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CompletedNCT05655858ORACLEUpdated Oct 3, 2025

Observational Study of Allergic Rhinitis in Children

An observational study in Allergic Rhinitis, sponsored by ALK-Abelló A/S. Completed at 1 site in France. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-10-03.

Sponsored by ALK-Abelló A/S · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,004
Ages
2 Years to 18 Years
Sex
All
01

Study summary

Observational, cross-sectional, prospective, multicentric study in France with private paediatricians to describe the management of allergic rhinitis in children.

Read the 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.

02

Conditions studied

  • Allergic Rhinitis

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03

In context

Rhinitis, Allergic

717 studies on the registry are indexed under Rhinitis, Allergic; 94 are open to participants now.

This study's enrollment of 1,004 is above the median of 120 across 143 observational studies indexed under Rhinitis, Allergic.

Browse Rhinitis, Allergic studies →

Lead sponsor

ALK-Abelló A/S is the lead sponsor of 67 studies on the registry; 2 are open to participants now.

Browse ALK-Abelló A/S studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

1000 patients aged 2 to 18 years old with allergic rhinitis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Child or adolescent opposed to participate or collect his personal data
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,004 participants (actual)
Patient registry
No

Interventions

  • OtherManagement of allergic rhinitis

    Collection of patient data in real-life

06

What researchers measure

Primary outcomes

  1. Proportion of children over 2 years of age with allergic rhinitis eligible for allergic immunotherapy

    Descriptive analysis : evaluation with data collected in the case report form about allergic rhinitis

    Time frame: 1 year

07

Study locations

1 site
  • Hôpital Necker-Enfants malades - AP-HP Service de Pneumologie et Allergologie Pédiatriques
    Paris, 75015, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2022 to primary completion in Mar 2024, 15 months.

Of 49 observational studies under Rhinitis, Allergic, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 29. This study's 15 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 1, 2022
First posted
Dec 19, 2022
StartActual
Nov 23, 2022
Primary completionActual
Mar 3, 2024
CompletionActual
Mar 3, 2024
Last update
Oct 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05655858
Lead sponsor
ALK-Abelló A/S
Responsible party
Sponsor
First posted
Dec 19, 2022
Start date
Nov 23, 2022
Primary completion
Mar 3, 2024
Completion
Mar 3, 2024
Last update
Oct 3, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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