Tests stopping omalizumab injections in well-controlled severe allergic asthma
Tests stopping omalizumab in adults with well-controlled severe allergic asthma.
Plain-language title generated from the registry record
Registry title: Short Treatment with Omalizumab for Severe Asthma
Key facts
- Where
- Amiens Cedex 1, Angers, Argenteuil Cedex, Bayonne, Besancon Cedex, Bobigny, Brest, Caen Cedex 9, Clermont Ferrand Cedex 1, Créteil, Dijon, Evreux, Grenoble Cedex 9, Le Coudray, Le Havre Cedex, Le Kremlin-Bicetre, Le Mans Cedex 9, Lille, Lyon Cedex 04, Marcq En Baroul, Marseille, Montfermeil, Nogent Sur Marne, Paris, Paris Cedex 14, Paris Cedex 18, Pierre-Bénite, Poissy, Pontoise, Pringy Cedex, Reims, Roubaix, Saint-Herblain, Strasbourg Cedex, Suresnes, Tarbes Cedex 9, Toulouse, Tours, Vantoux, Vernon, and Villefranche Sur Saone Cedex, FranceSee the 43 sites
- Phase
- Phase 4
Where in France
- Centre Hospitalier Universitaire Amiens PicardieAmiens Cedex 1, FranceTaking people
- Centre Hospitalier Universitaire D'AngersAngers, FranceTaking people
- Centre Hospitalier Victor DupouyArgenteuil Cedex, FranceTaking people
- Centre Hospitalier de la Cote BasqueBayonne, FranceTaking people
- Besancon University Hospital CenterBesancon Cedex, FranceTaking people
- Assistance Publique Hopitaux De ParisBobigny, FranceTaking people
- Centre Hospitalier Régional et Universitaire de BrestBrest, FranceTaking people
- Direction Centrale Du Service De Sante Des ArmeesBrest, FranceTaking people
- Centre Hospitalier Universitaire De Caen NormandieCaen Cedex 9, FranceTaking people
- University Hospital Of Clermont-FerrandClermont Ferrand Cedex 1, FranceTaking people
- Centre Hospitalier Intercommunal CréteilCréteil, FranceTaking people
- Centre Hospitalier Universitaire de DijonDijon, FranceTaking people
- Centre Hospitalier Eure-SeineEvreux, FranceTaking people
- Centre Hospitalier Universitaire Grenoble AlpesGrenoble Cedex 9, FranceTaking people
- Les Hopitaux De ChartresLe Coudray, FranceTaking people
- Groupe Hospitalier Du HavreLe Havre Cedex, FranceTaking people
- Assistance Publique Hopitaux De ParisLe Kremlin-Bicetre, FranceTaking people
- Centre Hospitalier Le MansLe Mans Cedex 9, FranceTaking people
- Centre Hospitalier Universitaire de LilleLille, FranceTaking people
- Hôpital Privé La LouviereLille, FranceTaking people
- Hospices Civils De LyonLyon Cedex 04, FranceTaking people
- Olivier CecileMarcq En Baroul, FranceTaking people
- Centre Hospitalier Regional De MarseilleMarseille, FranceTaking people
- Groupe Hospitalier Intercommunal Le Raincy MontfermeilMontfermeil, FranceTaking people
- Valcke JudithNogent Sur Marne, FranceTaking people
- Assistance Publique Hopitaux de ParisParis, FranceTaking people
- GIE Groupe hospitalier Paris Saint-Joseph/VinciParis Cedex 14, FranceTaking people
- Assistance Publique Hopitaux De ParisParis Cedex 18, FranceTaking people
- Hospices Civils de LyonPierre-Bénite, FranceTaking people
- Centre Hospitalier Intercommunal De Poissy Saint GermainPoissy, FranceTaking people
- Hôpital NOVOPontoise, FranceTaking people
- Centre Hospitalier Annecy GenevoisPringy Cedex, FranceTaking people
- Centre Hospitalier Universitaire ReimsReims, FranceTaking people
- Centre hospitalier de RoubaixRoubaix, FranceTaking people
- Centre Hospitalier Universitaire de NantesSaint-Herblain, FranceTaking people
- Les Hopitaux Universitaires De StrasbourgStrasbourg Cedex, FranceTaking people
- Hospital FochSuresnes, FranceTaking people
- Centre Hospitalier Tarbes-LourdesTarbes Cedex 9, FranceTaking people
- Centre Hospitalier Universitaire de ToulouseToulouse, FranceTaking people
- Centre Hospitalier Régional Universitaire de ToursTours, FranceTaking people
- Hopitaux Prives De MetzVantoux, FranceTaking people
- Centre Hospitalier Eure-SeineVernon, FranceTaking people
- Les Hopitaux Nord-OuestVillefranche Sur Saone Cedex, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Trial code
- NCT04763447EU 2024-513427-17-00
- Record updated
- 7 November 2024
- Original description
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".Read full original descriptionShow less
Impact of Omalizumab Withdrawal After a 3 Year Duration Treatment in Well Controlled Severe Allergic Asthma : a Multicentric Randomized Controlled Trial
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.
Inclusion: 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.
Exclusion: 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 refusing to stop OMA treatment, whatever the reason; 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.