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Completed

NCT Number: NCT02151734

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

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.

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Key information

Conditions

Acute Bronchitis Bronchial Diseases Bronchitis Infections Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

12 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KALOMIN™ Tab.

Drug

Umckamin syrup

Drug

Primary outcomes

  1. Total score of BSS(Bronchitis Severity Score)

    Time frame: 7days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Korea United Pharm. Inc.

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
First posted
May 30, 2014
Registry last updated
May 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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