Korean Linguistic Adaptation of Rhinitis Controlled Assessment Test

Rhinitis Clinical Trial

— R-CAT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02279706
• Other study ID #: MED-OBS-14-158
• Status: Completed
• Phase: N/A
• First received: October 17, 2014
• Last updated: April 28, 2016
• Start date: October 2014
• Est. completion date: October 2015

Study information

• Verified date: April 2016
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Rhinitis

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Medical Center	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Korean linguistic adaptation of Rhinitis controlled assessment test (RCAT)	Check the Korean version of rhinitis controlled assessment tests	up to 4weeks	No
Secondary	rhinitis-related quality of life	rhinitis-related quality of life (RQLQ)check up to 24 weeks	up to 4weeks	No