NCT02818153

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 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

June 29, 2016

Status Verified

June 1, 2016

Enrollment Period

3 months

First QC Date

June 27, 2016

Last Update Submit

June 28, 2016

Conditions

Keywords

Allergic rhinitis

Outcome Measures

Primary Outcomes (1)

  • Score of the allergic rhinitis control self questionnaire in teenagers from 12 to 17 years old.

    15 days

Study Arms (1)

questionnaire for allergic rhinitis control

EXPERIMENTAL

Teenagers from 12 to 17 years old who complete a Self questionnaire regarding allergic rhinitis control during the consultation and after 15 days

Other: Self questionnaire for allergic rhinitis control

Interventions

questionnaire for allergic rhinitis control

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital of Montpellier

Montpellier, 34295, France

Location

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

June 27, 2016

First Posted

June 29, 2016

Study Start

June 1, 2016

Primary Completion

September 1, 2016

Study Completion

June 1, 2017

Last Updated

June 29, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations