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Compare the Efficacy and Safety of Surfolase CR Tablet With Surfolase Capsule in Patients With Acute Bronchitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02792946
First Posted: June 8, 2016
Last Update Posted: June 16, 2017
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.
Information provided by (Responsible Party):
Hyundai Pharmaceutical Co., LTD.
  Purpose
Compare the efficacy and safety of surfolase CR tablet with surfolate capsule in patients with acute bronchitis

Condition Intervention Phase
Acute Bronchitis Drug: Acebrophylline Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hyundai Pharmaceutical Co., LTD.:

Primary Outcome Measures:
  • Change from Baseline in baseline to Day 7 for total number of Bronchitis Severity Score (BSS) [ Time Frame: Baseline, At Day 7 ]

Secondary Outcome Measures:
  • Change from Baseline in baseline to Day 7 for number of BSS per symptom [ Time Frame: Baseline, At Day 7 ]
  • Response rate at Day 7 [ Time Frame: Baseline, At Day 7 ]

Enrollment: 244
Actual Study Start Date: November 2015
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sulfolase CR (200mg, QD)
for 7 days with or without meal
Drug: Acebrophylline
Active Comparator: Sulfolase Capsule (100mg, BID)
for 7 days with or without meal
Drug: Acebrophylline

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female aged 19 to 65 years, inclusive
  2. Patients with acute bronchitis which is accompanied with a cough which includes sputum within 48 hours and has over 5 for Bronchitis severity score (BSS) at Screening
  3. Patients who agreed to participate clinical trial and sign on informed consent form

Exclusion Criteria:

  1. Patients who are suspicious or diagnosed for pneumonia
  2. Patients with chronic bronchitis, Chronic Obstructive Pulmonary Disease (COPD), bronchiolitis, asthma, bronchial asthma
  3. Patients with active infection who needs administration of antibiotics
  4. Patients with myocardial infarction, congestive heart failure
  5. Patients with renal disorder or liver disorder
  6. Patients with hypotension or hypertension
  7. Patients with history of epilepsy
  8. Patients with hyperthyroidism
  9. Patients with gastroduodenal ulcer
  10. Patients with sever hypoxemia
  11. Patients who are in drug or therapy or planned to have;

    • antibiotics, anti-virus, angiotensin converting enzyme (ACE) inhibitor and systemic or inhalation glucocorticosteroids: from 2 weeks prior to administration of investigational product to termination of clinical trial
    • Angiotension II receptor blocker (ARB), secretolytics/mucolytics, expectorants, antitussives, a herb medicines which has antitussive or expectorant effect: from 2 days prior to administration of investigational product to termination of clinical trial
    • Analgesics except acetaminophen, antihistamines, β2-agonists, bronchodilators which includes anticholinergic agents, xanthine derivatives, central nervous system stimulants, drug which is known for interaction between acebrophylline (cimetidine, alloprinol, oral anticoagulants, furosemide, reserpine, barbiturates, phenytoin) and symtomatic therapy for other therapy for acute bronchitis: whole period for clinical trial
  12. Smokers
  13. Patients who has history for drug hypersensitivity or allergic reaction in component of investigational product or similar drug
  14. Patients with pregnant and/or have breast feeding.
  15. Patients with no intention to use appropriate contraceptives or has a plan to become pregnant
  16. Patients who had an administrationb of other investigational product or medical device for clinical trial 4 weeks prior to participation of clinical trial
  17. Patients who are identified as inappropriate by other investigators to participate clinical trial
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Hyundai Pharmaceutical Co., LTD.
ClinicalTrials.gov Identifier: NCT02792946     History of Changes
Other Study ID Numbers: HT-002-05
First Submitted: June 3, 2016
First Posted: June 8, 2016
Last Update Posted: June 16, 2017
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Bronchitis
Acute Disease
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes