OMALIZUMAB for Severe allergic asthma|Allergic asthma

Inclusion criteria

• {"criterion_text":"- Adult patient >18 years old\n- Treated with OMA, prescribed by a pulmonologist, for at least 33 months for severe allergic asthma\n- 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 criteria

• {"criterion_text":"- Patient refusing to stop OMA treatment, whatever the reason\n- 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 …)\n- Patient not covered by Health Insurance\n- Patient under curatorship, guardianship or safeguarding of justice\n- Patient whose adherence to asthma treatments is considered poor or questionable by the investigator\n- Patient participating in another intervention research\n- Pregnant or lactating patient\n- Patient refusing to sign consent"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"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 as number of exacerbations occurring in the 12 months following randomization."}

Secondary endpoints

• {"endpoint_text":"- Changes in asthma control test (ACT) at 6 and 12 months. 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.","definition_or_measurement_approach":"ACT questionnaire (5 items) at 6 and 12 months; scores range 5-25; minimal clinically significant change = 5 points."}
• {"endpoint_text":"- Changes in asthma quality of life (AQLQ) and St. George's Respiratory Questionnaire (SGRQ) at 6 and 12 months.","definition_or_measurement_approach":"AQLQ and SGRQ scores at 6 and 12 months."}
• {"endpoint_text":"- Changes in FEV1 (in ml) at 6 and 12 months to assess respiratory function","definition_or_measurement_approach":"Change in FEV1 (ml) measured at 6 and 12 months."}
• {"endpoint_text":"- Changes in daily oral steroid dose at 6 and 12 months (percentage of variations, proportion of patients increasing their dose by ≥20%, ≥50%, ≥80%)","definition_or_measurement_approach":"Daily oral steroid dose changes assessed at 6 and 12 months; analyses include percent change and proportions with ≥20%, ≥50%, ≥80% increase."}
• {"endpoint_text":"- Changes in the number of asthma controller drugs at 6 and 12 months","definition_or_measurement_approach":"Number of controller medications recorded at 6 and 12 months."}
• {"endpoint_text":"- Changes in the mean daily dose (µg/j) of inhaled steroids received in the 3 previous months at 6 and 12 months","definition_or_measurement_approach":"Mean daily inhaled steroid dose (µg/day) averaged over the prior 3 months, measured at 6 and 12 months."}
• {"endpoint_text":"- Time to loss of asthma control defined by the number of days between the randomization and the prescription of OMA (in the withdrawal group) or another step 5 asthma treatment (mepolizumab, benralizumab, bronchial thermoplasty...); according to the pulmonologist's choice.","definition_or_measurement_approach":"Time (days) from randomization to prescription of OMA (if in withdrawal group) or another step 5 treatment as chosen by investigator."}
• {"endpoint_text":"- Time to exacerbation defined by the 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.","definition_or_measurement_approach":"Time (days) from randomization to first exacerbation using the same exacerbation definition as primary endpoint."}
• {"endpoint_text":"- Number of emergency room visits for asthma in the year following randomization","definition_or_measurement_approach":"Count of ER visits for asthma in the 12 months after randomization."}
• {"endpoint_text":"- Number of hospitalisations for asthma in the year following randomization","definition_or_measurement_approach":"Count of hospital admissions for asthma in the 12 months after randomization."}
• {"endpoint_text":"- Occurrence of deterioration of the asthma control (ACT) at 6 and 12 months, defined respectively by an ACT score at 6 and 12 months lower by 5 points or more compared to the ACT score at inclusion","definition_or_measurement_approach":"Deterioration defined as ACT decrease ≥5 points compared to baseline at 6 and 12 months."}
• {"endpoint_text":"- Effect of OMA treatment duration before randomization on asthma control, on time of loss of asthma and on exacerbations. The following categories will be considered: [33-48 months; 49-63 months; more than 63 months]","definition_or_measurement_approach":"Subgroup analyses by prior OMA treatment duration categories [33-48; 49-63; >63 months] on listed outcomes at 12 months."}
• {"endpoint_text":"- Effect of OMA dosage before randomization on asthma control, on time of loss of asthma and on exacerbations. The following categories will be considered: [150-300 mg/month]; ]300-600 mg/month];]600-900 mg/month] and ]900-1200 mg/month]","definition_or_measurement_approach":"Subgroup analyses by prior OMA dose categories ([150-300], (300-600], (600-900], (900-1200] mg/month) on listed outcomes."}
• {"endpoint_text":"- Effect of OMA eosinophils rate on asthma control, on time of loss of asthma and on exacerbations. The following categories will be considered: <300/mm3;≥300/mm3.","definition_or_measurement_approach":"Subgroup analyses by blood eosinophil count (<300/mm3 vs ≥300/mm3) on listed outcomes."}
• {"endpoint_text":"- Occurence of allergy manifestations (conjunctivitis, rhinitis, atopic dermatitis, food allergy (oral syndrome and anaphylactic reactions)) at 6 and 12 months","definition_or_measurement_approach":"Occurrence of specified allergic manifestations recorded at 6 and 12 months."}

France

Earliest CTIS Part Ii Submission Date

04-05-2024

Latest Decision Or Authorization Date

02-12-2025

Processing Time Days

577

Number Of Sites

44

Number Of Participants

234

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"French Ministry of Health and Solidarity","duties_or_roles":"Monetary support","organisation_type":""}