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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanlim Pharm. Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02250027
First received: September 2, 2014
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Acute Bronchitis
Acute Exacerbations of Chronic Bronchitis
Drug: HL301 300mg capsule
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hanlim Pharm. Co., Ltd.:

Primary Outcome Measures:
  • Bronchitis Severity Score [ Time Frame: baseline(day 0) and day 7 ]
    Bronchitis Severity Score


Secondary Outcome Measures:
  • Breathlessness, Cough, and Sputum Scale [ Time Frame: baseline(day 0) and day 7 ]
    Breathlessness, Cough, and Sputum Scale

  • evaluation of symptoms of cough and sputum [ Time Frame: baseline(day 0) and day 7 ]
  • Total usage of acetaminophen [ Time Frame: baseline(day 0) and day 7 ]

Enrollment: 156
Study Start Date: March 2014
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Microcrystalline Cellulose

  Eligibility

Ages Eligible for Study:   19 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02250027

Locations
Korea, Republic of
Kyung Hee University Hospital
Seoul, Korea, Republic of, 130-872
Sponsors and Collaborators
Hanlim Pharm. Co., Ltd.
  More Information

Responsible Party: Hanlim Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT02250027     History of Changes
Other Study ID Numbers: HL_HL301_201
Study First Received: September 2, 2014
Last Updated: September 25, 2014

Keywords provided by Hanlim Pharm. Co., Ltd.:
acute bronchitis
acute exacerbations of chronic bronchitis

Additional relevant MeSH terms:
Bronchitis
Acute Disease
Bronchitis, Chronic
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on March 29, 2017