Safety and Efficacy of KALOMIN™ Tab. in Patients With Acute Bronchitis

This is a multi-center, double-dummy, double-blind, randomized, active-controlled, parallel group phase 3 clinical trial to evaluate the efficacy and safety of KALOMIN™ Tab. in patients with acute bronchitis.

The aim of this clinical trial is to demonstrate that KALOMIN™ Tab. is clinically non-inferior to Umckamin syrup, as assessed by BSS(Bronchitis Severity Score), in the treatment of acute bronchitis after 7 days.

Study Overview

• Status: Completed
• Conditions: Acute Bronchitis
• Intervention / Treatment: Drug: KALOMIN™ Tab.; Drug: Umckamin syrup

• Study Type: Interventional
• Enrollment (Actual): 242
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female patients aged 12-75 years old
• A total score of BSS ≥ 5
• The duration of symptoms had to be less than 14 days and no chronic pulmonary disease
• Patients who voluntarily sign a written informed consent to participate in the trial

Exclusion Criteria:

• Indication for antibiotic treatment(e.g. severe respiratory infection)
• Allergic bronchial asthma
• Tendency to bleed
• Severe heart, renal, or liver diseases or decline of immune function
• Chronic obstructive pulmonary disease
• Known or supposed hypersensitivity to investigational medication
• Treatment with antibiotics during the past 4 weeks prior to inclusion in the trial
• Women during pregnancy or lactation period
• Clinically significant abnormal values in the screening test(more than twice the upper limit of normal range for ALT, AST, BUN, and Serum Creatinine)
• Participation in any other trial within 30 days prior to inclusion in the trial
• Unsuitable patients for enrollment in the opinion of the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KALOMIN™ Tab.; KALOMIN™ Tab./Placebo to Umckamin syrup	Drug: KALOMIN™ Tab.
Active Comparator: Umckamin syrup; Umckamin syrup/Placebo to KALOMIN™ Tab.	Drug: Umckamin syrup

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total score of BSS(Bronchitis Severity Score)	7days

Secondary Outcome Measures

Outcome Measure	Time Frame
Individual symptom score of BSS	7days
reaction rate of treatment	7days
IMOS(Integrative Medicine Outcome Scale)	7days
IMPSS(Integrative Medicine Patient Satisfaction Scale)	7days
Adverse events, clinical laboratory examination, physical examination, etc.	7 days

Collaborators and Investigators

• Sponsor: Korea United Pharm. Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: May 28, 2014
• First Submitted That Met QC Criteria: May 28, 2014
• First Posted (Estimate): May 30, 2014

Study Record Updates

• Last Update Posted (Estimate): May 30, 2014
• Last Update Submitted That Met QC Criteria: May 28, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis
• Other Study ID Numbers: KUP-KLM_301