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)

Not Applicable

Recruiting

• Conditions: COPD ACO

• Registration Number: JPRN-UMIN000038169
• Lead Sponsor: Japanese Red Cross Medical Canter

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-01
• Last Update Posted: 17 October 2023
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predictor identification of patients whose CAT score improved by 2 points or more after 12 weeks

Secondary Outcome Measures

Name	Time	Method
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.