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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04252963
Recruitment Status : Unknown
Verified February 2020 by Hanmi Pharmaceutical Company Limited.
Recruitment status was:  Recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 2, 2018
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acute Bronchitis

Arm Intervention/treatment
Experimental: Mucolase Drug: MUCOLASE tablet (streptokinase • streptodornase)
streptokinase • streptodornase 5mg

Placebo Comparator: Placebo Drug: Placebo
Placebo of MUCOLASE tablet




Primary Outcome Measures :
  1. Change from baseline in BSS (Bronchitis Severity Score) [ Time Frame: 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 :
  1. Change from baseline in each symptom score of BSS (Bronchitis Severity Score) [ Time Frame: 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)

  2. Change from baseline in cough/sputum domain score of BSS (Bronchitis Severity Score) [ Time Frame: 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)

  3. Complete resolution rate of each symptom [ Time Frame: 7 days ]
  4. The number of use of relief drugs [ Time Frame: 7 days ]
  5. Integrative Medicine Outcomes Scale [ Time Frame: 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)

  6. Integrative Medicine Patient Satisfaction Scales [ Time Frame: 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04252963


Contacts
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Contact: Jin-A Jung, Ph.D 82-2-410-9038 jajung@hanmi.co.kr

Locations
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Korea, Republic of
Konkuk University Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Kwang-Ha Yoo, MD, Ph.D         
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
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Principal Investigator: Kwang-Ha Yoo, MD, Ph.D Konkuk University Medical Center
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Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT04252963    
Other Study ID Numbers: HM-MUC-401
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Respiratory Tract Infections
Bronchitis
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Streptokinase
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action