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) (HL301)

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

Study Overview

• Status: Completed
• Conditions: Acute Exacerbations of Chronic Bronchitis; Acute Bronchitis
• Intervention / Treatment: Drug: HL301 300mg capsule; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 130-872
    • Kyung Hee University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental A (0.6g/day); HL301 0.6g/day: 2 capsules at once, 3 times a day, for 7 days	Drug: HL301 300mg capsule; 2 capsules at once, 3 times a day, for 7 days; Other Names: experimental A (0.6g/day) : HL301 300mg 2 capsule; experimental B (1.2g/day) : HL301 300mg 4 capsule; experimental C (1.8g/day) : HL301 300mg 6 capsule; Drug: Placebo; 2 capsules at once, 3 times a day, for 7 days; Other Names: Microcrystalline Cellulose
Experimental: experimental B (1.2g/day); HL301 1.2g/day: 2 capsules at once, 3 times a day, for 7 days	Drug: HL301 300mg capsule; 2 capsules at once, 3 times a day, for 7 days; Other Names: experimental A (0.6g/day) : HL301 300mg 2 capsule; experimental B (1.2g/day) : HL301 300mg 4 capsule; experimental C (1.8g/day) : HL301 300mg 6 capsule; Drug: Placebo; 2 capsules at once, 3 times a day, for 7 days; Other Names: Microcrystalline Cellulose
Experimental: experimental C (1.8g/day); HL301 1.8g/day: 2 capsules at once, 3 times a day, for 7 days	Drug: HL301 300mg capsule; 2 capsules at once, 3 times a day, for 7 days; Other Names: experimental A (0.6g/day) : HL301 300mg 2 capsule; experimental B (1.2g/day) : HL301 300mg 4 capsule; experimental C (1.8g/day) : HL301 300mg 6 capsule
Placebo Comparator: Placebo; placebo: 2 capsules at once, 3 times a day, for 7 days	Drug: Placebo; 2 capsules at once, 3 times a day, for 7 days; Other Names: Microcrystalline Cellulose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bronchitis Severity Score	Bronchitis Severity Score	baseline(day 0) and day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breathlessness, Cough, and Sputum Scale	Breathlessness, Cough, and Sputum Scale	baseline(day 0) and day 7
evaluation of symptoms of cough and sputum		baseline(day 0) and day 7
Total usage of acetaminophen		baseline(day 0) and day 7

Collaborators and Investigators

• Sponsor: Hanlim Pharm. Co., Ltd.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: September 2, 2014
• First Submitted That Met QC Criteria: September 25, 2014
• First Posted (Estimate): September 26, 2014

Study Record Updates

• Last Update Posted (Estimate): September 26, 2014
• Last Update Submitted That Met QC Criteria: September 25, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: acute bronchitis; acute exacerbations of chronic bronchitis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Bronchial Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Acute Disease; Bronchitis; Bronchitis, Chronic
• Other Study ID Numbers: HL_HL301_201