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

NCT01420445 Phase 2 COMPLETED

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.

Details

Lead sponsor	Yuhan Corporation
Phase	Phase 2
Status	COMPLETED
Enrolment	118
Start date	2011-09
Completion	2012-05

Conditions

• Acute Bronchitis
• Chronic Bronchitis

Interventions

• YHD001 dose level 1
• YHD001 dose level 2
• Pelargonium sidoides extract
• placebo

Primary outcomes

• Change of total symptom score from baseline to the end of treatment — 7 days

Countries

South Korea