Trial to evaluate efficacy and safety of modified new drug of Pranlukast(Prakanon), compared with Pranlukast (Onon®)
- Conditions
- Diseases of th respiratory system
- Registration Number
- KCT0000457
- Lead Sponsor
- Ewha Womans University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
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
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
11) Recent 6 months' laboratory abnormalities in liver or renal function: more than 2 times of upper normal ranges in AST, ALT, BUN, and Cr
12) Other clinical trial medication within 3 months
13) Improper clinical situation or clinical illness, increasing risk during clinical trial under the study investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Group comparison on asthma control test(ACT) score
- Secondary Outcome Measures
Name Time Method Changes in ACT score upon questionnaires;Changes in QLQAKA score upon questionnaires;Changes in FEV1 from prebronchodilator FEV1 ;Changes in PEF from prebronchodilator PEF