KCT0000457
Recruiting
未知
Phase 4 clinical trial to evaluate efficacy and safety of modified new drug of Pranlukast(Prakanon), compared with Pranlukast (Onon®)
ConditionsDiseases of th respiratory system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of th respiratory system
- Sponsor
- Ewha Womans University Medical Center
- Enrollment
- 40
- Status
- Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Mild to moderate persistent partially controlled asthma
- •2\) Partially uncontrolled asthma with a ACT score less than 20, under more than 4 weeks trial of inhaled corticosteroid or combined long acting beta agonist
- •3\) Smoking history less than 20 pack year
- •4\) Normal chest PA and minor radiologic changes not affecting to lung function
- •5\) An agreement to informed consent
Exclusion Criteria
- •1\) Other causes of pulmonary function abnormality except asthma: COPD, bronchiectasis, cystic fibrosis, bronchopulmonary dysplasia
- •2\) Recent bacterial or viral upper/lower respiratory infection, less than 4 weeks prior to screening day
- •3\) Congestive heart failure, severe liver functional abnormality, severe renal impairment
- •4\) A past history of lung resection operation
- •5\) A past history or current illness of malignant neoplasm
- •6\) Life threatening history due to asthma: in last 5 years, intubation, severe hypercapnia, respiratory arrest or hypoxemic attack.
- •7\) Recent administration of following medication prior to clinical trial: leukotriene modifier, systemic corticosteroid, or drug affecting CYP3A4 inhibitor or catecholamines.
- •8\) A patient during pregnancy or breast feeding
- •9\) A history of hypersensitivity to the component of clinical trial medication(Pranlukast hydrate, Beta 2 agonist, steroids)
- •10\) A genetic problem of galactose intolerance, Lapp lactase deficiency, or glucose\-galactose malabsorption
Outcomes
Primary Outcomes
Not specified
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