NCT02637310

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2015

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 22, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 30, 2016

Status Verified

March 1, 2016

Enrollment Period

3 months

First QC Date

December 8, 2015

Last Update Submit

March 29, 2016

Conditions

Acute Bronchitis

Outcome Measures

Primary Outcomes (1)

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

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

Study Arms (2)

N02RS1 1200mg

EXPERIMENTAL

Combination of Broussonetia spp and Lonicera spp

Drug: N02RS1 1200mg

Placebo

PLACEBO COMPARATOR

sugar pill

Drug: Placebo

Interventions

N02RS1 1200mgDRUG

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

N02RS1 1200mg
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bronchitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2015

First Posted

December 22, 2015

Study Start

December 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 30, 2016

Record last verified: 2016-03