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

Yuhan

Status and phase: Completed; Phase 2

Conditions: Chronic Bronchitis; Acute Bronchitis

Treatments: Drug: YHD001 dose level 2; Drug: YHD001 dose level 1; Drug: placebo; Drug: Pelargonium sidoides extract

Study type: Interventional

Funder types: Industry

Identifiers

NCT01420445

YHD001-202

Details and patient eligibility

About

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.

Full 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.

Enrollment: 118 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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118 participants in 4 patient groups, including a placebo group

YHD001 dose level 1

Experimental group

Description:

YHD001 dose level 1

Treatment:

Drug: YHD001 dose level 1

YHD001 dose level 2

Experimental group

Description:

YHD001 dose level 2

Treatment:

Drug: YHD001 dose level 2

Pelargonium sidoides extract

Active Comparator group

Description:

Pelargonium sidoides extract (Syrup)

Treatment:

Drug: Pelargonium sidoides extract

Placebo

Placebo Comparator group

Description:

Placebo for YHD001 \& active comparator(syrup)

Treatment:

Drug: placebo