Evaluate the Efficacy and Safety of N02RS1 in Patient With Acute Bronchitis

A Multi Center, Randomized, Double-blind, Placebo-controlled, Parallel, Phase 2b Clinical Trial to Evaluate the Efficacy and Safety of N02RS1 in Patients With Acute Bronchitis

A multi center, randomized, double-blind, placebo-controlled, parallel, phase 2b clinical trial to evaluate the efficacy and safety of N02RS1 in patients with acute bronchitis

Study Overview

• Status: Completed
• Conditions: Acute Bronchitis
• Intervention / Treatment: Drug: N02RS1 1200mg; Drug: Placebo

Detailed Description

Suitable subjects randomized to the experimental or control group. The subjects eat IP during 7days. Visit 3(3 days) evaluate BSS through phone call and visit 4(8 days) evaluate efficacy and safety.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients over 19, under 75 of age
• Patients acute bronchitis, sputum symptoms, BSS over 7 points.
• Patients acute bronchitis within 7days.
• Non-pregnant, patients who agree to contraception.
• Patients who can write diary and available to communicate.
• Patients voluntarily agreed

Exclusion Criteria:

• Patients with hypersensitivity to the drug.
• Patients who have gotten systemic steroid treatment within 4 weeks.
• Patients who have gotten treatment of antibiotics, bronchodilators, painkiller and secretagog within 7 days.
• Patients who have gotten treatment of mucus solvents or antitussives within 3 days.
• Patients who serious respiratory infections requiring antibiotic treatment, allergic bronchial asthma, bronchiectasis and chronic obstructive pulmonary disease.
• Patients heart disease, severe kidney, liver disease.
• The bleeding tendency or immunosuppressed patients.
• Patients with clinically significant abnormal values.
• Pregnant women or nursing mothers.
• Patients alcoholics or drug abuse.
• Patients taking other clinical trail's medicines within 30 days.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; sugar pill	Drug: Placebo; 1200mg/day, Three times a day orally, 2 tablets once, 7 days
Experimental: N02RS1 1200mg; Combination of Broussonetia spp and Lonicera spp	Drug: N02RS1 1200mg; 1200mg/day, Three times a day orally, 2 tablets once, 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
BSS(Bronchitis Severity Score) score variation compared to baseline after 7 days	Visit 1(-3days, screening), 2(0day, randomization), 3(3days), 4(8days)

Collaborators and Investigators

• Sponsor: PharmaKing

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: December 8, 2015
• First Submitted That Met QC Criteria: December 17, 2015
• First Posted (Estimate): December 22, 2015

Study Record Updates

• Last Update Posted (Estimate): March 30, 2016
• Last Update Submitted That Met QC Criteria: March 29, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Bronchial Diseases; Lung Diseases, Obstructive; Acute Disease; Bronchitis
• Other Study ID Numbers: PMK-N02RS1_Phase 2B