Prospective study on the identification of predictors of efficacy and efficacy/safety of twice-daily inhalers with three components in clinical practice for COPD patients (J-BRAVE)

Prospective study on the identification of predictors of efficacy and efficacy/safety of twice-daily inhalers with three components in clinical practice for COPD patients (J-BRAVE) - J-BRAVE

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000038169

Enrollment

100

Registered

2019-10-01

Start date

2019-10-01

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

COPD ACO

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with poor control who have already undergone COPD treatment with inhaled steroids, inhaled bronchodilators, inhaled anticholinergic drugs, or a combination of 2 drugs each 2) Patients who have obtained written consent for participation in this study

Exclusion criteria

Exclusion criteria: 1) Patients who have previously been treated with Breztri 2) Patients with serious complications such as heart disease / liver disease / renal disorder 3) Other patients who are judged to be inappropriate as a target by the doctor's judgment

Design outcomes

Primary

Measure	Time frame
Predictor identification of patients whose CAT score improved by 2 points or more after 12 weeks	—

Secondary

Measure	Time frame
1. Proportion of patients whose CAT score improved by 2 points or more after 12 weeks. 2. Percent improvement in respiratory function after 12 weeks 3. Incidence rate of Grade 1 or higher adverse events during treatment. 4. Incidence rate within 12 weeks 5. When continuing treatment with the drug after 12 weeks, adverse events, COPD control, and exacerbations from the start of treatment with the drug should be as much as possible.	—

Measure

Time frame

1. Proportion of patients whose CAT score improved by 2 points or more after 12 weeks. 2. Percent improvement in respiratory function after 12 weeks 3. Incidence rate of Grade 1 or higher adverse events during treatment. 4. Incidence rate within 12 weeks 5. When continuing treatment with the drug after 12 weeks, adverse events, COPD control, and exacerbations from the start of treatment with the drug should be as much as possible.

—

Countries

Japan

Contacts

Public ContactTakehiro Izumo

Japanese Red Cross Medical Canter Department of Respiratory Medicine

izumo_takehiro@med.jrc.or.jp0334001311

Outcome results