A Multicenter, Randomized, Double-blind, Parallel Group Study to Determine the Optimal Dose of HL301 After 7 Days Oral Administration in Acute Bronchitis or Acute Exacerbations of Chronic Bronchitis Patients (HL301: Mixed Extract of Rehmannia Glutinosa, Schisandra and so on)

Acute Bronchitis Clinical Trial

— HL301  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02250027
• Other study ID #: HL_HL301_201
• Status: Completed
• Phase: Phase 2
• First received: September 2, 2014
• Last updated: September 25, 2014
• Start date: March 2014
• Est. completion date: July 2014

Study information

• Verified date: September 2014
• Source: Hanlim Pharm. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the optimal dose of HL301 in patients with acute bronchitis or acute exacerbations of chronic bronchitis.

• BSS(Bronchitis Severity Score), BCSS(Breathlessness, Cough, and Sputum Scale), evaluation of symptoms of cough and sputum

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Both gender, 19 years = age = 80 years

2. Acute bronchitis or acute exacerbations of chronic bronchitis patients with BSS(Bronchitis Severity Score)* = 5point at Visit1 and Visit2

3. Written consent voluntarily to participate in this clinical trial

Exclusion Criteria:

1. Patients who were increased the bleeding tendency

2. Patients with any of Alanine aminotransferase, Aspartate aminotransferase or serum Blood Urea Nitrogen, Creatinine> 2 times of the normal upper range

3. Patients who investigators determines to severe respiratory disease that would interfere with study assessment

4. Patients with COPD(Chronic Obstructive Pulmonary Disease) history of stage 3 or more

5. Patients who were treated with oral systemic adrenocortical hormone or immunosuppressive drug within 4 weeks prior to study participation

6. Patients who were treated with oral ß2-agonist, anticholinergic, Methylxanthine, antibiotics, antihistamines, sympathomimetic agent or oriental medicine/health functional food for antitussive and mucolytic Effect within 1 weeks prior to study participation

7. Patients who were treated with oral Antitussive, Mucolytic Agents,systemic antimicrobial agent within 3 days prior to study medication dosing

8. Patients with drug or alcohol abuse

9. Patients with clinically significant active liver, renal, cardiovascular, respiratory, endocrine, central nervous system disease or history of malignant tumor or mental illness(except no relapse for 5 years after surgery)

10. The aged person with severe medical history which is mental disorder(dementia), cancer, chronic renal failure, chronic liver failure

11. Pregnant or breast-feeding

12. Patients currently participating in or has participated in other clinical study within 30 days prior to study participation

13. Patients who investigators determines not appropriate to take part in this clinical study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Bronchitis
• Acute Disease
• Acute Exacerbations of Chronic Bronchitis
• Bronchitis
• Bronchitis, Chronic

Intervention

Drug:
• HL301 300mg capsule
2 capsules at once, 3 times a day, for 7 days
• Placebo
2 capsules at once, 3 times a day, for 7 days

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanlim Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bronchitis Severity Score	Bronchitis Severity Score	baseline(day 0) and day 7	No
Secondary	Breathlessness, Cough, and Sputum Scale	Breathlessness, Cough, and Sputum Scale	baseline(day 0) and day 7	No
Secondary	evaluation of symptoms of cough and sputum		baseline(day 0) and day 7	No
Secondary	Total usage of acetaminophen		baseline(day 0) and day 7	No