NCT04763447RecruitingPhase 4
Short Treatment with Omalizumab for Severe Asthma
Impact of Omalizumab Withdrawal After a 3 Year Duration Treatment in Well Controlled Severe Allergic Asthma : a Multicentric Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 7 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 234 (estimated)
- First submitted
- 17 Feb 2021
- Start date
- 20 May 2021
- Primary completion date
- 20 May 2027
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Asthma
- NCT number
- NCT04763447
- EU CT number
- 2024-513427-17-00
- EudraCT number
- 2020-000883-42
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 234
- From 20 May 2021 to the primary completion date, 20 May 2027
- 43 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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, …)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (43)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire Amiens Picardie Coordinator of this site? Confirm its status | Amiens Cedex 1 | France | Recruiting |
| Centre Hospitalier Universitaire D'Angers Coordinator of this site? Confirm its status | Angers | France | Recruiting |
| Centre Hospitalier Victor Dupouy Coordinator of this site? Confirm its status | Argenteuil Cedex | France | Recruiting |
| Centre Hospitalier de la Cote Basque Coordinator of this site? Confirm its status | Bayonne | France | Recruiting |
| Besancon University Hospital Center Coordinator of this site? Confirm its status | Besancon Cedex | France | Recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Bobigny | France | Recruiting |
| Direction Centrale Du Service De Sante Des Armees Coordinator of this site? Confirm its status | Brest | France | Recruiting |
| Centre Hospitalier Régional et Universitaire de Brest Coordinator of this site? Confirm its status | Brest | France | Recruiting |
| Centre Hospitalier Universitaire De Caen Normandie Coordinator of this site? Confirm its status | Caen Cedex 9 | France | Recruiting |
| University Hospital Of Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont Ferrand Cedex 1 | France | Recruiting |
| Centre Hospitalier Intercommunal Créteil Coordinator of this site? Confirm its status | Créteil | France | Recruiting |
| Centre Hospitalier Universitaire de Dijon Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| Centre Hospitalier Eure-Seine Coordinator of this site? Confirm its status | Evreux | France | Recruiting |
| Centre Hospitalier Universitaire Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble Cedex 9 | France | Recruiting |
| Les Hopitaux De Chartres Coordinator of this site? Confirm its status | Le Coudray | France | Recruiting |
| Groupe Hospitalier Du Havre Coordinator of this site? Confirm its status | Le Havre Cedex | France | Recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Le Kremlin-Bicetre | France | Recruiting |
| Centre Hospitalier Le Mans Coordinator of this site? Confirm its status | Le Mans Cedex 9 | France | Recruiting |
| Centre Hospitalier Universitaire de Lille Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| Hôpital Privé La Louviere Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| Hospices Civils De Lyon Coordinator of this site? Confirm its status | Lyon Cedex 04 | France | Recruiting |
| Olivier Cecile Coordinator of this site? Confirm its status | Marcq En Baroul | France | Recruiting |
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Groupe Hospitalier Intercommunal Le Raincy Montfermeil Coordinator of this site? Confirm its status | Montfermeil | France | Recruiting |
| Valcke Judith Coordinator of this site? Confirm its status | Nogent Sur Marne | France | Recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| GIE Groupe hospitalier Paris Saint-Joseph/Vinci Coordinator of this site? Confirm its status | Paris Cedex 14 | France | Recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 18 | France | Recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Pierre-Bénite | France | Recruiting |
| Centre Hospitalier Intercommunal De Poissy Saint Germain Coordinator of this site? Confirm its status | Poissy | France | Recruiting |
| Hôpital NOVO Coordinator of this site? Confirm its status | Pontoise | France | Recruiting |
| Centre Hospitalier Annecy Genevois Coordinator of this site? Confirm its status | Pringy Cedex | France | Recruiting |
| Centre Hospitalier Universitaire Reims Coordinator of this site? Confirm its status | Reims | France | Recruiting |
| Centre hospitalier de Roubaix Coordinator of this site? Confirm its status | Roubaix | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Saint-Herblain | France | Recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex | France | Recruiting |
| Hospital Foch Coordinator of this site? Confirm its status | Suresnes | France | Recruiting |
| Centre Hospitalier Tarbes-Lourdes Coordinator of this site? Confirm its status | Tarbes Cedex 9 | France | Recruiting |
| Centre Hospitalier Universitaire de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| Centre Hospitalier Régional Universitaire de Tours Coordinator of this site? Confirm its status | Tours | France | Recruiting |
| Hopitaux Prives De Metz Coordinator of this site? Confirm its status | Vantoux | France | Recruiting |
| Centre Hospitalier Eure-Seine Coordinator of this site? Confirm its status | Vernon | France | Recruiting |
| Les Hopitaux Nord-Ouest Coordinator of this site? Confirm its status | Villefranche Sur Saone Cedex | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.