NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031240259

Registered date:06/08/2024

Testing Safe Extension of Benralizumab Dosing Intervals

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedasthma
Date of first enrollment22/11/2024
Target sample size30
Countries of recruitment
Study typeInterventional
Intervention(s)Benralizumab (trade name: Fasenra subcutaneous injection) will be administered as a 30 mg subcutaneous injection every 12 weeks.

Outcome(s)

Primary OutcomeAnnual asthma exacerbation rate (total number of exacerbations x 365.25 / total treatment period follow-up duration in days)
Secondary OutcomeEfficacy 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 maximumNot applicable
GenderBoth
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

Contact

Public contact
Name Nobuaki Kobayashi
Address 3-9 Fukuura Kanazawaku Yokohama Kanagawa Kanagawa Japan 236-0004
Telephone +81-45-787-2800
E-mail nkobayas@yokohama-cu.ac.jp
Affiliation Yokohama City University Hospital
Scientific contact
Name Takeshi Kaneko
Address 3-9 Fukuura Kanazawaku Yokohama Kanagawa Kanagawa Japan 236-0004
Telephone +81-45-787-2800
E-mail takeshi@yokohama-cu.ac.jp
Affiliation Yokohama City University Hospital