Comparison of efficacy in pulmonary function of tiotropium / indacaterol and tiotropium / budesonide / formoterol in patients with COPD: Multicenter study.
Not Applicable
- Conditions
- Chronic obstructive pulmonary disease (COPD)
- Registration Number
- JPRN-UMIN000012046
- Lead Sponsor
- Division of Respiratory and Infectious Diseases, St. Marianna University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
Not provided
Exclusion Criteria
COPD with asthma Patients who are already treated with ICS or oral corticosteroid regularly Patients with a history of asthma Patients who have experienced a COPD exacerbation within the previous 8 weeks. Patients with uncontrolled cardiac diseases
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in FEV1 at 24 hours post dose (trough) before and after 8 weeks treatment.
- Secondary Outcome Measures
Name Time Method Improvements in the data of spirometry and IOS at 24 hours post dose (trough) before and after 8 weeks treatment. CAT score, transition dyspnea index (TDI), MMRC Exacerbations.