NCT03075917

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
14mo left

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress89%
May 2017Jul 2027

First Submitted

Initial submission to the registry

March 6, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 9, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

May 4, 2017

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

9.7 years

First QC Date

March 6, 2017

Last Update Submit

December 31, 2025

Conditions

Keywords

Allergic rhinitis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

self questionnaire for allergic rhinitis control

Experimental

Eligibility Criteria

Age5 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients that are already treated for the actual episode of allergic rhinitis and are satisfied of the treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CH Louis Pasteur

Bagnols-sur-Cèze, France

COMPLETED

Maison de santé de Lasalle

Lasalle, 30460, France

TERMINATED

CH de MILLAU

Millau, France

COMPLETED

Centre (Ctre) Medical Ravas - Malbosc

Montpellier, 34080, France

COMPLETED

University hospital of Montpellier

Montpellier, 34295, France

RECRUITING

Hôpital Trousseau,

Paris, France

COMPLETED

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Pascal DEMOLY, Professor

CONTACT

Anca CHIRIAC, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2017

First Posted

March 9, 2017

Study Start

May 4, 2017

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

January 5, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations