Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04763447 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Short Treatment with Omalizumab for Severe Asthma

Study acronym: SHORTEN
StatusRecruiting
PhasePhase 4
Started2021-05-20
View on ClinicalTrials.gov ↗

Amendment history

2024-11-06
Study Identification, Study Status, Oversight, Study Description, Outcome Measures, Eligibility, Contacts/Locations v6
Primary completion date2025-05-20→2027-05-20
Completion date2025-05-20→2027-05-20
Eligibility criteria+3 characters
Inclusion Criteria: Adult patient >18 years old Treated with OMA, prescribed by a pulmonologist , for at least 33 to 63 months for severe allergic asthma Well controlled with the [...]
Secondary endpointsdetails revised at 3 of 37 entries
Study description+9 characters
[...] OMA continuation in asthma-controlled patients treated for 3at toleast 533 yearsmonths with OMA. Secondary objectives are to compare OMA withdrawa [...] OMA continuation in asthma-controlled patients treated for at least 33 to 63 months with OMA on other asthma control features at 6 and 12 months.
Study sitescontacts updated at 1 of 1 site
Study titlerevised
Short Treatment Withwith Omalizumab for Severe Asthma
2024-01-17
Study Status v5
Re-verified, no change to tracked fields
2023-06-12
Study Status, Study Description, Outcome Measures, Eligibility, Contacts/Locations v4
Eligibility criteriarevised
Inclusion Criteria: Adult patient >18 years old Treated with OMA, prescribed by a pulmonologist , for 3633 to 6063 months for severe allergic asthma Well controlled with the [...]
Secondary endpoints33 to 37 entries
DosePatients increasing their dose of oral steroids of 20% DosePatients increasing their dose of oral steroids of 20% DosePatients increasing their dose of oral steroids of 50% DosePatients increasing their dose of oral steroids of 50% DosePatients increasing their dose of oral steroids of 80% DosePatients increasing their dose of oral steroids of 80% EffetEffect of OMA treatment duration on asthma control EffetEffect of OMA dosage on asthma control EffetEffect of eosinophils rate on asthma control EffetEffect of OMA treatment duration on time to loss of asthma control EffetEffect of OMA dosag [...] [...]
Study description+3 characters
[...] OMA continuation in asthma-controlled patients treated for 333 to 563 yearsmonths with OMA on other asthma control features at 6 and 12 months.
Study sites1 entry, revised
HöpitalHôpital Bichat-Claude Bernard
2022-10-10
Study Status, Arms and Interventions, Eligibility v3
Eligibility criteria-43 characters
Inclusion Criteria: Patient participating in the RAMSES cohort Adult patient >18 years old Treated with OMA, prescribed by [...]
2022-02-09
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2025-01-01→2025-05-20
Completion date2025-02-01→2025-05-20
Start dateestimated 2021-03-08→confirmed 2021-05-20
Eligibility criteria+1 characters
[...] lergic asthma Well controlled with the treatment (ACT score >⩾ 18) and having experienced no more than one exacerbation in [...]
Study sitesdetails revised at 1 of 1 site
2021-03-02
Study Status, Conditions v1
Re-verified, no change to tracked fields
2021-02-18
Original filing
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.
Trial Details
NCT Number NCT04763447
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Conditions Asthma
Enrollment 234 participants
Start Date 2021-05-20
Primary Completion 2027-05-20 (estimated)
Study Completion 2027-05-20 (estimated)
Updated on ClinicalTrials.gov 2024-11-07