Acute Bronchitis, Acute Upper Respiratory Infection
Conditions
Brief summary
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
Interventions
DRUGMUCOLASE tablet (streptokinase • streptodornase)
streptokinase • streptodornase 5mg
DRUGPlacebo
Placebo of MUCOLASE tablet
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in BSS (Bronchitis Severity Score) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in cough/sputum domain score of BSS (Bronchitis Severity Score) | 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) |
| Complete resolution rate of each symptom | 7 days | — |
| Change from baseline in each symptom score of BSS (Bronchitis Severity Score) | 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) |
| Integrative Medicine Outcomes Scale | 7 days | 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) |
| Integrative Medicine Patient Satisfaction Scales | 7 days | 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) |
| The number of use of relief drugs | 7 days | — |
Countries
South Korea
Contacts
Primary ContactJin-A Jung, Ph.D
Outcome results
None listed