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

Sponsor

Hanmi Pharmaceutical Company Limited (Industry)

Overall Status

Unknown status

CT.gov ID

NCT04252963

Collaborator

(none)

346

Enrollment

Location

Arms

29.9

Anticipated Duration (Months)

11.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acute Upper Respiratory Infection Acute Bronchitis	Drug: MUCOLASE tablet (streptokinase • streptodornase) Drug: Placebo	Phase 4

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

Study Type:

Interventional

Anticipated Enrollment :

346 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 2, 2018

Anticipated Primary Completion Date :

Feb 1, 2021

Anticipated Study Completion Date :

May 1, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Mucolase

Drug: MUCOLASE tablet (streptokinase • streptodornase)

streptokinase • streptodornase 5mg

Placebo Comparator: Placebo

Drug: Placebo

Placebo of MUCOLASE tablet

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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)
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]
The number of use of relief drugs [7 days]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Konkuk University Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

Hanmi Pharmaceutical Company Limited

Investigators

Principal Investigator: Kwang-Ha Yoo, MD, Ph.D, Konkuk University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hanmi Pharmaceutical Company Limited

ClinicalTrials.gov Identifier:

NCT04252963

Other Study ID Numbers:

HM-MUC-401

First Posted:

Feb 5, 2020

Last Update Posted:

Feb 5, 2020

Last Verified:

Feb 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infections

Respiratory Tract Infections

Bronchitis

Streptokinase

Study Results

No Results Posted as of Feb 5, 2020