Clinical Study of Fluticasone MDI in Adult Patients with Bronchial Asthma - Examination of Therapeutic Equivalence of Fluticasone MDI to Conventional Fluticasone MDI Preparation
- Conditions
- Adult patients with bronchial asthma
- Registration Number
- JPRN-jRCT2080220646
- Lead Sponsor
- Kyorin Pharmaceutical Co.,LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Adult patients with bronchial asthma who will meet all of the following criteria are to be enrolled in this study.
-Age: 16 years or more (at obtaining informed consent)
-Inpatient or outpatient: Not considered
-Disease severity: Mild to moderate
-Reversibility: Patients who present with the reversible air flow limitation
etc.
The patients are not to be eligible for the study when they will fall into any of the following criteria.
-Patients with a history of hypersensitivity to corticosteroids.
-Patients with complication of tuberculous disease, and respiratory infection, or medical history within one month before the run-in period
-Patients with complication of irreversible pulmonary disease including COPD, and pulmonary fibrosis
etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PEF value
- Secondary Outcome Measures
Name Time Method Pulmonary function test values,asthma symptom score, etc.