NCT01420445

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Yuhan Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Bronchitis
• Chronic Bronchitis

Interventions

Type	Name	Description
DRUG	YHD001 dose level 1	three times daily / 7 days
DRUG	YHD001 dose level 2	three times daily / 7 days
DRUG	Pelargonium sidoides extract	6-9mL three times daily / 7 days
DRUG	placebo	three times daily / 7 days

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2011-08-19
• Last updated: 2013-09-26

Locations

1 site across 1 country: South Korea