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

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)

Study Overview

• Status: Unknown
• Conditions: Acute Upper Respiratory Infection; Acute Bronchitis
• Intervention / Treatment: Drug: MUCOLASE tablet (streptokinase • streptodornase); Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 346
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jin-A Jung, Ph.D; Phone Number: 82-2-410-9038; Email: jajung@hanmi.co.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Konkuk University Medical Center
    • Contact: Kwang-Ha Yoo, MD, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo of MUCOLASE tablet
Experimental: Mucolase	Drug: MUCOLASE tablet (streptokinase • streptodornase); streptokinase • streptodornase 5mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Complete resolution rate of each symptom		7 days
The number of use of relief drugs		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)	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)	7 days

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited
• Investigators: Principal Investigator: Kwang-Ha Yoo, MD, Ph.D, Konkuk University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2018
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: January 31, 2020
• First Submitted That Met QC Criteria: January 31, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 3, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Infections; Respiratory Tract Infections; Bronchitis; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Streptokinase
• Other Study ID Numbers: HM-MUC-401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No