Acute Upper Respiratory InfectionPhase 4NCT04252963
Clinical Trial to Assess the Efficacy and Safety of MUCOLASE Tablet(Streptokinase • Streptodornase)
A Phase 4 study testing MUCOLASE tablet (streptokinase • streptodornase) in people with Acute Upper Respiratory Infection and Acute Bronchitis, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
A phase 4 study to evaluate efficacy and safety of MUCOLASE tablet (streptokinase • streptodornase) Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Upper Respiratory Infection, Acute Bronchitis
- What is being tested?
- MUCOLASE tablet (streptokinase • streptodornase)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 346 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Nov 2018to May 2021
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19≤ age
- Patients with acute upper respiratory infection or acute bronchitis
- Patients with cough and phlegm within 48 hrs as of Visit 1
- Patients understood the consents and purpose of this trial and signed consent form
Who cannot join
- Patients with high fever (≥39℃)
- Patients with severe respiratory diseases (ex) bronchial asthma, pneumonia, pulmonary tuberculosis, bronchiectasis, mucus sticking, chronic obstructive pulmonary disease (COPD), etc.
- Patients with a history of hypersensitivity to drug
- Patients with abnormal blood coagulation
- Patients with thrombocytopenia
- Patients with uncontrolled hypertension
- Patients with a severe liver disorder(AST or ALT level exceeds 2 times more than normal upper range)
- Patients woth a clinically significant renal failure(MDRD eGFP < 60 mL/min/1.73m2)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Konkuk University Medical Center
Seoul
Kwang-Ha Yoo, MD, Ph.D
About this study
Official title: Double-blind, Randomized, Placebo Controlled, Multicenter, Phase IV Clinical Trial to Assess the Efficacy and Safety of MUCOLASE Tablet (Streptokinase • Streptodornase) in Patients With Acute Upper Respiratory Infection or Acute Bronchitis
A phase 4 study to evaluate efficacy and safety of MUCOLASE tablet (streptokinase • streptodornase)
Read the detailed description
Double-blind, randomized, placebo controlled, multicenter, phase 4 clinical trial to assess the efficacy and safety of MUCOLASE tablet (streptokinase • streptodornase) in patients with acute upper respiratory infection or acute bronchitis
- Being tested
- MUCOLASE tablet (streptokinase • streptodornase), Placebo
- Medical subject headings
- Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MUCOLASE tablet (streptokinase • streptodornase)Drug
streptokinase • streptodornase 5mg
PlaceboDrug
Placebo of MUCOLASE tablet
| Study group | Role | What they receive |
|---|---|---|
| Mucolase | Experimental | Not described Receives: Drug: MUCOLASE tablet (streptokinase • streptodornase) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in BSS (Bronchitis Severity Score)
BSS (Bronchitis Severity Score) is derived by summing responses to five major symptoms (i. e. cough, sputum, rales/rhonchi, chest pain during coughing, dyspnoea) with higher scores indicating more severe symptomatology, rated from 0 to 4 (0 = absent, 1 = mild, 2=moderate, 3 = severe, 4 = very severe)
Measured: baseline, 7 days
Secondary outcomes (6)
Change from baseline in each symptom score of BSS (Bronchitis Severity Score)
BSS (Bronchitis Severity Score) is derived by summing responses to five major symptoms (i. e. cough, sputum, rales/rhonchi, chest pain during coughing, dyspnoea) with higher scores indicating more severe symptomatology, rated from 0 to 4 (0 = absent, 1 = mild, 2=moderate, 3 = severe, 4 = very severe)
Measured: baseline, 7 days
Change from baseline in cough/sputum domain score of BSS (Bronchitis Severity Score)
BSS (Bronchitis Severity Score) is derived by summing responses to five major symptoms (i. e. cough, sputum, rales/rhonchi, chest pain during coughing, dyspnoea) with higher scores indicating more severe symptomatology, rated from 0 to 4 (0 = absent, 1 = mild, 2=moderate, 3 = severe, 4 = very severe)
Measured: baseline, 7 days
Complete resolution rate of each symptom
Measured: 7 days
The number of use of relief drugs
Measured: 7 days
Integrative Medicine Outcomes Scale
