- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02279706
Korean Linguistic Adaptation of Rhinitis Controlled Assessment Test (R-CAT)
April 28, 2016 updated by: Hae-Sim Park, Ajou University School of Medicine
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
Korean linguistic adaptation of Rhinitis controlled assessment test (RCAT).
Study Overview
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.
Study Type
Observational
Enrollment (Actual)
130
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Suwon, Korea, Republic of
- Ajou University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
rhinitis within 12 months from the time of study enrollment.
Description
Inclusion Criteria:
- Adults over 19 years
- Past medical history and allergy skin test or who have been diagnosed with allergic or non-allergic rhinitis, based on serum specific immunoglobulin E .
- People who have experienced symptoms of rhinitis within 12 months from the time of study enrollment.
- People who have rhinitis symptoms requiring medication at the time of study enrollment.
- People who can read and write korea language.
- 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:
- People diagnosed with Rhinitis medicamentosa.
- People determined that bacterial or viral respiratory infection at the time of study enrollment.
- People who have evidence of nasal infection
- People associated anatomical abnormality that causes severe nasal congestion as deviation of nasal septum.
- People determined that acute or chronic sinusitis according to the researchers determined.
- In case that pregnancy test is positive, or ambiguous conclusions among female patients.
- people deemed unsuitable for clinical trial participation due to other reasons.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Korean linguistic adaptation of Rhinitis controlled assessment test (RCAT)
Time Frame: up to 4weeks
|
Check the Korean version of rhinitis controlled assessment tests
|
up to 4weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
rhinitis-related quality of life
Time Frame: up to 4weeks
|
rhinitis-related quality of life (RQLQ)check up to 24 weeks
|
up to 4weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: hae sim park, professor, Department of Internal Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
October 17, 2014
First Submitted That Met QC Criteria
October 29, 2014
First Posted (Estimate)
October 31, 2014
Study Record Updates
Last Update Posted (Estimate)
May 2, 2016
Last Update Submitted That Met QC Criteria
April 28, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MED-OBS-14-158
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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