Evaluation of the effect of switching from LAMA / LABA therapy to ICS-containing triple therapy (ICS/LAMA/LABA) in patients with COPD. single center, real world study
Not Applicable
Recruiting
- Conditions
- Chronic obstructive pulmonary disease
- Registration Number
- JPRN-UMIN000040764
- Lead Sponsor
- Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
Excluded from the study were those with a documented history of asthma, a bronchodilator response (BDR) to 400 microgram salbutamol shown as a FEV1 change of and or more than 200 ml or peripheral eosinophilia more than 150, presence of typical asthma symptoms of atopy or history of IgE more than 170IU/ml and those confirmed to have received LAMA, LABA or ICS other than the study drug or their combination.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The change in airway pathology, i.e., change in FEV1 at week 4 on spirometry and respiratory resistance (both expiratory and inspiratory resistance) using a MOST graph on impulse oscillometry (IOS)
- Secondary Outcome Measures
Name Time Method COPD Assessment Test (CAT) scores, modified Medical Research Council (mMRC) Dyspnea Scale scores, St. George's Respiratory Questionnaire (SGRQ) scores, Short Form (36) Health Survey (SF-36) scores, and study drug safety.