Phase 4 clinical trial to evaluate efficacy and safety of modified new drug of Pranlukast(Prakanon), compared with Pranlukast (Onon®)

Ewha Womans University Medical Center0 个研究点目标入组 40 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

暂无简介。

•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

发起方