Acute Bronchitis, Chronic Bronchitis
Conditions
Brief 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.
Interventions
three times daily / 7 days
three times daily / 7 days
DRUGPelargonium sidoides extract
6-9mL three times daily / 7 days
DRUGplacebo
three times daily / 7 days
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of total symptom score from baseline to the end of treatment | 7 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| safety assessment | 7 days | comparison of the adverse event profiles throughout the course of the study, ECGs and safety blood tests on D0 and D7. |
| time to response | 7 days | — |
| compliance, defined by drug accountability | 7 days | — |
Countries
South Korea
Outcome results
None listed