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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

Full criteria on ClinicalTrials.gov

Sites (43)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier Universitaire Amiens Picardie
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Amiens Cedex 1FranceRecruiting
Centre Hospitalier Universitaire D'Angers
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AngersFranceRecruiting
Centre Hospitalier Victor Dupouy
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Argenteuil CedexFranceRecruiting
Centre Hospitalier de la Cote Basque
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BayonneFranceRecruiting
Besancon University Hospital Center
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Besancon CedexFranceRecruiting
Assistance Publique Hopitaux De Paris
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BobignyFranceRecruiting
Direction Centrale Du Service De Sante Des Armees
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BrestFranceRecruiting
Centre Hospitalier Régional et Universitaire de Brest
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BrestFranceRecruiting
Centre Hospitalier Universitaire De Caen Normandie
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Caen Cedex 9FranceRecruiting
University Hospital Of Clermont-Ferrand
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Clermont Ferrand Cedex 1FranceRecruiting
Centre Hospitalier Intercommunal Créteil
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CréteilFranceRecruiting
Centre Hospitalier Universitaire de Dijon
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DijonFranceRecruiting
Centre Hospitalier Eure-Seine
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EvreuxFranceRecruiting
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceRecruiting
Les Hopitaux De Chartres
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Le CoudrayFranceRecruiting
Groupe Hospitalier Du Havre
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Le Havre CedexFranceRecruiting
Assistance Publique Hopitaux De Paris
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Le Kremlin-BicetreFranceRecruiting
Centre Hospitalier Le Mans
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Le Mans Cedex 9FranceRecruiting
Centre Hospitalier Universitaire de Lille
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LilleFranceRecruiting
Hôpital Privé La Louviere
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LilleFranceRecruiting
Hospices Civils De Lyon
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Lyon Cedex 04FranceRecruiting
Olivier Cecile
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Marcq En BaroulFranceRecruiting
Centre Hospitalier Regional De Marseille
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MarseilleFranceRecruiting
Groupe Hospitalier Intercommunal Le Raincy Montfermeil
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MontfermeilFranceRecruiting
Valcke Judith
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Nogent Sur MarneFranceRecruiting
Assistance Publique Hopitaux de Paris
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ParisFranceRecruiting
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
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Paris Cedex 14FranceRecruiting
Assistance Publique Hopitaux De Paris
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Paris Cedex 18FranceRecruiting
Hospices Civils de Lyon
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Pierre-BéniteFranceRecruiting
Centre Hospitalier Intercommunal De Poissy Saint Germain
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PoissyFranceRecruiting
Hôpital NOVO
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PontoiseFranceRecruiting
Centre Hospitalier Annecy Genevois
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Pringy CedexFranceRecruiting
Centre Hospitalier Universitaire Reims
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ReimsFranceRecruiting
Centre hospitalier de Roubaix
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RoubaixFranceRecruiting
Centre Hospitalier Universitaire de Nantes
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Saint-HerblainFranceRecruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg CedexFranceRecruiting
Hospital Foch
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SuresnesFranceRecruiting
Centre Hospitalier Tarbes-Lourdes
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Tarbes Cedex 9FranceRecruiting
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceRecruiting
Centre Hospitalier Régional Universitaire de Tours
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ToursFranceRecruiting
Hopitaux Prives De Metz
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VantouxFranceRecruiting
Centre Hospitalier Eure-Seine
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VernonFranceRecruiting
Les Hopitaux Nord-Ouest
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Villefranche Sur Saone CedexFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.