A phase II, multicenter, randomized, double-blind, parallel group study to determine the optimal dose of HL301 after 7 days oral administration in acute bronchitis or acute exacerbations of chronic bronchitis patients.
- Conditions
- Diseases of th respiratory system
- Registration Number
- KCT0001239
- Lead Sponsor
- Hanlim Pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 156
1. both gender, 19 years = age = 80 years
2. acute bronchitis or acute exacerbations of chronic bronchitis patients with BSS(Bronchitis Severity Score)* = 5point at Visit1 and Visit2
3. Written consent voluntarily to participate in this clinical trial
1. Patients who were increased the bleeding tendency
2. Patients with any of ALT, AST or serum BUN, Creatinine> 2 times of the normal upper range
3. Patients who investigators determines to severe respiratory disease that would interfere with study assessment
4. Patients with COPD history of stage 3 or more
5. Patients who were treated with oral systemic adrenocortical hormone or immunosuppressive drug whithin 4 weeks prior to study participation
6. Patients who were treated with oral ß2-agonist, anticholinergic, Methylxanthine, antibiotics, antihistamines, sympathomimetic agent or oriental medicine/health functional food for antitussive and mucolytic Effect whithin 1 weeks prior to study participation
7. Patients who were treated with oral Antitussive, Mucolytic Agents,systemic antimicrobial agent whithin 3 days prior to study medication dosing
8. Patients with drug or alcohol abuse
9. Patients with clinically significant active liver, renal, cardiovascular, respiratory, endocrine, central nervous system disease or history of malignant tumor or mental illness(except no relapse for 5 years after surgery)
10. The aged person with severe medical history which is mental disorder(dementia), cancer, chronic renal failure, chronic liver failure
11. Pregnant or breast-feeding
12. Patients currently participating in or has participated in other clinical study within 30 days prior to study participation
13. Patients who investigators determines not appropriate to take part in this clinical study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bronchitis Severity Score (BSS)
- Secondary Outcome Measures
Name Time Method Breathlessness, Cough, and Sputum Scale;evaluation of symptoms of cough and sputum;Total usage of Acetaminophen