AsthmaPhase 4SHORTENNCT04763447
Short Treatment with Omalizumab for Severe Asthma
A Phase 4 study testing Attempt to withdrawal OMA treatment and Continuation of OMA treatment in people with Asthma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Attempt to withdrawal OMA treatment and Continuation of OMA treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteFrance
- Study dates
- 20 May 2021to 20 May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Bichat-Claude Bernard
Paris, Île-de-France Region, 75018
Yannick VACHER, Chef de projet DRCI, 01.44.84.17.30 ext. +33, yannick.vacher@aphp.fr
Eve KLISING, Chef de projet CEPHEPI, 01 42 16 75 83 ext. +33, eve.klising@aphp.fr
About this study
Official title: 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.
Read the detailed description
Omalizumab (OMA) is a monoclonal anti IgE antibody, developed for severe uncontrolled allergic asthma. Efficacy of OMA in this indication is well documented in randomized trials as well as in real life studies, reducing the number of severe exacerbations by about 50% and improving asthma control score .
However, despite commercialized since 2006 in France, the optimal duration of the treatment remains unclear when asthma is well controlled. In particular, there is no guideline to apply the "step down theory" to biologics in well controlled patients.
It seems clear that a treatment given for less than one year is associated with an early relapse of the disease. However, in a randomized controlled study including 176 patients, stopping the treatment after 5 years induced a small, but acceptable loss of control (average decrease of asthma control test (ACT) by 2.88 and 1.16 point, p= 0.18), but some patients had uncontrolled asthma when the treatment was stopped. In a smaller cohort of 49 patients in Spain who voluntarily accepted to discontinue OMA treatment after 6 years of therapy, asthma deterioration (defined by one or more exacerbation and any Asthma Control Test change during the 1st year) was observed in 24% of patients during the first year following discontinuation , with a maximal rate of 2 exacerbations/yr. After 4 years of discontinuation, 60% of patients still take advantage of the 6 yrs of treatment with OMA. A retrospective study in France found that 14/26 patients treated for at least 3 years kept the same level of control after discontinuation. All these 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.
Inducing long term asthma remissions, rather than complete cure, is one potential goal of biologics. OMA is supposed to have disease modifying effects , explaining why there is a hope for a good asthma control being maintained after discontinuation. For this reason, French experts propose that omalizumab can be given for "3 to 5 yrs if asthma remains well controlled" . After an asthma relapse, OMA can be prescribed again theoretically, but no data regarding clinical response after a "second line" of treatment with the same biologic are available. The question of optimal treatment duration is also questioned with other biologics.
The costs related to OMA are high (estimated to 12 k€/year/patient). Frequent injections (1 subcutaneous injection every 4 weeks for the lowest dose to 4 injections every 2 weeks for the highest dose) represent severe constraints for patients, especially for the youngest ones. For all these reasons, evaluating whether shortening duration of OMA therapy is feasible while maintaining acceptable asthma control is a critical point. The main objective is to demonstrate the non-inferiority (i.e. no more exacerbations at 12 months) of OMA withdrawal attempt compared to OMA continuation in asthma-controlled patients treated for at least 33 months with OMA. Secondary objectives are to compare OMA withdrawal attempt versus OMA continuation in asthma-controlled patients treated for at least 33 months with OMA on other asthma control features at 6 and 12 months.
- Conditions
- Asthma
- Being tested
- Attempt to withdrawal OMA treatment, Continuation of OMA treatment
- Keywords
- severe asthma, omalizumab, allergy, biologic
- Medical subject headings
- Asthma, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attempt to withdrawal OMA treatmentOther
Patients will be told to stop abruptly (no progressive decrease of the dose) their Omalizumab treatment and they will not be prescribed new OMA. In case of loss of control, pulmonologist can adapt asthma treatment, as in usual care. In that case, OMA can be prescribed for a second line
Continuation of OMA treatmentDrug
Patients will be prescribed the same dosage of Omalizumab than they received before randomization, according to their weight and total circulating IgE levels.
