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

NCT ID: NCT02792946

Last Updated: 2017-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 244 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2016-01-31

Brief Summary

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

Conditions

Acute Bronchitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Sulfolase CR (200mg, QD)

for 7 days with or without meal

Group Type: EXPERIMENTAL

Acebrophylline

Intervention Type: DRUG

Sulfolase Capsule (100mg, BID)

for 7 days with or without meal

Group Type: ACTIVE_COMPARATOR

Acebrophylline

Intervention Type: DRUG

Interventions

Acebrophylline

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hyundai Pharmaceutical Co., LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

HT-002-05

Identifier Type: -

Identifier Source: org_study_id