Phase III Significance Study of KRP-AB1102F DPI
Phase 3
- Conditions
- COPD
- Registration Number
- JPRN-jRCT2080222230
- Lead Sponsor
- Kyorin Pharmaceutical Co.,LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 600
Inclusion Criteria
COPD patients with post-bronchodilator FEV1 between 30 and 80 % of predicted
Exclusion Criteria
- History or current diagnosis of asthma
-Patient hospitalized for an acute COPD exacerbation within 3 months prior to screening visit, and others.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Trough FEV1<br>The change from baseline in trough FEV1 at Week 12
- Secondary Outcome Measures
Name Time Method 1h Post dose FEV1<br>The change from baseline in 1 h post dose FEV1 at Week 12