In case of safety concerns or loss of control, pulmonologist can modify the patient treatment regimen of OMA or other co-medications, as in usual care.
| Study group | Role | What they receive |
|---|---|---|
| OMA withdrawal attempt | Experimental | Patients will be told to stop abruptly (no progressive decrease of the dose) their Omalizumab treatment and they will not be prescribed new OMA Receives: Other: Attempt to withdrawal OMA treatment |
| OMA continuation | Active comparator | Patients will be prescribed the same dosage of Omalizumab than they received before randomization Receives: Drug: Continuation of OMA treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of exacerbations
Number of asthma exacerbations in the year following randomization. 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.
They will be assessed every 6 months from patients log book, written reports of ER visits or hospitalizations, and prescriptions
Measured: 12 months
Secondary outcomes (37)
Time to exacerbation
Number of days between the randomization and the first occurence of an exacerbation. 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.
Measured: 12 months
Asthma control (ACT)
Changes in asthma control test (ACT). ACT is a five questions self-administered standardized questionnaire. The ACT contains 5 questions that are related to the frequency of both asthma symptoms and required rescue medication use during the previous 4 weeks. The scores in the ACT range from 5 (worse control) to 25 (total control). A minimal change in 5 points for the total score is considered clinically significant.
Measured: 6 months
Asthma control (ACT)
Changes in asthma control test (ACT). ACT is a five questions self-administered standardized questionnaire. The ACT contains 5 questions that are related to the frequency of both asthma symptoms and required rescue medication use during the previous 4 weeks. The scores in the ACT range from 5 (worse control) to 25 (total control). A minimal change in 5 points for the total score is considered clinically significant.
Measured: 12 months
5 points-decrease of asthma control (ACT)
Percentage of patients with a 5 points decrease of asthma control test (ACT) compared to baseline. ACT is a five questions self-administered standardized questionnaire. The ACT contains 5 questions that are related to the frequency of both asthma symptoms and required rescue medication use during the previous 4 weeks. The scores in the ACT range from 5 (worse control) to 25 (total control). A minimal change in 5 points for the total score is considered clinically significant.
Measured: 6 months
5 points-decrease of asthma control (ACT)
Percentage of patients with a 5 points decrease of asthma control test (ACT) compared to baseline. ACT is a five questions self-administered standardized questionnaire. The ACT contains 5 questions that are related to the frequency of both asthma symptoms and required rescue medication use during the previous 4 weeks. The scores in the ACT range from 5 (worse control) to 25 (total control). A minimal change in 5 points for the total score is considered clinically significant.
Measured: 12 months
Time to loss of asthma control
Number of days between the randomization and the prescription of OMA (in the withdrawal group) or another step 5 asthma treatment (mepolizumab, benralizumab, daily oral steroids, bronchial thermoplasty); according to the pulmonologist's choice.
Measured: 12 months
Asthma quality of life (AQLQ)
Changes in asthma quality of life (AQLQ). The AQLQ is a 32-item disease-specific questionnaire that has been designed to measure the functional impairments that are most troublesome to adults with asthma. Patients are asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale. The overall AQLQ score is the mean response to all 32 questions. Four independent studies have established that the AQLQ has strong measurement properties and validity.
Measured: 6 months
Asthma quality of life (AQLQ)
Changes in asthma quality of life (AQLQ). The AQLQ is a 32-item disease-specific questionnaire that has been designed to measure the functional impairments that are most troublesome to adults with asthma. Patients are asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale. The overall AQLQ score is the mean response to all 32 questions. Four independent studies have established that the AQLQ has strong measurement properties and validity.
