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

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ClinicalTrials.gov Identifier: NCT02792946
Recruitment Status : Completed
First Posted : June 8, 2016
Last Update Posted : June 16, 2017
Information provided by (Responsible Party):
Hyundai Pharmaceutical Co., LTD.

Brief Summary:
Compare the efficacy and safety of surfolase CR tablet with surfolate capsule in patients with acute bronchitis

Condition or disease Intervention/treatment Phase
Acute Bronchitis Drug: Acebrophylline Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Actual Study Start Date : November 2015
Primary Completion Date : January 2016
Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acute Bronchitis
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Change from Baseline in baseline to Day 7 for number of BSS per symptom [ Time Frame: Baseline, At Day 7 ]
  2. Response rate at Day 7 [ Time Frame: Baseline, At Day 7 ]

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

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

Responsible Party: Hyundai Pharmaceutical Co., LTD.
ClinicalTrials.gov Identifier: NCT02792946     History of Changes
Other Study ID Numbers: HT-002-05
First Posted: June 8, 2016    Key Record Dates
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:
Acute Disease
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes