Safety/Tolerability and Efficacy of YHD001 in Patients With Acute and Chronic Bronchitis

Study Overview
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Brief Summary
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The study will conduct with 4 comparative groups orally treated with YHD001 dose level 1(t.i.d.), YHD001 dose level 2(t.i.d.), pelargonium sidoides extract 9mL(t.i.d.) or Placebo for 7 days. The treatments will be assigned randomly to patients (n=116) with acute or chronic bronchitis.

Detailed Description
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The outcome measures is to evaluate the overall change from baseline to the end of treatment in scores relating to the severity of four symptom of bronchitis: cough, sputum, QOL of daily life, QOL of falling asleep at night.

Official Title
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Randomized, Double-blind, Placebo/Active-controlled, Multi-center, Phase 3 Clinical Trial to Investigate the Safety/Tolerability and Efficacy of YHD001 After Oral Administration in Patients With Acute or Chronic Bronchitis

Conditions
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Acute Bronchitis, Chronic Bronchitis

Intervention / Treatment
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* Drug: YHD001 dose level 1
* Drug: YHD001 dose level 2
* Drug: Pelargonium sidoides extract
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients aged ≥18 year Provision of written informed consent Acute bronchitis with a Bronchitis Severity Score(BSS)≥five points Exclusion Criteria: History of any clinically significant disease History of drug/chemical/alcohol abuse Use of antibiotics, anti-histamine during the 7 days before administration of the investigational product

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YHD001 dose level 1<br>YHD001 dose level 1 | Drug: YHD001 dose level 1<br>* three times daily / 7 days<br>* Other names: Undecided;|
| Experimental: YHD001 dose level 2<br>YHD001 dose level 2 | Drug: YHD001 dose level 2<br>* three times daily / 7 days<br>* Other names: Undecided;|
| Active Comparator: Pelargonium sidoides extract<br>Pelargonium sidoides extract (Syrup) | Drug: Pelargonium sidoides extract<br>* 6-9mL three times daily / 7 days<br>* Other names: UMCKAMIN Syrup;|
| Placebo Comparator: Placebo<br>Placebo for YHD001 & active comparator(syrup) | Drug: placebo<br>* three times daily / 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of total symptom score from baseline to the end of treatment |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety assessment | comparison of the adverse event profiles throughout the course of the study, ECGs and safety blood tests on D0 and D7. | 7 days | 
| time to response |  | 7 days | 
| compliance, defined by drug accountability |  | 7 days |