Efficacy, equivalence and operability of switching to a combination of budesonide, glycopyrronium, and formoterol in patients with COPD and ACO
Phase 4
Recruiting
- Conditions
- COPD
- Registration Number
- JPRN-UMIN000049879
- Lead Sponsor
- Kindai University Nara Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Not provided
Exclusion Criteria
1) Under 40 years old 2) Patients who have difficulty inhaling by theirself 3) Patients for whom the physician determines that pulmonary function testing is impossible or inaccurate for any reason (e.g., hearing loss, pregnancy, etc.) 4) Patients whose QoL or lung function may be affected during the study period, as determined by the physician: e.g., patients with end-stage cancer, severe heart failure, liver cirrhosis, respiratory failure, etc. 5) Patients who cannot use ICS or LABA or LAMA
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy, adverse events, inhalation maneuverability, and adherence before and after switching to Breztri (a combination of budesonide, glycopyrronium, and formoterol) in patients with COPD or ACO requiring an ICS, LABA, and LAMA.
- Secondary Outcome Measures
Name Time Method Comparison with Trelegy in patients switching from Trelegy