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

Phase 2

Completed

• Conditions: Acute Bronchitis; Chronic Bronchitis
• Interventions: Drug: YHD001 dose level 1; Drug: YHD001 dose level 2; Drug: Pelargonium sidoides extract; Drug: placebo

• Registration Number: NCT01420445
• Lead Sponsor: Yuhan Corporation

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2011-07-20
• Study First Submitted QC: 2011-08-18
• Study First Posted: 2011-08-19
• Study Start: 2011-09
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-25
• Last Update Posted: 2013-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
YHD001 dose level 1	YHD001 dose level 1	YHD001 dose level 1
YHD001 dose level 2	YHD001 dose level 2	YHD001 dose level 2
Pelargonium sidoides extract	Pelargonium sidoides extract	Pelargonium sidoides extract (Syrup)
Placebo	placebo	Placebo for YHD001 \& active comparator(syrup)

Primary Outcome Measures

Name	Time	Method
Change of total symptom score from baseline to the end of treatment	7 days

Secondary Outcome Measures

Name	Time	Method
safety assessment	7 days	comparison of the adverse event profiles throughout the course of the study, ECGs and safety blood tests on D0 and D7.
time to response	7 days
compliance, defined by drug accountability	7 days

Trial Locations

Locations (1)

The Catholic University of Korea Seoul St. Mary'S Hospital; 🇰🇷 Seoul, Korea, Republic of