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

Korea United Pharm

Status and phase

Completed

Phase 3

Conditions

Acute Bronchitis

Treatments

Drug: KALOMIN™ Tab.

Drug: Umckamin syrup

Study type

Interventional

Funder types

Industry

Identifiers

NCT02151734

KUP-KLM_301

Details and patient eligibility

About

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.

Enrollment

242 patients

Sex

All

Ages

12 to 75 years old

Volunteers

No Healthy Volunteers

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