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

Acute Bronchitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02151734
• Other study ID #: KUP-KLM_301
• Status: Completed
• Phase: Phase 3
• First received: May 28, 2014
• Last updated: May 28, 2014
• Start date: August 2013

Study information

• Verified date: May 2014
• Source: Korea United Pharm. Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Bronchitis
• Acute Disease
• Bronchitis

Intervention

Drug:
• KALOMIN™ Tab.

• Umckamin syrup

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Korea United Pharm. Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total score of BSS(Bronchitis Severity Score)		7days	No
Secondary	Individual symptom score of BSS		7days	No
Secondary	reaction rate of treatment		7days	No
Secondary	IMOS(Integrative Medicine Outcome Scale)		7days	No
Secondary	IMPSS(Integrative Medicine Patient Satisfaction Scale)		7days	No
Secondary	Adverse events, clinical laboratory examination, physical examination, etc.		7 days	Yes