The Effect of Allergic Rhinitis on Educational Outcomes

NCT ID: NCT05881577

Last Updated: 2023-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-15

Study Completion Date

2023-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Allergic Rhinitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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Cases

The primary study population will consist of subjects with AR

Observational

Intervention Type OTHER

Impact of AR on educational outcomes

Matched controls

children with no history of AR

No interventions assigned to this group

Sibling controls

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

No interventions assigned to this group

Interventions

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Observational

Impact of AR on educational outcomes

Intervention Type OTHER

Eligibility Criteria

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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 corticosteroids (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

* Children with their first AR-related healthcare contact or first AR-specific dispensed prescription at the age of 13 or older will be excluded.
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ernst & Young

UNKNOWN

Sponsor Role collaborator

ALK-Abelló A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ALK Abello

Hørsholm, Capital Region, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Mercedes Romano, Pharm D, MBA

Role: CONTACT

+4522971265

Mikkel H Pedersen

Role: CONTACT

+4560177416

Facility Contacts

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Mercedes Romano, PharmD MBA

Role: primary

+4522971265

Other Identifiers

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NI-X-06

Identifier Type: -

Identifier Source: org_study_id

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