Validation of an Allergic Rhinitis Control Test in Children

Allergic Rhinitis Clinical Trial

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Official title:

Validation of an Allergic Rhinitis Control Test in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03075917
• Other study ID #: 9762
• Status: Recruiting
• Phase: N/A
• Start date: May 4, 2017
• Est. completion date: July 2025

Study information

• Verified date: July 2023
• Source: University Hospital, Montpellier
• Contact: Pascal DEMOLY, Professor
• Phone: +334 67 33 61 27
• Email: pascal.demoly[@]inserm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: July 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Other:
• Self Questionnaire
self questionnaire for allergic rhinitis control

Locations

Country	Name	City	State
France	CH Louis Pasteur	Bagnols-sur-Cèze
France	Maison de santé de Lasalle	Lasalle
France	CH de MILLAU	Millau
France	Centre (Ctre) Medical Ravas - Malbosc	Montpellier
France	University hospital of Montpellier	Montpellier
France	Hôpital Trousseau,	Paris

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score of the allergic rhinitis control self questionnaire	Score of the allergic rhinitis control self questionnaire in teenagers from 5 to 11 years old.	15 days