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

NCT04252963 | Unknown Phase 4

• 1 other identifier: HM-MUC-401
• Study Type: interventional
• Target: 346
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Upper Respiratory Infection; Acute Bronchitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change from baseline in each symptom score of BSS (Bronchitis Severity Score)

  baseline, 7 days

• Change from baseline in cough/sputum domain score of BSS (Bronchitis Severity Score)

  baseline, 7 days

• Complete resolution rate of each symptom

  7 days

• The number of use of relief drugs

  7 days

• Integrative Medicine Outcomes Scale

  7 days

Study Arms (2)

Mucolase

EXPERIMENTAL

Drug: MUCOLASE tablet (streptokinase • streptodornase)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

MUCOLASE tablet (streptokinase • streptodornase) DRUG

streptokinase • streptodornase 5mg

Mucolase

Placebo DRUG

Placebo of MUCOLASE tablet

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Konkuk University Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Bronchitis

Interventions

Streptodornase and Streptokinase

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Deoxyribonuclease I; Endodeoxyribonucleases; Deoxyribonucleases; Esterases; Hydrolases; Enzymes; Enzymes and Coenzymes; Streptokinase; Endopeptidases; Peptide Hydrolases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Kwang-Ha Yoo, MD, Ph.D

  Konkuk University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin-A Jung, Ph.D

CONTACT

82-2-410-9038; jajung@hanmi.co.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 5, 2020
• Study Start: November 2, 2018
• Primary Completion: February 1, 2021
• Study Completion: May 1, 2021
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

KR (1)