A prospective, randomized, open-label parallel-group clinical study to investigate effects of fluticasone/formoterol pMDI (Flutiform) vs fluticasone/salmeterol DPI (Adoair Diskus) or pMDI (Adoair Aerosol) in asthmatic patients with small airway inflammatio
Not Applicable
- Conditions
- Bronchial asthma
- Registration Number
- JPRN-UMIN000012332
- Lead Sponsor
- KYORIN Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
(1) Patients who have experienced adverse drug reactions caused by treatment with an ICS, LABA, or concomitant use or a combination of ICS and LABA (2) Patients with severe cardiac, hepatic, renal, pulmonary, or hematologic disease (3) Patients with complications of apparent chronic obstructive pulmonary disease (COPD) (4) Patients with complications of malignant tumors (5) Patients with a history of smoking within the past 1 year (6) Patients who are pregnant, lactating, or desire to conceive during the study period (7) Patients who were judged unsuitable for enrollment in the study by the investigator or the sub-investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of R5-R20 at week 4 measured by IOS
- Secondary Outcome Measures
Name Time Method - R5, R20, R5-R20, X5, and Ax measured by IOS - FeNO - FEV1, %FEV1, FEV1%, V25, and V50 - ACQ