RhinitisR-CATNCT02279706
Korean Linguistic Adaptation of Rhinitis Controlled Assessment Test
An observational study of Rhinitis, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
Korean linguistic adaptation of Rhinitis controlled assessment test (RCAT). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Rhinitis
- What is being tested?
- questionnaire
- How many people
- 130 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2014to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: rhinitis within 12 months from the time of study enrollment.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Korean linguistic adaptation of Rhinitis controlled assessment test (RCAT).
Read the 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.
- Conditions
- Rhinitis
- Being tested
- questionnaire
- Medical subject headings
- Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
Also called questionnaire(R-CAT-RQLQ)
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Korean linguistic adaptation of Rhinitis controlled assessment test (RCAT)
Check the Korean version of rhinitis controlled assessment tests
Measured: up to 4weeks
Secondary outcomes (1)
rhinitis-related quality of life
rhinitis-related quality of life (RQLQ)check up to 24 weeks
Measured: up to 4weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hae-Sim Park, Ajou University School of Medicine
- Investigators
- hae sim park, professor, Principal investigator, Department of internal medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279706
- Sponsor's protocol ID
- MED-OBS-14-158
- Acronym
- R-CAT
- Status last verified
- Apr 2016
- First submitted
- 17 Oct 2014
- Last updated
- 2 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02279706
- Acronym / sponsor ID
- R-CAT / MED-OBS-14-158
- Conditions
- Rhinitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 31 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Korean linguistic adaptation of Rhinitis controlled assessment test (RCAT).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- rhinitis within 12 months from the time of study enrollment.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaireAlso: questionnaire(R-CAT-RQLQ)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 | – |
Primary outcome
Korean linguistic adaptation of Rhinitis controlled assessment test (RCAT)
Time frame: up to 4weeks
Check the Korean version of rhinitis controlled assessment tests
1 secondary outcome
rhinitis-related quality of life
Time frame: up to 4weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2016.
Related trials for Rhinitis
Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingObservational study
A Study to Evaluate Treating Watery Noses With Cryotherapy in the Clinic Setting. This is Cold Therapy, Freezing the Issues at the Back of the Nose to Ease Symptoms.
Chronic Rhinitis
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hae sim park, professor principal investigator
Department of internal medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhinitis, run by Ajou University School of Medicine at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Korean linguistic adaptation of Rhinitis controlled assessment test (RCAT) (time frame: up to 4weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2016.