Clinical Trials to Assess the Efficacy and Safety of HLIM

Acute Bronchitis Clinical Trial

Official title:

Phase III Clinical Trials to Assess the Efficacy and Safety of HLIM for Symptomatic Relief of Cough and Sputum in Patients With Acute Upper Respiratory Tract Infection or Acute Bronchitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03827590
• Other study ID #: HLIM(SA16002)
• Status: Recruiting
• Phase: Phase 3
• Start date: November 29, 2018
• Est. completion date: October 31, 2019

Study information

• Verified date: February 2019
• Source: SamA Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy and safety of HLIM

Description:

A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 487
• Est. completion date: October 31, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age between 2 and 75

• Weight more than 11.5 kg

Exclusion Criteria:

• Has a history of hypersensitivity to IP ingredients

• Hypertension or Diabetes

• Smoking more than 20 pack-years

Related Conditions & MeSH terms

• Acute Bronchitis
• Acute Disease
• Acute Upper Respiratory Tract Infection
• Bronchitis
• Infection
• Respiratory Tract Infections

Intervention

Drug:
• Test
three times a day for five days
• Active Comparator Control 1
three times a day for five days
• Active Comparator Control 2
three times a day for five days
• Placebo
three times a day for five days

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul	Guro-gu

Sponsors (1)

Lead Sponsor	Collaborator
SamA Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in BSS(Bronchitis Severity Score)-cough domain of active comparator control 2 versus placebo	0(absent) ~ 4(very severe), Total Score: 0~20	5 days
Primary	Changes in BSS(Bronchitis Severity Score) total score of each active comparator control group compared to the test group	0(absent) ~ 4(very severe), Total Score: 0~20	5 days