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

NCT02792946 | Completed Phase 3

• 1 other identifier: HT-002-05
• Study Type: interventional
• Target: 244
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Acute Bronchitis

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in baseline to Day 7 for total number of Bronchitis Severity Score (BSS)

  Baseline, At Day 7

Secondary Outcomes (2)

• 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

Study Arms (2)

Sulfolase CR (200mg, QD)

EXPERIMENTAL

for 7 days with or without meal

Drug: Acebrophylline

Sulfolase Capsule (100mg, BID)

ACTIVE COMPARATOR

for 7 days with or without meal

Drug: Acebrophylline

Interventions

Acebrophylline DRUG

Sulfolase CR (200mg, QD); Sulfolase Capsule (100mg, BID)

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 19 to 65 years, inclusive
• 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
• Patients who agreed to participate clinical trial and sign on informed consent form

You may not qualify if:

• Patients who are suspicious or diagnosed for pneumonia
• Patients with chronic bronchitis, Chronic Obstructive Pulmonary Disease (COPD), bronchiolitis, asthma, bronchial asthma
• Patients with active infection who needs administration of antibiotics
• Patients with myocardial infarction, congestive heart failure
• Patients with renal disorder or liver disorder
• Patients with hypotension or hypertension
• Patients with history of epilepsy
• Patients with hyperthyroidism
• Patients with gastroduodenal ulcer
• Patients with sever hypoxemia
• 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
• Smokers

Sponsors & Collaborators

• Hyundai Pharmaceutical Co., LTD.: lead

MeSH Terms

Conditions

Bronchitis

Interventions

ambroxol-theophylline-7-acetate

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2016
• First Posted: June 8, 2016
• Study Start: November 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: June 16, 2017

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share