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Efficacy and Safety of GHX02 in the Treatment of Acute Bronchitis

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ClinicalTrials.gov Identifier: NCT03310385
Recruitment Status : Not yet recruiting
First Posted : October 16, 2017
Last Update Posted : October 17, 2017
Sponsor:
Information provided by (Responsible Party):
Yang Chun Park, Daejeon University

Brief Summary:
This study is a phase 2, multicentre, dose-finding, double-blind, randomized placebo-controlled trial to evaluate the efficacy and safety of two different doses of GHX02, compared with placebo, for acute bronchitis. One-hundred and fifty patients will be included in this trial and randomly assigned to either a high-dose GHX02 group(1920mg/day), standard-dose GHX02 group(960mg/day), or control group(placebo) in a 1:1:1 allocation ratio. Patients will take one of the medications three times a day for 7 days, with 3 visiting days(screening, day0, day7). On the screening day, the Korean Standard Tool of Pattern Identification of Cough and Sputum, a diagnostic system that determines therapy in Traditional Korean Medicine, will be used to allocate patients into three groups of wind-heat, wind-cold or others.

Condition or disease Intervention/treatment Phase
Acute Bronchitis Drug: GHX02 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: multicentre, dose-finding,double-blind, randomized placebo-controlled trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: double-blind
Primary Purpose: Treatment
Official Title: Efficacy and Safety of GHX02 in the Treatment of Acute Bronchitis: a Phase 2, Double-blind, Randomized Placebo-controlled Trial
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acute Bronchitis

Arm Intervention/treatment
Experimental: High-dose GHX02 group(1,920mg/day)
4 tablets of the GHX02, three times daily for 7 days
Drug: GHX02
Herbal medicine originating from gualouhengryunhwan

Experimental: Standard-dose GHX02 group(960mg/day)
2 tablets of the GHX02 and 2 tablets of the placebo, three times daily for 7 days
Drug: GHX02
Herbal medicine originating from gualouhengryunhwan

Drug: Placebo
Placebo tablets

Placebo Comparator: Placebo control
4 tablets of the placebo, three times daily for 7 days
Drug: Placebo
Placebo tablets




Primary Outcome Measures :
  1. Change in BSS(Bronchitis Severity Score) [ Time Frame: Day0, Day7 ]
    BSS comprises the sum of five major symptom scores for acute bronchitis: cough, sputum, dyspnea, chest pain during coughing, and rales on auscultation. Each symptom is scored on a 4-point-scale (0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe), with a maximum total score of 20 points. The investigator assesses symptom scores on the basis of the patient's subjective symptoms.


Secondary Outcome Measures :
  1. Change in Questionnaire of Clinical Symptoms of Cough and Sputum [ Time Frame: Day0, Day7 ]
    Questionnaire items are as follows: (1) cough -frequency, intensity, sensitivity; (2) sputum -frequency, volume, difficulty to cough-up, appearance, color; (3) activities of daily living; (4) night-time sleeping. Each item is scored on a 4-point-scale, with a total maximum score of 40 points.

  2. Change in Leicester Cough Questionnaire-acute(LCQ-acute) [ Time Frame: Day0, Day7 ]
    It consists of 19 items divided into three parts, physical, psychological, and social, each scored from 1 to 7. The total score is the sum of the average scores(1-7 points) for each part. The higher the score, the better the quality of life.

  3. Change in frequency of coughing fits [ Time Frame: Day0, Day1, Day2, Day3, Day4, Day5, Day6, Day7 ]
    participants will be classified into one of the following scales: 0 = 0 time/day, 1 = 1 time/day, 2 = 2-3 times/day, 3 = 4-5 times/day(sometimes), 4 = 6-10 times/day(frequent), 5 = over 15 times/day(consistently).

  4. Integrative Medicine Outcome Scale(IMOS) [ Time Frame: Day7 ]
    It's a 5-point-scale for evaluating improvement after treatment (where, 1=complete recovery, 2=major improvement, 3=slight-to-moderate improvement, 4=no change, 5=deterioration), either by the patient or investigator (the investigator in this trial).

  5. Integrative Medicine Patient Satisfaction Scale(IMPSS) [ Time Frame: Day7 ]
    It's a 5-point-scale for evaluating patient satisfaction with the treatment (where, 1=very satisfied, 2=satisfied, 3=neutral, 4=dissatisfied, 5=very dissatisfied)



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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age 19-75 years
  2. BSS ≥ 5 points at visit2 due to acute bronchitis
  3. symptoms starting within 2 weeks before study inclusion
  4. patients who consent to participate

Exclusion Criteria:

  1. pregnant or breast-feeding
  2. treatment with antibiotics, bronchodilators, glucocorticoids, immune-depressants, or other clinical trial medicines during the last 4 weeks before study inclusion
  3. treatment with antitussives or expectorants during the last 7 days before study inclusion
  4. history or presence of confounding respiratory disease that may affect evaluation of the efficacy of clinical medicine (e.g. chronic bronchitis, chronic obstructive pulmonary disease (COPD), bronchiectasis, asthma, pneumonia, cystic fibrosis, lung cancer, or active pulmonary tuberculosis)
  5. liver or renal impairment (alanine aminotransferase(ALT), aspartate aminotransferase(AST), alkaline phosphatase(ALP) ≥ 3 times the normal upper limit, or creatinine> 3.0 mg/dL at screening)
  6. history or presence of clinically relevant cardiovascular, renal, metabolic, haematological, neurological, psychiatric, systemic, infectious disease, or malignant tumour(except where there is no recurrence for more than 5 years after surgery)
  7. history of alcoholism or substance abuse
  8. participation in other clinical drug(medicine) trials during the last 30 days before study inclusion
  9. judged by the investigators to be inappropriate for the clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03310385


Locations
Korea, Republic of
Dunsan Korean Medicine Hospital, Daejeon University Not yet recruiting
Daejeon, Korea, Republic of
Contact: Yee Ran Lyu         
Sponsors and Collaborators
Daejeon University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yang Chun Park, Professor, Daejeon University
ClinicalTrials.gov Identifier: NCT03310385     History of Changes
Other Study ID Numbers: DJRM-2017-01
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yang Chun Park, Daejeon University:
Acute Bronchitis, Herbal Medicine

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