Clinical Trial to Assess the Efficacy and Safety of MUCOLASE Tablet(Streptokinase • Streptodornase)

Acute Bronchitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04252963
• Other study ID #: HM-MUC-401
• Status: Recruiting
• Phase: Phase 4
• Start date: November 2, 2018
• Est. completion date: May 2021

Study information

• Verified date: February 2020
• Source: Hanmi Pharmaceutical Company Limited
• Contact: Jin-A Jung, Ph.D
• Phone: 82-2-410-9038
• Email: jajung[@]hanmi.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A phase 4 study to evaluate efficacy and safety of MUCOLASE tablet (streptokinase • streptodornase)

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 346
• Est. completion date: May 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Bronchitis
• Acute Upper Respiratory Infection
• Bronchitis
• Infection
• Respiratory Tract Infections

Intervention

Drug:
• MUCOLASE tablet (streptokinase • streptodornase)
streptokinase • streptodornase 5mg
• Placebo
Placebo of MUCOLASE tablet

Locations

Country	Name	City	State
Korea, Republic of	Konkuk University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	baseline, 7 days
Secondary	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)	baseline, 7 days
Secondary	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)	baseline, 7 days
Secondary	Complete resolution rate of each symptom		7 days
Secondary	The number of use of relief drugs		7 days
Secondary	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)	7 days
Secondary	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)	7 days