A Clinical Trial to Evaluate the Efficacy and Safety of HL301 Versus Placebo in Acute Bronchitis Patients

NCT03309800 | Completed Phase 2

• 1 other identifier: HL_HL301_202
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Bronchitis

Keywords

Acute Bronchitis

Outcome Measures

Primary Outcomes (1)

• Bronchitis Severity Total Score(BSS) Change

  Evaluation period: Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day)

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

Secondary Outcomes (3)

• The improvement and improvement rate of the tester for the treatment response (Chi-square test or Fisher's Exact test)

  Visit 3 (7 day)

• The satisfaction of the subject (Questionnaire)

  Visit 3 (7 day)

• Total usage of Acetaminophen

  Visit 3 (7 day)

Study Arms (2)

Experimental

EXPERIMENTAL

HL301: 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment

Drug: HL301

Placebo comparator

PLACEBO COMPARATOR

HL301(Placebo): 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment

Drug: HL301(Placebo)

Interventions

HL301 DRUG

HL301: 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment

Experimental

HL301(Placebo) DRUG

HL301(Placebo): 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment

Placebo comparator

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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

Sponsors & Collaborators

• Hanlim Pharm. Co., Ltd.: lead

Study Sites (1)

Kyung Hee University Hospital

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

Location

MeSH Terms

Conditions

Bronchitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: September 8, 2017
• First Posted: October 16, 2017
• Study Start: March 29, 2017
• Primary Completion: August 17, 2017
• Study Completion: August 28, 2017
• Last Updated: October 16, 2017

Record last verified: 2017-10

Locations

KR (1)