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
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Notify MeKey information
Conditions
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
Primary outcomes
-
Change from Baseline in baseline to Day 7 for total number of Bronchitis Severity Score (BSS)
Time frame: Baseline, At Day 7
Secondary outcomes
-
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
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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