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

Hyundai Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Acute Bronchitis

Treatments: Drug: Acebrophylline

Study type: Interventional

Funder types: Industry

Identifiers

NCT02792946

HT-002-05

Details and patient eligibility

About

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

Enrollment: 244 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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244 participants in 2 patient groups

Sulfolase CR (200mg, QD)

Experimental group

Description:

for 7 days with or without meal

Treatment:

Drug: Acebrophylline

Sulfolase Capsule (100mg, BID)

Active Comparator group

Description:

for 7 days with or without meal

Treatment:

Drug: Acebrophylline