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

Study Overview

• Status: Completed
• Conditions: Acute Bronchitis
• Intervention / Treatment: Drug: Acebrophylline

• Study Type: Interventional
• Enrollment (Actual): 244
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sulfolase CR (200mg, QD); for 7 days with or without meal	Drug: Acebrophylline
Active Comparator: Sulfolase Capsule (100mg, BID); for 7 days with or without meal	Drug: Acebrophylline

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Hyundai Pharmaceutical Co., LTD.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: June 3, 2016
• First Submitted That Met QC Criteria: June 3, 2016
• First Posted (Estimate): June 8, 2016

Study Record Updates

• Last Update Posted (Actual): June 16, 2017
• Last Update Submitted That Met QC Criteria: June 15, 2017
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Respiratory System Agents; Expectorants; Ambroxol
• Other Study ID Numbers: HT-002-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No