JRCT ID: jRCTs031240259
Registered date:06/08/2024
Testing Safe Extension of Benralizumab Dosing Intervals
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | asthma |
Date of first enrollment | 22/11/2024 |
Target sample size | 30 |
Countries of recruitment | |
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) |
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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 |
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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 |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Nobuaki Kobayashi |
Address | 3-9 Fukuura Kanazawaku Yokohama Kanagawa Kanagawa Japan 236-0004 |
Telephone | +81-45-787-2800 |
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 |
takeshi@yokohama-cu.ac.jp | |
Affiliation | Yokohama City University Hospital |