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

Primary Purpose

Acute Upper Respiratory Infection, Acute Bronchitis

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
MUCOLASE tablet (streptokinase • streptodornase)
Placebo
Sponsored by
Hanmi Pharmaceutical Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Upper Respiratory Infection

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Konkuk University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mucolase

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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)
Complete resolution rate of each symptom
The number of use of relief drugs
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)
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)

Full Information

First Posted
January 31, 2020
Last Updated
February 3, 2020
Sponsor
Hanmi Pharmaceutical Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT04252963
Brief Title
Clinical Trial to Assess the Efficacy and Safety of MUCOLASE Tablet(Streptokinase • Streptodornase)
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 2, 2018 (Actual)
Primary Completion Date
February 2021 (Anticipated)
Study Completion Date
May 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Upper Respiratory Infection, Acute Bronchitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
346 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mucolase
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
MUCOLASE tablet (streptokinase • streptodornase)
Intervention Description
streptokinase • streptodornase 5mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo of MUCOLASE tablet
Primary Outcome Measure Information:
Title
Change from baseline in BSS (Bronchitis Severity Score)
Description
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)
Time Frame
baseline, 7 days
Secondary Outcome Measure Information:
Title
Change from baseline in each symptom score of BSS (Bronchitis Severity Score)
Description
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)
Time Frame
baseline, 7 days
Title
Change from baseline in cough/sputum domain score of BSS (Bronchitis Severity Score)
Description
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)
Time Frame
baseline, 7 days
Title
Complete resolution rate of each symptom
Time Frame
7 days
Title
The number of use of relief drugs
Time Frame
7 days
Title
Integrative Medicine Outcomes Scale
Description
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)
Time Frame
7 days
Title
Integrative Medicine Patient Satisfaction Scales
Description
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)
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin-A Jung, Ph.D
Phone
82-2-410-9038
Email
jajung@hanmi.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwang-Ha Yoo, MD, Ph.D
Organizational Affiliation
Konkuk University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Konkuk University Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kwang-Ha Yoo, MD, Ph.D

12. IPD Sharing Statement

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

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