Trial to evaluate efficacy and safety of modified new drug of Pranlukast(Prakanon), compared with Pranlukast (Onon®)

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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0000457

Enrollment

Registered

2012-06-08

Start date

2011-07-12

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug, Radiation : The patients were divided into two groups by pre-assigned random tables. Group 1: Twenty patients received Onon® 450mg/day, bid(1 time 112.5mg X 2Cap) for 8 weeks. One week rests wit

Eligibility

Sex/Gender

All

Inclusion 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

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 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

Design outcomes

Primary

Measure	Time frame
Group comparison on asthma control test(ACT) score	—

Secondary

Measure	Time frame
Changes in ACT score upon questionnaires;Changes in QLQAKA score upon questionnaires;Changes in FEV1 from prebronchodilator FEV1 ;Changes in PEF from prebronchodilator PEF	—

Countries

Korea, Republic of

Contacts

Public ContactJung Chang

Ewha Womans University Medical Center

Outcome results