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Korean Linguistic Adaptation of Rhinitis Controlled Assessment Test (R-CAT)

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.
 
ClinicalTrials.gov Identifier: NCT02279706
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : May 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hae-Sim Park, Ajou University School of Medicine

Brief Summary:
Korean linguistic adaptation of Rhinitis controlled assessment test (RCAT).

Condition or disease Intervention/treatment
Rhinitis Other: questionnaire

Detailed Description:
Check the Korean version of rhinitis controlled assessment tests, the total non-symptom scores (total nasal symptoms score, TNSS), rhinitis-related quality of life (RQLQ), rhinitis controlled degree, severity, and after study enrollment and 4 weeks treatment.

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Study Type : Observational
Actual Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Linguistic Adaptation of Rhinitis Control Assessment Test (RCAT) in Korean and Responsiveness to Disease Severity, Quality of Life, and Treatment in Adult Rhinitis Patients: A Multicenter Prospective Study
Study Start Date : October 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup


Intervention Details:
  • Other: questionnaire
    Check the Korean version of rhinitis controlled assessment tests, the total non-symptom scores (total nasal symptoms score, TNSS), rhinitis-related quality of life (RQLQ), rhinitis controlled degree, severity, and after study enrollment and 4 weeks treatment.
    Other Name: questionnaire(R-CAT-RQLQ)


Primary Outcome Measures :
  1. Korean linguistic adaptation of Rhinitis controlled assessment test (RCAT) [ Time Frame: up to 4weeks ]
    Check the Korean version of rhinitis controlled assessment tests


Secondary Outcome Measures :
  1. rhinitis-related quality of life [ Time Frame: up to 4weeks ]
    rhinitis-related quality of life (RQLQ)check up to 24 weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
rhinitis within 12 months from the time of study enrollment.
Criteria

Inclusion Criteria:

  1. Adults over 19 years
  2. Past medical history and allergy skin test or who have been diagnosed with allergic or non-allergic rhinitis, based on serum specific immunoglobulin E .
  3. People who have experienced symptoms of rhinitis within 12 months from the time of study enrollment.
  4. People who have rhinitis symptoms requiring medication at the time of study enrollment.
  5. People who can read and write korea language.
  6. People who signed a written consent form approved by the Institutional Review Board of their respective organizations to participate in this study freely hearing to explain fully the purpose for the contents of this study prior to participation in research.

Exclusion Criteria:

  1. People diagnosed with Rhinitis medicamentosa.
  2. People determined that bacterial or viral respiratory infection at the time of study enrollment.
  3. People who have evidence of nasal infection
  4. People associated anatomical abnormality that causes severe nasal congestion as deviation of nasal septum.
  5. People determined that acute or chronic sinusitis according to the researchers determined.
  6. In case that pregnancy test is positive, or ambiguous conclusions among female patients.
  7. people deemed unsuitable for clinical trial participation due to other reasons.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279706


Locations
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Korea, Republic of
Ajou University Medical Center
Suwon, Korea, Republic of
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
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Principal Investigator: hae sim park, professor Department of internal medicine

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Responsible Party: Hae-Sim Park, professor, Department of allergic interal medicine, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT02279706    
Other Study ID Numbers: MED-OBS-14-158
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: May 2, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases