:15 | Contacter | ||
AP-HP - Hôpital La Pitié-Salpêtrière | TAILLE Camille | 18/04/2025 07:55:15 | Contacter | ||
HOPITAL FOCH | COLAS TCHERAKIAN | 05/05/2025 07:12:09 | Contacter | ||
HOPITAL NOVO | BOITIAUX Jean-François | 14/02/2025 09:03:20 | Contacter |
Critères
Tous
Inclusion Criteria:
- Adult patient >18 years old
- Treated with OMA, prescribed by a pulmonologist , for at least 33 months for severe
allergic asthma
- Well controlled with the treatment (ACT score ⩾ 18) and having experienced no more
than one exacerbation in the year preceding inclusion. An exacerbation is defined as
an oral or injectable steroid course for at least 2 days and/or a minimum doubling
of the usual steroid dose for at least 2 days for steroid dependent patients
- Adult patient >18 years old
- Treated with OMA, prescribed by a pulmonologist , for at least 33 months for severe
allergic asthma
- Well controlled with the treatment (ACT score ⩾ 18) and having experienced no more
than one exacerbation in the year preceding inclusion. An exacerbation is defined as
an oral or injectable steroid course for at least 2 days and/or a minimum doubling
of the usual steroid dose for at least 2 days for steroid dependent patients
- Patient refusing to stop OMA treatment, whatever the reason
- Patient with other reason other than good asthma control to stop OMA, such as a side
effect, planned or ongoing pregnancy, or planned switch to another step 5 asthma
treatment (mepolizumab, benralizumab, dupilumab, reslizumab, daily oral steroids,
bronchial thermoplasty, ...)
- Patient not covered by Health Insurance
- Patient under curatorship, guardianship or safeguarding of justice
- Patient whose adherence to asthma treatments is considered poor or questionable by
the investigator
- Patient participating in another intervention research
- Pregnant or lactating patient
- Patient refusing to sign consent