NCT01979926

Brief Summary

The Purpose of A Multicenter, Randomized, Double-blind, Placebo-controlled to Evaluate the Efficacy, Safety and Pharmacokinetics of N02RS1 600mg and 1,200mg per day in Patients With acute and acute exacerbation of chronic bronchitis for 7 days.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

October 31, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

May 30, 2014

Status Verified

May 1, 2014

Enrollment Period

Same day

First QC Date

October 31, 2013

Last Update Submit

May 29, 2014

Conditions

Acute Exacerbation of Chronic Bronchitis

Outcome Measures

Primary Outcomes (1)

  • Safety

    1.Adverse Event: symptom, start day and time, end day and time, injection time, severity, progress, outcome, relation with investigational product.

    12weeks

Secondary Outcomes (1)

  • Efficacy

    12weeks

Study Arms (3)

N02RS1 200mg

EXPERIMENTAL

Combination of Broussonetia spp and Lonicera spp

Drug: Combination of Broussonetia spp and Lonicera spp

N02RS1 400mg

EXPERIMENTAL

Combination of Broussonetia spp and Lonicera spp

Drug: Combination of Broussonetia spp and Lonicera spp

Placebo

PLACEBO COMPARATOR

Sugar pill

Drug: Combination of Broussonetia spp and Lonicera spp

Interventions

Combination of Broussonetia spp and Lonicera sppDRUG

600 mg/ day or 1200 mg/ day for 7 days

Also known as: N02RS1
N02RS1 200mgN02RS1 400mgPlacebo

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over 18, under 75 years of age
  • Patients Acute and Chronic Bronchitis

You may not qualify if:

  • Patients who have gotten a glucocorticoids treatment within 4 weeks.
  • Patients who need treatments of antibiotic and acute bronchitis infection.
  • Patients who have gotten teatments of antibiotic,bronchodilator,painkiller and secretagog within 7 days.
  • Bronchial asthma patient.
  • Patients who have an indication of bleeding.
  • Patients who have a serious heart and renal disease or liver ailment or immunosuppressive response.
  • Patients who have history of over 3 phage of Chronic obstructiv lung disease
  • Bronchiectasis patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul Nat'l University of Boramae Hospital

Seoul, Seoul, South Korea

Location

Study Officials

  • Wayne B An, Bs

    Korea Pharmaceutical Manufacturers Association

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 31, 2013

First Posted

November 8, 2013

Study Start

November 1, 2013

Primary Completion

November 1, 2013

Study Completion

March 1, 2014

Last Updated

May 30, 2014

Record last verified: 2014-05

Locations

KR(1)