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Completed

NCT Number: NCT02637310

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

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Key information

Conditions

Acute Bronchitis Bronchial Diseases Bronchitis Infections Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

N02RS1 1200mg

Drug

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

Placebo

Drug

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

Primary outcomes

  1. BSS(Bronchitis Severity Score) score variation compared to baseline after 7 days

    Time frame: Visit 1(-3days, screening), 2(0day, randomization), 3(3days), 4(8days)

Sponsors and collaborators

Lead sponsor

PharmaKing

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 22, 2015
Registry last updated
Mar 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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