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)

NCT02250027 | Completed Phase 2

• 1 other identifier: HL_HL301_201
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Bronchitis; Acute Exacerbations of Chronic Bronchitis

Keywords

acute bronchitis; acute exacerbations of chronic bronchitis

Outcome Measures

Primary Outcomes (1)

• Bronchitis Severity Score

  Bronchitis Severity Score

  baseline(day 0) and day 7

Secondary Outcomes (3)

• 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

Study Arms (4)

experimental A (0.6g/day)

EXPERIMENTAL

HL301 0.6g/day: 2 capsules at once, 3 times a day, for 7 days

Drug: HL301 300mg capsule; Drug: Placebo

experimental B (1.2g/day)

EXPERIMENTAL

HL301 1.2g/day: 2 capsules at once, 3 times a day, for 7 days

Drug: HL301 300mg capsule; Drug: Placebo

experimental C (1.8g/day)

EXPERIMENTAL

HL301 1.8g/day: 2 capsules at once, 3 times a day, for 7 days

Drug: HL301 300mg capsule

Placebo

PLACEBO COMPARATOR

placebo: 2 capsules at once, 3 times a day, for 7 days

Drug: Placebo

Interventions

HL301 300mg capsule DRUG

2 capsules at once, 3 times a day, for 7 days

Also known as: 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

experimental A (0.6g/day); experimental B (1.2g/day); experimental C (1.8g/day)

Placebo DRUG

2 capsules at once, 3 times a day, for 7 days

Also known as: Microcrystalline Cellulose

Placebo; experimental A (0.6g/day); experimental B (1.2g/day)

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanlim Pharm. Co., Ltd.: lead

Study Sites (1)

Kyung Hee University Hospital

Seoul, 130-872, South Korea

Location

MeSH Terms

Conditions

Bronchitis

Interventions

microcrystalline cellulose

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: September 26, 2014
• Study Start: March 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 26, 2014

Record last verified: 2014-09

Locations

KR (1)