ARCTEnfants: Validation of an Allergic Rhinitis Control Test in Children

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Recruiting

CT.gov ID

NCT03075917

Collaborator

(none)

100

Enrollment

Locations

Arm

73.9

Anticipated Duration (Months)

16.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Allergic Rhinitis	Other: Self Questionnaire	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Validation of an Allergic Rhinitis Control Test in Children

Actual Study Start Date :

May 4, 2017

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental 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	Other: Self Questionnaire self questionnaire for allergic rhinitis control

Arm

Intervention/Treatment

Experimental: Experimental

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

Other: Self Questionnaire

self questionnaire for allergic rhinitis control

Outcome Measures

Primary Outcome Measures

Score of the allergic rhinitis control self questionnaire [15 days]
Score of the allergic rhinitis control self questionnaire in teenagers from 5 to 11 years old.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 11 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CH Louis Pasteur	Bagnols-sur-Cèze	France
2	Maison de santé de Lasalle	Lasalle	France	30460
3	CH de MILLAU	Millau	France
4	Centre (Ctre) Medical Ravas - Malbosc	Montpellier	France	34080
5	University hospital of Montpellier	Montpellier	France	34295
6	Hôpital Trousseau,	Paris	France

Sponsors and Collaborators

University Hospital, Montpellier

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Montpellier

ClinicalTrials.gov Identifier:

NCT03075917

Other Study ID Numbers:

9762

First Posted:

Mar 9, 2017

Last Update Posted:

Dec 23, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Montpellier

Allergic rhinitis

Additional relevant MeSH terms:

Rhinitis

Rhinitis, Allergic

Study Results

No Results Posted as of Dec 23, 2021