KCT0001239
Completed
未知
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.
Hanlim Pharmaceutical0 sites156 target enrollmentTBD
ConditionsDiseases of th respiratory system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of th respiratory system
- Sponsor
- Hanlim Pharmaceutical
- Enrollment
- 156
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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