Integrative Medicine Outcomes Scale is assessed separately by th subjects and thd investigators at end of study, based on BSS of baseline. (Scoring system: 1 = complete recovery, 2 = major improvement, 3 = slight-to-moderate improvement, 4 = no change, 5 =deterioration)
Measured: 7 days
Integrative Medicine Patient Satisfaction Scales
Integrative Medicine Outcomes Scale is assessed by subgects at end of study. (Scoring system: 1 = very satisfied, 2 = satisfied, 3 = neutral, 4 = dissatisfied, 5 =very dissatisfied)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start2 Nov 2018
- Primary completionFeb 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Upper Respiratory InfectionStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 346 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kwang-Ha Yoo, MD, Ph.D, Principal investigator, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252963
- Sponsor's protocol ID
- HM-MUC-401
- Status last verified
- Feb 2020
- First submitted
- 31 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Placebo Controlled, Multicenter, Phase IV Clinical Trial to Assess the Efficacy and Safety of MUCOLASE Tablet (Streptokinase • Streptodornase) in Patients With Acute Upper Respiratory Infection or Acute Bronchitis
- ClinicalTrials.gov ID
- NCT04252963
- Acronym / sponsor ID
- HM-MUC-401
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 346 participants (estimated)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2018 (actual)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase 4 study to evaluate efficacy and safety of MUCOLASE tablet (streptokinase • streptodornase)
Detailed description
Double-blind, randomized, placebo controlled, multicenter, phase 4 clinical trial to assess the efficacy and safety of MUCOLASE tablet (streptokinase • streptodornase) in patients with acute upper respiratory infection or acute bronchitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mucolase | Experimental | Drug: MUCOLASE tablet (streptokinase • streptodornase) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 19≤ age
- Patients with acute upper respiratory infection or acute bronchitis
- Patients with cough and phlegm within 48 hrs as of Visit 1
- Patients understood the consents and purpose of this trial and signed consent form
Key exclusion criteria (8 listed)
- Patients with high fever (≥39℃)
- Patients with severe respiratory diseases (ex) bronchial asthma, pneumonia, pulmonary tuberculosis, bronchiectasis, mucus sticking, chronic obstructive pulmonary disease (COPD), etc.
- Patients with a history of hypersensitivity to drug
- Patients with abnormal blood coagulation
- Patients with thrombocytopenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MUCOLASE tablet (streptokinase • streptodornase)streptokinase • streptodornase 5mg | Drug | Mucolase |
| PlaceboPlacebo of MUCOLASE tablet | Drug | Placebo |
Primary outcome
Change from baseline in BSS (Bronchitis Severity Score)
Time frame: baseline, 7 days
BSS (Bronchitis Severity Score) is derived by summing responses to five major symptoms (i. e. cough, sputum, rales/rhonchi, chest pain during coughing, dyspnoea) with higher scores indicating more severe symptomatology, rated from 0 to 4 (0 = absent, 1 = mild, 2=moderate, 3 = severe, 4 = very severe)
6 secondary outcomes
Change from baseline in each symptom score of BSS (Bronchitis Severity Score)
Time frame: baseline, 7 days
Change from baseline in cough/sputum domain score of BSS (Bronchitis Severity Score)
Time frame: baseline, 7 days
Complete resolution rate of each symptom
Time frame: 7 days
The number of use of relief drugs
Time frame: 7 days
Integrative Medicine Outcomes Scale
Time frame: 7 days
Integrative Medicine Patient Satisfaction Scales
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kwang-Ha Yoo, MD, Ph.D principal investigator
Konkuk University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MUCOLASE tablet (streptokinase • streptodornase) in people with Acute Upper Respiratory Infection and Acute Bronchitis, run by Hanmi Pharmaceutical Company Limited 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 8 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 Feb 2020. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Jin-A Jung, Ph.D (82-2-410-9038, jajung@hanmi.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in BSS (Bronchitis Severity Score) (time frame: baseline, 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2020.