asthma asthma
Conditions
Interventions
Benralizumab (trade name: Fasenra subcutaneous injection) will be administered as a 30 mg subcutaneous injection every 12 weeks.
D018927
Sponsors
Kobayashi Nobuaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (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.
Exclusion criteria
Exclusion criteria: (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annual asthma exacerbation rate (total number of exacerbations x 365.25 / total treatment period follow-up duration in days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Endpoints: Asthma Control Questionnaire (ACQ) score, comprising 7 items assessing asthma-related symptoms Forced Expiratory Volume in 1 second (FEV1) Peripheral blood eosinophil count Fractional exhaled nitric oxide (FeNO) Oral corticosteroid (OCS) dose Changes in asthma controller medication Safety Endpoint: Adverse events | — |
Contacts
Public ContactNobuaki Kobayashi
Yokohama City University Hospital
Outcome results
None listed