NCT03654196

Brief Summary

A Multicenter, Randomized, Double-blinded, Active-controlled, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of HL301 versus Umkamin tab. in acute bronchitis patients Endpoint: BSS, The improvement and improvement rate of the tester for the treatment response, The satisfaction of the subject

Trial Health

87
On Track

Trial Health Score

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

Enrollment
246

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2018

Shorter than P25 for phase_3

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

Study Start

First participant enrolled

March 16, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2018

Completed
Last Updated

February 12, 2019

Status Verified

February 1, 2019

Enrollment Period

6 months

First QC Date

August 29, 2018

Last Update Submit

February 10, 2019

Conditions

Acute Bronchitis

Keywords

Acute Bronchitis

Outcome Measures

Primary Outcomes (1)

  • Bronchitis Severity Total Score(BSS) Change

    The BSS comprises the following five symptoms typical for Acute Bronchitis: cough, sputum, rales on auscultation, chest pain on coughing, and dyspnoea. These symptoms are each assessed according to a 5-point Likert scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe

    Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day)

Secondary Outcomes (2)

  • The improvement and improvement rate of the tester for the treatment

    Visit 3 (7 day)

  • The satisfaction of the subject (Questionnaire)

    Visit 3 (7 day)

Study Arms (2)

HL301(Experimental)

EXPERIMENTAL

Total 7 days of treatment and The daily dose is as follows \[Morning: HL301 1Tab + Placebo of Umkamin 1Tab\] \[Noon: Placebo of Umkamin 1Tab\] \[Evening: HL301 1Tab + Placebo of Umkamin 1Tab\]

Drug: HL301(Experimental)

Umkamin(Active Comparator)

ACTIVE COMPARATOR

Total 7 days of treatment and The daily dose is as follows \[Morning: Placebo of HL301 1Tab + Umkamin 1Tab\] \[Noon: Umkamin 1Tab\] \[Evening: Placebo of HL301 1Tab + Umkamin 1Tab\]

Drug: Umkamin(Active Comparator)

Interventions

HL301(Experimental)DRUG

Total 7 days of treatment and The daily dose is as follows \[Morning: HL301 1Tab + Placebo of Umkamin 1Tab\] \[Noon: Placebo of Umkamin 1Tab\] \[Evening: HL301 1Tab + Placebo of Umkamin 1Tab\]

Also known as: HL301 and Placebo of Umkamin
HL301(Experimental)
Umkamin(Active Comparator)DRUG

Total 7 days of treatment and The daily dose is as follows \[Morning: Placebo of HL301 1Tab + Umkamin 1Tab\] \[Noon: Umkamin 1Tab\] \[Evening: Placebo of HL301 1Tab + Umkamin 1Tab\]

Also known as: Placebo of HL301 and Umkamin
Umkamin(Active Comparator)

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both gender, 19 years ≤ age ≤ 80 years
  • (Bronchitis Severity Score)\* ≥ 5point at Visit 2 (Randomized Visit)
  • Acute bronchitis within 48hr based on Visit 2 (Randomized Visit)
  • Those who can comply with the requirements of clinical trials
  • Written consent voluntarily to participate in this clinical trial

You may not qualify if:

  • Patients with respiratory and systemic infections requiring systemic antibiotic therapy
  • Patients with bleeding tendency
  • Patients who investigators determines to severe respiratory disease that would interfere with study assessment
  • Patients who were treated with oral systemic adrenocortical hormone or immunosuppressive drug within 4 weeks prior to Visit 2
  • Patients who were treated with oral antihistamines, ACE suppressive. or systemic/inhalative glucocorticosteroid within 2 weeks prior to Visit 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyung Hee University Hospital

Seoul, Dongdaemun-gu, 130-872, South Korea

Location

MeSH Terms

Conditions

Bronchitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2018

First Posted

August 31, 2018

Study Start

March 16, 2018

Primary Completion

September 21, 2018

Study Completion

September 21, 2018

Last Updated

February 12, 2019

Record last verified: 2019-02

Locations

KR(1)