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Acute BronchitisPhase 2NCT03310385

Efficacy and Safety of GHX02 in the Treatment of Acute Bronchitis

A Phase 2 study testing GHX02 in people with Acute Bronchitis, run by Daejeon University at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 75 years
Conditions the study is for
Acute Bronchitis
What is being tested?
GHX02
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
1 siteSouth Korea
Study dates
18 Mar 2019to Mar 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • pregnant or breast-feeding
  • treatment with antibiotics, bronchodilators, glucocorticoids, immune-depressants, or other clinical trial medicines during the last 4 weeks before study inclusion
  • treatment with antitussives or expectorants during the last 7 days before study inclusion
  • 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)
  • 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)
  • 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)
Show all 9Show fewer
  • history of alcoholism or substance abuse
  • participation in other clinical drug(medicine) trials during the last 30 days before study inclusion
  • judged by the investigators to be inappropriate for the clinical trial.

Trial locations and contacts

1 site in 1 country.

YeeRan Lyu contact

82424709663

yyr900511@gmail.com

South Korea1 site

  • Dunsan Korean Medicine Hospital, Daejeon University

    Daejeon

    Yee Ran Lyu

Other trials in South Korea

About this study

Official title: Efficacy and Safety of GHX02 in the Treatment of Acute Bronchitis: a Phase 2, Double-blind, Randomized Placebo-controlled Trial

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.

Being tested
GHX02, Placebo
Keywords
Acute Bronchitis, Herbal Medicine
Medical subject headings
Bronchitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GHX02Drug

    Herbal medicine originating from gualouhengryunhwan

  • PlaceboDrug

    Placebo tablets

Study groups in NCT03310385
Study groupRoleWhat they receive
High-dose GHX02 group(1,920mg/day)Experimental4 tablets of the GHX02, three times daily for 7 days
Receives: Drug: GHX02
Standard-dose GHX02 group(960mg/day)Experimental2 tablets of the GHX02 and 2 tablets of the placebo, three times daily for 7 days
Receives: Drug: GHX02; Drug: Placebo
Placebo controlPlacebo comparator4 tablets of the placebo, three times daily for 7 days
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in BSS(Bronchitis Severity Score)

    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.

    Measured: Day0, Day7

Secondary outcomes (5)

  1. Change in Questionnaire of Clinical Symptoms of Cough and Sputum

    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.

    Measured: Day0, Day7

  2. Change in Leicester Cough Questionnaire-acute(LCQ-acute)

    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.

    Measured: Day0, Day7

  3. Change in frequency of coughing fits

    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).

    Measured: Day0, Day1, Day2, Day3, Day4, Day5, Day6, Day7

  4. Integrative Medicine Outcome Scale(IMOS)

    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).

    Measured: Day7

  5. Integrative Medicine Patient Satisfaction Scale(IMPSS)

    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)

    Measured: Day7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2017
  2. Study start18 Mar 2019 (estimated)
  3. Primary completionMar 2020 (estimated)
  4. Study completionMar 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
multicentre, dose-finding,double-blind, randomized placebo-controlled trial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03310385
Sponsor's protocol ID
DJRM-2017-01
Status last verified
Mar 2019
First submitted
6 Oct 2017
Last updated
5 Mar 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Ji KY, Kim KM, Oh JJ, Kim JW, Lee WJ, Cho H, Lee HK, Lee JY, Chae S. Assessment of the 4-week repeated-dose oral toxicity and genotoxicity of GHX02. J Appl Toxicol. 2020 Feb;40(2):270-284. doi: 10.1002/jat.3902. Epub 2019 Sep 12.

    PubMed 31515828

  • Lyu YR, Yang WK, Park SJ, Kim SH, Kang WC, Jung IC, Park YC. Efficacy and safety of GHX02 in the treatment of acute bronchitis: protocol of a phase II, double-blind, randomised placebo-controlled trial. BMJ Open. 2018 May 14;8(5):e019897. doi: 10.1136/bmjopen-2017-019897.

    PubMed 29764875

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GHX02 in people with Acute Bronchitis, run by Daejeon University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact YeeRan Lyu (82424709663, yyr900511@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in BSS(Bronchitis Severity Score) (time frame: Day0, Day7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03310385, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.

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