Testing Safe Extension of Benralizumab Dosing Intervals

JRCT ID: jRCTs031240259

Registered date:06/08/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: asthma
• Date of first enrollment: 06/08/2024
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Benralizumab (trade name: Fasenra subcutaneous injection) will be administered as a 30 mg subcutaneous injection every 12 weeks.

Outcome(s)

• Primary Outcome: Annual asthma exacerbation rate (total number of exacerbations x 365.25 / total treatment period follow-up duration in days)

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Kaneko Takeshi