NCT02279706

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 31, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

May 2, 2016

Status Verified

April 1, 2016

Enrollment Period

11 months

First QC Date

October 17, 2014

Last Update Submit

April 28, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

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

    Check the Korean version of rhinitis controlled assessment tests

    up to 4weeks

Secondary Outcomes (1)

  • rhinitis-related quality of life

    up to 4weeks

Interventions

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.

Also known as: questionnaire(R-CAT-RQLQ)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

rhinitis within 12 months from the time of study enrollment.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou University Medical Center

Suwon, South Korea

Location

MeSH Terms

Conditions

Rhinitis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • hae sim park, professor

    Department of internal medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor, Department of allergic interal medicine

Study Record Dates

First Submitted

October 17, 2014

First Posted

October 31, 2014

Study Start

October 1, 2014

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

May 2, 2016

Record last verified: 2016-04

Locations