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

Acute Bronchitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02792946
• Other study ID #: HT-002-05
• Status: Completed
• Phase: Phase 3
• First received: June 3, 2016
• Last updated: June 15, 2017
• Start date: November 2015
• Est. completion date: January 2016

Study information

• Verified date: June 2016
• Source: Hyundai Pharmaceutical Co., LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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, ß2-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

Related Conditions & MeSH terms

• Acute Bronchitis
• Acute Disease
• Bronchitis

Intervention

Drug:
• Acebrophylline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hyundai Pharmaceutical Co., LTD.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in baseline to Day 7 for total number of Bronchitis Severity Score (BSS)		Baseline, At Day 7
Secondary	Change from Baseline in baseline to Day 7 for number of BSS per symptom		Baseline, At Day 7
Secondary	Response rate at Day 7		Baseline, At Day 7