Observational Study of Allergic Rhinitis in Children (ORACLE)

September 30, 2025 updated by: ALK-Abelló A/S
Observational, cross-sectional, prospective, multicentric study in France with private paediatricians to describe the management of allergic rhinitis in children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Data collected about diagnostic, comorbidities, clinical history, management of allergic rhinitis using a patient paper case report form. There is only one visit per patient and investigators can include up to 20 patients.

Study Type

Observational

Enrollment (Actual)

1004

Contacts and Locations

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

Study Locations

  • France
      • Paris, France, 75015
        • Hôpital Necker-Enfants malades - AP-HP Service de Pneumologie et Allergologie Pédiatriques

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

1 year to 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

1000 patients aged 2 to 18 years old with allergic rhinitis

Description

Inclusion Criteria:

  • Under 18 years of age
  • With allergic rhinitis
  • Who's representative of the parental authority did not object to his child's participation after oral and written information and who agrees to participate

Exclusion Criteria:

  • Child or adolescent opposed to participate or collect his personal data

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of children over 2 years of age with allergic rhinitis eligible for allergic immunotherapy
Time Frame: 1 year
Descriptive analysis : evaluation with data collected in the case report form about allergic rhinitis
1 year

Collaborators and Investigators

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

Sponsor

ALK-Abelló A/S

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)

November 23, 2022

Primary Completion (Actual)

March 3, 2024

Study Completion (Actual)

March 3, 2024

Study Registration Dates

First Submitted

December 1, 2022

First Submitted That Met QC Criteria

December 9, 2022

First Posted (Actual)

December 19, 2022

Study Record Updates

Last Update Posted (Estimated)

October 3, 2025

Last Update Submitted That Met QC Criteria

September 30, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-A01596-37

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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