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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: May 30, 2014
Last Update Posted: May 30, 2014
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.
Information provided by (Responsible Party):
Korea United Pharm. Inc.

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 Intervention Phase
Acute Bronchitis Drug: KALOMIN™ Tab. Drug: Umckamin syrup Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Korea United Pharm. Inc.:

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

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

Enrollment: 242
Study Start Date: August 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Senior)
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Korea United Pharm. Inc.
ClinicalTrials.gov Identifier: NCT02151734     History of Changes
Other Study ID Numbers: KUP-KLM_301
First Submitted: May 28, 2014
First Posted: May 30, 2014
Last Update Posted: May 30, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Acute Disease
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes