Testing Safe Extension of Benralizumab Dosing Intervals (BENEFIT trial)
- Conditions
- asthma
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
(1) Diagnosis of bronchial asthma and continuous treatment with benralizumab for at least 1 year prior to study initiation. (2) No more than 1 asthma exacerbation in the past year. (3) No asthma exacerbations within the past 3 months. (4) No increase in controller medication dosage due to symptom worsening in the past year (dose reductions or discontinuations of controllers are permitted). (5) Age 18 years or older. (6) Provision of written informed consent to participate in this study.
(1) Current or prior use of other biologic agents for asthma within the past 1 year. (2) History of severe asthma exacerbation requiring mechanical ventilation. (3) Pregnant or lactating women, those with a possibility of being pregnant, or those who desire to become pregnant during the treatment period. (4) Patients with a potential for parasitic infection. (5) Any other patients deemed ineligible for the study based on the investigator's clinical judgment.
Study & Design
- Study Type
- Interventional
- Study Design
- single assignment
- Primary Outcome Measures
Name Time Method Annual asthma exacerbation rate Annual Total number of exacerbations × 365.25 / total treatment period follow-up duration in days
- Secondary Outcome Measures
Name Time Method Asthma Control Questionnaire (ACQ) score comprising 7 items assessing asthma-related symptoms