- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02818153
Validation of an Allergic Rhinitis Control Test in Teenagers (ARCTado)
Allergic rhinitis is a common condition that affects adults as well as children and adolescents, often with impaired quality of life. Patients often report a poor level of satisfaction with the effectiveness of their treatment and are always looking for more drug combinations to improve their symptom. Several tools exist for assessing control of allergic rhinitis, but none has been validated in adolescents or in children. A study conducted in 2008, resulted in the validation of a self-administered control test of allergic rhinitsis (ARCT) in patients from 12 years of age. However, this study included only 67 adolescents aged 12 to 17 years old and lacked power.
In this new study,the investigators propose, following exactly the same procedure as the pilot study of 2008, to confirme the validation of unmodified Adult questionnaire in adolescents 12 to 17 years inclusive.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Montpellier, France, 34295
- University Hospital of Montpellier
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Contact:
- Pascal Demoly
- Phone Number: +33 467336107
- Email: pascal.demoly@inserm.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients aged 12 to 17 years old, consulting a practitioner for an allergic rhinitis
- parents formulated their study participation agreement by signing the consent form.
Exclusion Criteria:
- Patients that are already treated for the actual episode of allergic rhinitis and are satisfied of the treatement.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: questionnaire for allergic rhinitis control
Teenagers from 12 to 17 years old who complete a Self questionnaire regarding allergic rhinitis control during the consultation and after 15 days
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Score of the allergic rhinitis control self questionnaire in teenagers from 12 to 17 years old.
Time Frame: 15 days
|
15 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9614
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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