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

December 31, 2025 updated by: University Hospital, Montpellier
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

135

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bagnols-sur-Cèze, France
        • Completed
        • CH Louis Pasteur
      • Lasalle, France, 30460
        • Terminated
        • Maison de santé de Lasalle
      • Millau, France
        • Completed
        • CH de MILLAU
      • Montpellier, France, 34295
        • Recruiting
        • University Hospital of Montpellier
        • Contact:
      • Montpellier, France, 34080
        • Completed
        • Centre (Ctre) Medical Ravas - Malbosc
      • Paris, France
        • Completed
        • Hôpital Trousseau,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 11 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score of the allergic rhinitis control self questionnaire
Time Frame: 15 days
Score of the allergic rhinitis control self questionnaire in teenagers from 5 to 11 years old.
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2017

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

March 6, 2017

First Submitted That Met QC Criteria

March 6, 2017

First Posted (Actual)

March 9, 2017

Study Record Updates

Last Update Posted (Actual)

January 5, 2026

Last Update Submitted That Met QC Criteria

December 31, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL16_0283

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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