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OpenTrials
Completed

NCT Number: NCT02792946

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

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

Completed

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Key information

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female aged 19 to 65 years, inclusive
  • 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
  • Patients who agreed to participate clinical trial and sign on informed consent form

Exclusion criteria

  • Patients who are suspicious or diagnosed for pneumonia
  • Patients with chronic bronchitis, Chronic Obstructive Pulmonary Disease (COPD), bronchiolitis, asthma, bronchial asthma
  • Patients with active infection who needs administration of antibiotics
  • Patients with myocardial infarction, congestive heart failure
  • Patients with renal disorder or liver disorder
  • Patients with hypotension or hypertension
  • Patients with history of epilepsy
  • Patients with hyperthyroidism
  • Patients with gastroduodenal ulcer
  • Patients with sever hypoxemia
  • 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
  • Smokers
  • Patients who has history for drug hypersensitivity or allergic reaction in component of investigational product or similar drug
  • Patients with pregnant and/or have breast feeding.
  • Patients with no intention to use appropriate contraceptives or has a plan to become pregnant
  • Patients who had an administrationb of other investigational product or medical device for clinical trial 4 weeks prior to participation of clinical trial
  • Patients who are identified as inappropriate by other investigators to participate clinical trial

Treatment and study plan

Acebrophylline

Drug

Primary outcomes

  1. Change from Baseline in baseline to Day 7 for total number of Bronchitis Severity Score (BSS)

    Time frame: Baseline, At Day 7

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hyundai Pharmaceutical Co., LTD.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 8, 2016
Registry last updated
Jun 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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