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)

Sponsor

Hanlim Pharm. Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT02250027

Collaborator

(none)

156

Enrollment

Location

Arms

Duration (Months)

38.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Acute Bronchitis Acute Exacerbations of Chronic Bronchitis	Drug: HL301 300mg capsule Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

156 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Study Start Date :

Mar 1, 2014

Actual Primary Completion Date :

Jul 1, 2014

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Bronchitis Severity Score [baseline(day 0) and day 7]
Bronchitis Severity Score

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Both gender, 19 years ≤ age ≤ 80 years
Acute bronchitis or acute exacerbations of chronic bronchitis patients with BSS(Bronchitis Severity Score)* ≥ 5point at Visit1 and Visit2
Written consent voluntarily to participate in this clinical trial

Exclusion Criteria:

Patients who were increased the bleeding tendency
Patients with any of Alanine aminotransferase, Aspartate aminotransferase or serum Blood Urea Nitrogen, Creatinine> 2 times of the normal upper range
Patients who investigators determines to severe respiratory disease that would interfere with study assessment
Patients with COPD(Chronic Obstructive Pulmonary Disease) history of stage 3 or more
Patients who were treated with oral systemic adrenocortical hormone or immunosuppressive drug within 4 weeks prior to study participation
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
Patients who were treated with oral Antitussive, Mucolytic Agents,systemic antimicrobial agent within 3 days prior to study medication dosing
Patients with drug or alcohol abuse
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)
The aged person with severe medical history which is mental disorder(dementia), cancer, chronic renal failure, chronic liver failure
Pregnant or breast-feeding
Patients currently participating in or has participated in other clinical study within 30 days prior to study participation
Patients who investigators determines not appropriate to take part in this clinical study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kyung Hee University Hospital	Seoul		Korea, Republic of	130-872

Sponsors and Collaborators

Hanlim Pharm. Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hanlim Pharm. Co., Ltd.

ClinicalTrials.gov Identifier:

NCT02250027

Other Study ID Numbers:

HL_HL301_201

First Posted:

Sep 26, 2014

Last Update Posted:

Sep 26, 2014

Last Verified:

Sep 1, 2014

Keywords provided by Hanlim Pharm. Co., Ltd.

acute bronchitis

acute exacerbations of chronic bronchitis

Additional relevant MeSH terms:

Bronchitis

Bronchitis, Chronic

Acute Disease

Study Results

No Results Posted as of Sep 26, 2014