Back to resultsValidation of an Allergic Rhinitis Control Test in Teenagers (ARCTado)
Primary Purpose
Allergic Rhinitis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Self questionnaire for allergic rhinitis control
Sponsored by
About this trial
This is an interventional prevention trial for Allergic Rhinitis focused on measuring Allergic rhinitis
Eligibility Criteria
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.
Sites / Locations
- University hospital of Montpellier
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
questionnaire for allergic rhinitis control
Arm Description
Teenagers from 12 to 17 years old who complete a Self questionnaire regarding allergic rhinitis control during the consultation and after 15 days
Outcomes
Primary Outcome Measures
Score of the allergic rhinitis control self questionnaire in teenagers from 12 to 17 years old.
Secondary Outcome Measures
Full Information
NCT ID
NCT02818153
First Posted
June 27, 2016
Last Updated
June 28, 2016
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT02818153
Brief Title
Validation of an Allergic Rhinitis Control Test in Teenagers
Acronym
ARCTado
Official Title
Validation of an Allergic Rhinitis Control Test in Teenagers
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
Keywords
Allergic rhinitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
questionnaire for allergic rhinitis control
Arm Type
Experimental
Arm Description
Teenagers from 12 to 17 years old who complete a Self questionnaire regarding allergic rhinitis control during the consultation and after 15 days
Intervention Type
Other
Intervention Name(s)
Self questionnaire for allergic rhinitis control
Primary Outcome Measure Information:
Title
Score of the allergic rhinitis control self questionnaire in teenagers from 12 to 17 years old.
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pascal Demoly, Professor
Phone
+334 67 33 61 27
Email
pascal.demoly@inserm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Anca Chiriac, MD
Email
a-chiriac@chu-montpellier.fr
Facility Information:
Facility Name
University hospital of Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal Demoly
Phone
+33 467336107
Email
pascal.demoly@inserm.fr
12. IPD Sharing Statement
Plan to Share IPD
No
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Validation of an Allergic Rhinitis Control Test in Teenagers
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