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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02151734
Recruitment Status : Completed
First Posted : May 30, 2014
Last Update Posted : May 30, 2014
Information provided by (Responsible Party):
Korea United Pharm. Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Bronchitis Drug: KALOMIN™ Tab. Drug: Umckamin syrup Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 242 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : August 2013
Actual Primary Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acute Bronchitis

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

Primary Outcome Measures :
  1. Total score of BSS(Bronchitis Severity Score) [ Time Frame: 7days ]

Secondary Outcome Measures :
  1. Individual symptom score of BSS [ Time Frame: 7days ]
  2. reaction rate of treatment [ Time Frame: 7days ]
  3. IMOS(Integrative Medicine Outcome Scale) [ Time Frame: 7days ]
  4. IMPSS(Integrative Medicine Patient Satisfaction Scale) [ Time Frame: 7days ]
  5. Adverse events, clinical laboratory examination, physical examination, etc. [ Time Frame: 7 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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Responsible Party: Korea United Pharm. Inc. Identifier: NCT02151734    
Other Study ID Numbers: KUP-KLM_301
First Posted: May 30, 2014    Key Record Dates
Last Update Posted: May 30, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections