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)

Phase 2

Completed

• Conditions: Acute Exacerbations of Chronic Bronchitis; Acute Bronchitis
• Interventions: Drug: HL301 300mg capsule; Drug: Placebo

• Registration Number: NCT02250027
• Lead Sponsor: Hanlim Pharm. Co., Ltd.

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-09
• Study First Submitted: 2014-09-02
• Study First Submitted QC: 2014-09-25
• Last Update Submitted: 2014-09-25
• Study First Posted: 2014-09-26
• Last Update Posted: 2014-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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 β2-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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental B (1.2g/day)	HL301 300mg capsule	HL301 1.2g/day: 2 capsules at once, 3 times a day, for 7 days
experimental A (0.6g/day)	HL301 300mg capsule	HL301 0.6g/day: 2 capsules at once, 3 times a day, for 7 days
Placebo	Placebo	placebo: 2 capsules at once, 3 times a day, for 7 days
experimental A (0.6g/day)	Placebo	HL301 0.6g/day: 2 capsules at once, 3 times a day, for 7 days
experimental B (1.2g/day)	Placebo	HL301 1.2g/day: 2 capsules at once, 3 times a day, for 7 days
experimental C (1.8g/day)	HL301 300mg capsule	HL301 1.8g/day: 2 capsules at once, 3 times a day, for 7 days

Primary Outcome Measures

Name	Time	Method
Bronchitis Severity Score	baseline(day 0) and day 7	Bronchitis Severity Score

Secondary Outcome Measures

Name	Time	Method
Breathlessness, Cough, and Sputum Scale	baseline(day 0) and day 7	Breathlessness, Cough, and Sputum Scale
Total usage of acetaminophen	baseline(day 0) and day 7
evaluation of symptoms of cough and sputum	baseline(day 0) and day 7

Trial Locations

Locations (1)

Kyung Hee University Hospital; 🇰🇷 Seoul, Korea, Republic of