Measured: 12 months
Number of asthma controller drugs
Changes in the number of asthma controller drugs
Measured: 6 months
Number of asthma controller drugs
Changes in the number of asthma controller drugs
Measured: 12 months
Dose of inhaled steroids
Changes in the mean daily dose of inhaled steroids received in the 3 previous months
Measured: 6 months
Dose of inhaled steroids
Changes in the mean daily dose of inhaled steroids received in the 3 previous
Measured: 12 months
Dose of oral steroids
Changes in the mean daily dose of oral steroids (for steroid dependent patients)
Measured: 6 months
Dose of oral steroids
Changes in the mean daily dose of oral steroids (for steroid dependent patients)
Measured: 12 months
Patients increasing their dose of oral steroids of 20%
Percentage of patients with a 20% increasing of the dose compared to baseline (for steroid dependent patients)
Measured: 6 months
Patients increasing their dose of oral steroids of 20%
Percentage of patients with a 20% increasing of the dose compared to baseline (for steroid dependent patients)
Measured: 12 months
Patients increasing their dose of oral steroids of 50%
Percentage of patients with a 50% increasing of the dose compared to baseline (for steroid dependent patients)
Measured: 6 months
Patients increasing their dose of oral steroids of 50%
Percentage of patients with a 50% increasing of the dose compared to baseline (for steroid dependent patients)
Measured: 12 months
Patients increasing their dose of oral steroids of 80%
Percentage of patients with a 80% increasing of the dose compared to baseline (for steroid dependent patients)
Measured: 6 months
Patients increasing their dose of oral steroids of 80%
Percentage of patients with a 80% increasing of the dose compared to baseline (for steroid dependent patients)
Measured: 12 months
Allergy manifestations
Occurrence of food allergy (oral syndrome and anaphylactic reactions), conjunctivitis, rhinitis, atopic dermatitis
Measured: 6 months
Allergy manifestations
Occurrence of food allergy (oral syndrome and anaphylactic reactions), conjunctivitis, rhinitis, atopic dermatitis
Measured: 12 months
FEV1
Changes in FEV1
Measured: 6 months
FEV1
Changes in FEV1
Measured: 12 months
Effect of OMA treatment duration on asthma control
Effet of OMA treatment duration before randomization on ACT score. The following categories will be considered: 33-48 months / 49-63 months / more than 63 months
Measured: 12 months
Effect of OMA dosage on asthma control
Effet of OMA dosage before randomization on ACT score. The following categories will be considered: [150-300 mg/month]; ]300-600 mg/month];]600-900 mg/month] and ]900-1200 mg/month]
Measured: 12 months
Effect of eosinophils rate on asthma control
Effet of OMA eosinophils rate at randomization on ACT score. The following categories will be considered: <300/mm3;≥300/mm3.
Measured: 12 months
Effect of OMA treatment duration on time to loss of asthma control
Effet of OMA treatment duration before randomization on time to loss of asthma control. Time to loss of asthma control is defined as the number of days between the randomization and the prescription of OMA (in the withdrawal group) or another step 5 asthma treatment (mepolizumab, benralizumab, daily oral steroids, bronchial thermoplasty); according to the pulmonologist's choice. The following categories will be considered: 33-48 months / 49-63 months / more than 63 months
Measured: 12 months
Effect of OMA dosage on time to loss of asthma control
Effet of OMA dosage before randomization on time to loss of asthma control. Time to loss of asthma control is defined as the number of days between the randomization and the prescription of OMA (in the withdrawal group) or another step 5 asthma treatment (mepolizumab, benralizumab, daily oral steroids, bronchial thermoplasty); according to the pulmonologist's choice. The following categories will be considered: [150-300 mg/month]; ]300-600 mg/month];]600-900 mg/month] and ]900-1200 mg/month]
Measured: 12 months
Effect of eosinophils rate on time to loss of asthma control
Effet of OMA eosinophils rate at randomization on time to loss of asthma control. Time to loss of asthma control is defined as the number of days between the randomization and the prescription of OMA (in the withdrawal group) or another step 5 asthma treatment (mepolizumab, benralizumab, daily oral steroids, bronchial thermoplasty); according to the pulmonologist's choice. The following categories will be considered: <300/mm3;≥300/mm3.
Measured: 12 months
Effect of OMA treatment duration on exacerbations
Effet of OMA treatment duration before randomization on exacerbations. 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. The following categories will be considered: 33-48 months / 49-63 months / more than 63 months
Measured: 12 months
Effect of OMA dosage on exacerbations
Effet of OMA dosage before randomization on exacerbations.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. The following categories will be considered: [150-300 mg/month]; ]300-600 mg/month];]600-900 mg/month] and ]900-1200 mg/month]
Measured: 12 months
Effect of eosinophils rate on exacerbations
Effet of OMA eosinophils rate at randomization on exacerbations. 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.The following categories will be considered: <300/mm3;≥300/mm3.
Measured: 12 months
Hospitalisation for asthma
Number of hospitalisations for asthma in the year following randomization.
