A prospective, randomized, open-label parallel-group clinical study to investigate effects and maneuverability of device of fluticasone/formoterol pMDI (Flutiform) vs. fluticasone/salmeterol DPI (Adoair Diskus) in patients who have poorly controlled asthma
Not Applicable
- Conditions
- Bronchial asthma
- Registration Number
- JPRN-UMIN000012330
- 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
- 24
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 FEV1 at week 2
- Secondary Outcome Measures
Name Time Method - ACQ - %FEV1, FEV1%, FEV1 - PEF - FeNO - Scores for Leicester Cough Questionnaire - Number of days when therapeutic drugs for asthma attacks are used, number of days when asthma symptoms are present, and asthma symptom score - Symptom score for cough - Questionnaire scores on inhaler (device maneuverability)