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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02250027
Other study ID # HL_HL301_201
Secondary ID
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


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
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