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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Korea United Pharm. Inc.
ClinicalTrials.gov Identifier:
NCT02151734
First received: May 28, 2014
Last updated: NA
Last verified: May 2014
History: No changes posted
  Purpose

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: Double Blind (Subject, Caregiver, 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

  Eligibility

Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Study First Received: May 28, 2014
Last Updated: May 28, 2014

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

ClinicalTrials.gov processed this record on March 24, 2017