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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Korea United Pharm. Inc.

Criteria

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