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

Phase 3

Completed

• Conditions: Acute Bronchitis
• Interventions: Drug: Acebrophylline

• Registration Number: NCT02792946
• Lead Sponsor: Hyundai Pharmaceutical Co., LTD.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-06
• Study First Submitted: 2016-06-03
• Study First Submitted QC: 2016-06-03
• Study First Posted: 2016-06-08
• Last Update Submitted: 2017-06-15
• Last Update Posted: 2017-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 244

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sulfolase CR (200mg, QD)	Acebrophylline	for 7 days with or without meal
Sulfolase Capsule (100mg, BID)	Acebrophylline	for 7 days with or without meal

Primary Outcome Measures

Name	Time	Method
Change from Baseline in baseline to Day 7 for total number of Bronchitis Severity Score (BSS)	Baseline, At Day 7

Secondary Outcome Measures

Name	Time	Method
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