Adult patients with bronchial asthma
Conditions
Interventions
investigational material(s)
Generic name etc : KRP-108(FORMTEROL)
INN of investigational material :
Therapeutic category code : 225 Bronchodilators
Dosage and Administration for Investigational mater
Sponsors
Kyorin Pharmaceutical Co.,LTD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: The patients are not to be eligible for the study when they will fall into any of the following criteria. -Patients with complication or medical history of heart failure, myocardial infarction, angina, and the other heart disease. -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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FEV 1.0 value | — |
Secondary
| Measure | Time frame |
|---|---|
| Pulmonary function test values, PEF value,asthma symptom score, etc. | — |
Outcome results
None listed