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Prospective study on identification of effectiveness, safety and effect predictors of benralizumab for bronchial asthma

Prospective study on identification of effectiveness, safety and effect predictors of benralizumab for bronchial asthma - J-BEST

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000031951
Enrollment
25
Registered
2018-03-28
Start date
2018-04-18
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bronchial asthma

Interventions

None listed

Sponsors

Japanese Red Cross Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients diagnosed with bronchial asthma according to general allergy guideline 2016 2) Patients with bronchial asthma using high-dose inhaled corticosteroids and long-acting beta 2 agonists 3) Patients who obtain written consent regarding the participation of this study

Exclusion criteria

Exclusion criteria: 1) Patients who have previously received benralizumab 2) Patients with severe complications such as heart disease, liver disease or kidney failure 3) Patients judged unsuitable as subjects by doctor's judgment

Design outcomes

Primary

MeasureTime frame
Relationship between effect predictors before administration and improvement of symptoms after 12 weeks

Secondary

MeasureTime frame
1. Improvement of questionnaire on quality of life (AQLQ), asthma control test (ACT) score, exacerbation frequency, respiratory function one second amount (FEV 1), divided into two groups at the median of various effect predicting factors before administration 2. The relationship between the variation of various indices and the improvement of AQLQ score, ACT score, exacerbation frequency, FEV 1 3. The time course of various effect predictors 4. Asthma control (the ratio of the number of strokes up to the 12th week, the ratio of unscheduled outpatient visits to the 12th week (including emergency outpatient visits)) 5. Effect of drug reduction scale 6. The incidence of adverse events of Grade 1 or higher during treatment 7. When continuing treatment with benralizumab after 12 weeks, adverse events from the onset of treatment of benralizumab to one year

Countries

Japan

Contacts

Public ContactTakehiro Izumo

Japanese Red Cross Medical Center Respiratory Medicine

drtake1118@gmail.com03-3400-1311

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026