Validation of an Allergic Rhinitis Control Test in Teenagers

Allergic Rhinitis Clinical Trial

— ARCTado  

Official title:

Validation of an Allergic Rhinitis Control Test in Teenagers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02818153
• Other study ID #: 9614
• Status: Not yet recruiting
• Phase: N/A
• First received: June 27, 2016
• Last updated: June 28, 2016
• Start date: June 2016
• Est. completion date: June 2017

Study information

• Verified date: June 2016
• Source: University Hospital, Montpellier
• Contact: Pascal Demoly, Professor
• Phone: +334 67 33 61 27
• Email: pascal.demoly[@]inserm.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Other:
• Self questionnaire for allergic rhinitis control

Locations

Country	Name	City	State
France	University hospital of Montpellier	Montpellier

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 in teenagers from 12 to 17 years old.		15 days	No