Measured: 12 months
Emergency room visits for asthma
Emergency room visits for asthma in the year following randomization.
Measured: 12 months
St. George's Respiratory Questionnaire (SGRQ)
Changes in St. George's Respiratory Questionnaire (SGRQ). The SGRQ is self-administered and includes 50 items in three components: symptoms, activity, and impact on daily life. The SGRQ scores range from 0 to 100, with 0 indicating no impairment in the quality of life. Higher scores on the SGRQ indicating the worst quality of life. In cohort studies, a change of four points in the total score is considered clinically significant. Many studies have established that the SGRQ is a relevant, comprehensive and content-valid instrument to assess health status in patients with severe asthma.
Measured: 6 months
St. George's Respiratory Questionnaire (SGRQ)
Changes in St. George's Respiratory Questionnaire (SGRQ). The SGRQ is self-administered and includes 50 items in three components: symptoms, activity, and impact on daily life. The SGRQ scores range from 0 to 100, with 0 indicating no impairment in the quality of life. Higher scores on the SGRQ indicating the worst quality of life. In cohort studies, a change of four points in the total score is considered clinically significant. Many studies have established that the SGRQ is a relevant, comprehensive and content-valid instrument to assess health status in patients with severe asthma
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start20 May 2021
- Primary completion20 May 2027 (estimated)
- Study completion20 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Camille TAILLE, Professor, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763447
- Sponsor's protocol ID
- APHP180614
- Other IDs
- 2024-513427-17-00, 2020-000883-42
- Acronym
- SHORTEN
- Status last verified
- Nov 2024
- First submitted
- 17 Feb 2021
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Omalizumab Withdrawal After a 3 Year Duration Treatment in Well Controlled Severe Allergic Asthma : a Multicentric Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04763447
- Acronym / sponsor ID
- SHORTEN / APHP180614
- Conditions
- Asthma
- Keywords
- severe asthma, omalizumab, allergy, biologic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 20 May 2027 (estimated)
- Study completion
- 20 May 2027 (estimated)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Omalizumab (OMA) is a monoclonal anti IgE antibody, developed for severe uncontrolled allergic asthma. Efficacy of OMA in this indication is well documented in randomized trials as well as in real life studies, reducing the number of severe exacerbations by about 50% and improving asthma control score .
However, despite commercialized since 2006 in France, the optimal duration of the treatment remains unclear when asthma is well controlled. In particular, there is no guideline to apply the "step down theory" to biologics in well controlled patients.
It seems clear that a treatment given for less than one year is associated with an early relapse of the disease. However, in a randomized controlled study including 176 patients, stopping the treatment after 5 years induced a small, but acceptable loss of control (average decrease of asthma control test (ACT) by 2.88 and 1.16 point, p= 0.18), but some patients had uncontrolled asthma when the treatment was stopped. In a smaller cohort of 49 patients in Spain who voluntarily accepted to discontinue OMA treatment after 6 years of therapy, asthma deterioration (defined by one or more exacerbation and any Asthma Control Test change during the 1st year) was observed in 24% of patients during the first year following discontinuation , with a maximal rate of 2 exacerbations/yr. After 4 years of discontinuation, 60% of patients still take advantage of the 6 yrs of treatment with OMA. A retrospective study in France found that 14/26 patients treated for at least 3 years kept the same level of control after discontinuation. All these 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.
Inducing long term asthma remissions, rather than complete cure, is one potential goal of biologics. OMA is supposed to have disease modifying effects , explaining why there is a hope for a good asthma control being maintained after discontinuation. For this reason, French experts propose that omalizumab can be given for "3 to 5 yrs if asthma remains well controlled" . After an asthma relapse, OMA can be prescribed again theoretically, but no data regarding clinical response after a "second line" of treatment with the same biologic are available. The question of optimal treatment duration is also questioned with other biologics.
