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

Chronic Bronchitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01420445
• Other study ID #: YHD001-202
• Status: Completed
• Phase: Phase 2
• First received: July 20, 2011
• Last updated: September 25, 2013
• Start date: September 2011
• Est. completion date: May 2012

Study information

• Verified date: September 2013
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Bronchitis
• Acute Disease
• Bronchitis
• Bronchitis, Chronic
• Chronic Bronchitis

Intervention

Drug:
• YHD001 dose level 1
three times daily / 7 days
• YHD001 dose level 2
three times daily / 7 days
• Pelargonium sidoides extract
6-9mL three times daily / 7 days
• placebo
three times daily / 7 days

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea Seoul St. Mary'S Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of total symptom score from baseline to the end of treatment		7 days	No
Secondary	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	Yes
Secondary	time to response		7 days	No
Secondary	compliance, defined by drug accountability		7 days	No