Acute Bronchitis
Conditions
Brief summary
Compare the efficacy and safety of surfolase CR tablet with surfolate capsule in patients with acute bronchitis
Interventions
DRUGAcebrophylline
Sponsors
Hyundai Pharmaceutical Co., LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in baseline to Day 7 for total number of Bronchitis Severity Score (BSS) | Baseline, At Day 7 |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in baseline to Day 7 for number of BSS per symptom | Baseline, At Day 7 |
| Response rate at Day 7 | Baseline, At Day 7 |
Outcome results
None listed