The costs related to OMA are high (estimated to 12 k€/year/patient). Frequent injections (1 subcutaneous injection every 4 weeks for the lowest dose to 4 injections every 2 weeks for the highest dose) represent severe constraints for patients, especially for the youngest ones. For all these reasons, evaluating whether shortening duration of OMA therapy is feasible while maintaining acceptable asthma control is a critical point. The main objective is to demonstrate the non-inferiority (i.e. no more exacerbations at 12 months) of OMA withdrawal attempt compared to OMA continuation in asthma-controlled patients treated for at least 33 months with OMA. Secondary objectives are to compare OMA withdrawal attempt versus OMA continuation in asthma-controlled patients treated for at least 33 months with OMA on other asthma control features at 6 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OMA withdrawal attempt | Experimental | Other: Attempt to withdrawal OMA treatmentPatients will be told to stop abruptly (no progressive decrease of the dose) their Omalizumab treatment and they will not be prescribed new OMA |
| OMA continuation | Active comparator | Drug: Continuation of OMA treatmentPatients will be prescribed the same dosage of Omalizumab than they received before randomization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Attempt to withdrawal OMA treatmentPatients will be told to stop abruptly (no progressive decrease of the dose) their Omalizumab treatment and they will not be prescribed new OMA. In case of loss of control, pulmonologist can adapt asthma treatment, as in usual care. In that case, OMA can be prescribed for a second line | Other | OMA withdrawal attempt |
| Continuation of OMA treatmentPatients will be prescribed the same dosage of Omalizumab than they received before randomization, according to their weight and total circulating IgE levels. In case of safety concerns or loss of control, pulmonologist can modify the patient treatment regimen of OMA or other co-medications, as in usual care. | Drug | OMA continuation |
Primary outcome
Number of exacerbations
Time frame: 12 months
Number of asthma exacerbations in the year following randomization. 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. They will be assessed every 6 months from patients log book, written reports of ER visits or hospitalizations, and prescriptions
37 secondary outcomes
Time to exacerbation
Time frame: 12 months
Asthma control (ACT)
Time frame: 6 months
Asthma control (ACT)
Time frame: 12 months
5 points-decrease of asthma control (ACT)
Time frame: 6 months
5 points-decrease of asthma control (ACT)
Time frame: 12 months
Time to loss of asthma control
Time frame: 12 months
Asthma quality of life (AQLQ)
Time frame: 6 months
Asthma quality of life (AQLQ)
Time frame: 12 months
Number of asthma controller drugs
Time frame: 6 months
Number of asthma controller drugs
Time frame: 12 months
Dose of inhaled steroids
Time frame: 6 months
Dose of inhaled steroids
Time frame: 12 months
Dose of oral steroids
Time frame: 6 months
Dose of oral steroids
Time frame: 12 months
Patients increasing their dose of oral steroids of 20%
Time frame: 6 months
Patients increasing their dose of oral steroids of 20%
Time frame: 12 months
Patients increasing their dose of oral steroids of 50%
Time frame: 6 months
Patients increasing their dose of oral steroids of 50%
Time frame: 12 months
Patients increasing their dose of oral steroids of 80%
Time frame: 6 months
Patients increasing their dose of oral steroids of 80%
Time frame: 12 months
Allergy manifestations
Time frame: 6 months
Allergy manifestations
Time frame: 12 months
FEV1
Time frame: 6 months
FEV1
Time frame: 12 months
Effect of OMA treatment duration on asthma control
Time frame: 12 months
Effect of OMA dosage on asthma control
Time frame: 12 months
Effect of eosinophils rate on asthma control
Time frame: 12 months
Effect of OMA treatment duration on time to loss of asthma control
Time frame: 12 months
Effect of OMA dosage on time to loss of asthma control
Time frame: 12 months
Effect of eosinophils rate on time to loss of asthma control
Time frame: 12 months
Effect of OMA treatment duration on exacerbations
Time frame: 12 months
Effect of OMA dosage on exacerbations
Time frame: 12 months
Effect of eosinophils rate on exacerbations
Time frame: 12 months
Hospitalisation for asthma
Time frame: 12 months
Emergency room visits for asthma
Time frame: 12 months
St. George's Respiratory Questionnaire (SGRQ)
Time frame: 6 months
St. George's Respiratory Questionnaire (SGRQ)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Individual participant dataSharing planned: Yes. Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Camille TAILLE, Professor principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Attempt to withdrawal OMA treatment and Continuation of OMA treatment in people with Asthma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Camille TAILLE, Professor (01 40 25 68 63 ext. +33, camille.taille@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of exacerbations (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.