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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02637310

Enrollment

108

Registered

2015-12-22

Start date

2015-12-31

Completion date

2016-03-31

Last updated

2016-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Bronchitis

Brief summary

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

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.

Interventions

DRUGN02RS1 1200mg

1200mg/day, Three times a day orally, 2 tablets once, 7 days

DRUGPlacebo

1200mg/day, Three times a day orally, 2 tablets once, 7 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026