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

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yuhan Corporation

Criteria

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