Prospective study on identification of clinical predictive biomarkers and efficacy/safety of dupilumab for uncontrolled asthma

Prospective study on identification of clinical predictive biomarkers and efficacy/safety of dupilumab for uncontrolled asthma - J-DREAM

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000036337

Enrollment

Registered

2019-03-29

Start date

2019-03-29

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients diagnosed with bronchial asthma 2) Bronchial asthma patients who are uncontrolled even by existing treatment 3) Patients who obtain written consent regarding the participation of this study

Exclusion criteria

Exclusion criteria: 1) Patients who have previously received dupilumab 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

Measure	Time frame
Relationship between effect predictors before administration and improvement of symptoms and pulmonary function after 12 weeks	—

Secondary

Measure	Time frame
1. The time course of various effect predictors 2. 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)) 3. Effect of drug reduction scale 4. The incidence of adverse events of Grade 1 or higher during treatment 5. When continuing treatment with dupilumab after 12 weeks, adverse events from the onset of treatment of dupilumab to one year	—

Measure

Time frame

1. The time course of various effect predictors 2. 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)) 3. Effect of drug reduction scale 4. The incidence of adverse events of Grade 1 or higher during treatment 5. When continuing treatment with dupilumab after 12 weeks, adverse events from the onset of treatment of dupilumab to one year

—

Countries

Japan

Contacts

Public ContactTakehiro Izumo

Japanese Red Cross Medical Center Respiratory Medicine

drtake1118@gmail.com03-3400-1311

Outcome results