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Validation of an Allergic Rhinitis Control Test in Children (ARCTEnfants)

Primary Purpose

Allergic Rhinitis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Self Questionnaire
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Allergic Rhinitis focused on measuring Allergic rhinitis

Eligibility Criteria

5 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged 5 to 11 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 treatment.

Sites / Locations

  • CH Louis Pasteur
  • Maison de santé de Lasalle
  • CH de MILLAU
  • Centre (Ctre) Medical Ravas - Malbosc
  • University hospital of MontpellierRecruiting
  • Hôpital Trousseau,

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

questionnaire for allergic rhinitis control children from 5 to 11 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
Score of the allergic rhinitis control self questionnaire in teenagers from 5 to 11 years old.

Secondary Outcome Measures

Full Information

First Posted
March 6, 2017
Last Updated
July 17, 2023
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT03075917
Brief Title
Validation of an Allergic Rhinitis Control Test in Children
Acronym
ARCTEnfants
Official Title
Validation of an Allergic Rhinitis Control Test in Children
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 4, 2017 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
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 teenagers or in children. A study conducted in 2008, resulted in the validation of a self-administered control test of allergic rhinitis (ARCT) in patients from 12 years of age. We propose to adapt ARCT adult to pediatric population from 5 to 11 years old.

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
135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
questionnaire for allergic rhinitis control children from 5 to 11 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
Intervention Description
self questionnaire for allergic rhinitis control
Primary Outcome Measure Information:
Title
Score of the allergic rhinitis control self questionnaire
Description
Score of the allergic rhinitis control self questionnaire in teenagers from 5 to 11 years old.
Time Frame
15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 5 to 11 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 treatment.
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
CH Louis Pasteur
City
Bagnols-sur-Cèze
Country
France
Individual Site Status
Completed
Facility Name
Maison de santé de Lasalle
City
Lasalle
ZIP/Postal Code
30460
Country
France
Individual Site Status
Terminated
Facility Name
CH de MILLAU
City
Millau
Country
France
Individual Site Status
Completed
Facility Name
Centre (Ctre) Medical Ravas - Malbosc
City
Montpellier
ZIP/Postal Code
34080
Country
France
Individual Site Status
Completed
Facility Name
University hospital of Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal DEMOLY, Professor
Phone
+33 467336107
Email
pascal.demoly@inserm.fr
Facility Name
Hôpital Trousseau,
City
Paris
Country
France
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
No

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Validation of an Allergic Rhinitis Control Test in Children

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