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RecruitingNCT05881577Updated May 31, 2023

The Effect of Allergic Rhinitis on Educational Outcomes

An observational study in Allergic Rhinitis, sponsored by ALK-Abelló A/S. Recruiting at 1 site in Denmark. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2023-05-31.

Sponsored by ALK-Abelló A/S · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2023, 3 years 3 months ago, but the record still lists the study as recruiting.
  • Started Feb 2023; still recruiting 3 years 8 months later.
Study type
Observational
Model
Case-control
Time perspective
Other
Enrollment
150,000
Ages
5 Years to 12 Years
Sex
All
01

Study summary

The study will assess the the burden of living with allergic rhinitis (AR) and the effect of AR on school performance for children and adolescents in Denmark.

Read the detailed description

The aim of the study is to investigate the effect of AR on school performance and examination test grades for children and adolescents diagnosed with AR early in life, as well as analyse their burden of disease and healthcare resource use using real-world data from the exhaustive Danish population registers. This is a retrospective registry analysis that uses Danish registers during 1994 and 2021.

In Denmark, national registers collect data for the entire Danish population from birth to death and have done so for decades. This exhaustive data creates a sound foundation for this study of the impact of school performance caused by AR, as subjects can be traced with high certainty and detail over several years.

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 planned enrollment of 150,000 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.

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

04

Who can participate

Ages eligible
5 Years to 12 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

children who have been diagnosed with AR before turning 13

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

  • The main study population (cases) consists of children who have been diagnosed with AR before turning 13. Diagnosis of AR will be identified by dispensations of prescribed AR medications, ICD-10 codes of AR-related hospitalisations and reimbursement codes for AR-related healthcare contacts in the primary healthcare sector.

At least two dispensed prescriptions of product containing intranasal (INCS) or antihistamines during the same calendar year for two consecutive years OR at least one visit with the primary healthcare sector with registered AR consultations AND at least one dispensed prescriptions of product containing INCS or antihistamines OR at least one contact with the hospital sector with an ICD-10 code for AR (primary or secondary diagnosis).

Exclusion criteria

Exclusion Criteria:

  • Children with their first AR-related healthcare contact or first AR-specific dispensed prescription at the age of 13 or older will be excluded.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Case-control
Time perspective
Other
Enrollment
150,000 participants (estimated)
Target follow-up
25 Years
Patient registry
Yes

Groups and cohorts

  • Cases

    The primary study population will consist of subjects with AR

    Other: Observational

  • Matched controls

    children with no history of AR

  • Sibling controls

    siblings of the subjects in the case group with no history of AR

Interventions

  • OtherObservational

    Impact of AR on educational outcomes

06

What researchers measure

Primary outcomes

  1. Primary school final examination test grades (oral and written) in: Language (Danish, English), Mathematics Obtained high school degree Obtained university degree

    Test grades

    Time frame: 1994-2021

Secondary outcomes

  1. Cost of inpatient and outpatient hospitalisation

    Cost in DKK

    Time frame: 1994-2021

  2. Cost of prescription medicine

    Cost in DKK

    Time frame: 1994-2021

  3. Number of inpatient and outpatient visits

    The number of inpatient/outpatients visits per year.

    Time frame: 1994-2021

07

Study locations

1 of 1 sites recruiting
  • ALK Abello
    Hørsholm, Hovedstaden 2970, Denmark
    Recruiting
    • Mercedes Romano, PharmD MBA · ContactMRRDK@ALK.NET · +4522971265
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05881577
Lead sponsor
ALK-Abelló A/S
Collaborators
Ernst & Young
Responsible party
Sponsor
First posted
May 31, 2023
Start date
Feb 15, 2023
Primary completion
Jul 31, 2023 (estimated)
Completion
Jul 31, 2023 (estimated)
Last update
May 31, 2023

Study contacts

Mercedes Romano, Pharm D, MBA
Contact
MRRDK@ALK.NET
+4522971265
Mikkel H Pedersen
Contact
Mikkel.H.Pedersen@dk.ey.com
+4560177416

Oversight

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

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