The Effect of Allergic Rhinitis on Educational Outcomes

Allergic Rhinitis Clinical Trial

Official title:

The Effect of Allergic Rhinitis on Educational Outcomes - a Register-based Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05881577
• Other study ID #: NI-X-06
• Status: Recruiting
• Start date: February 15, 2023
• Est. completion date: July 31, 2023

Study information

• Verified date: May 2023
• Source: ALK-Abelló A/S
• Contact: Mercedes Romano, Pharm D, MBA
• Phone: +4522971265
• Email: MRRDK[@]ALK.NET
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150000
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Other:
• Observational
Impact of AR on educational outcomes

Locations

Country	Name	City	State
Denmark	ALK Abello	Hørsholm	Hovedstaden

Sponsors (2)

Lead Sponsor	Collaborator
ALK-Abelló A/S	Ernst & Young

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary school final examination test grades (oral and written) in: Language (Danish, English), Mathematics Obtained high school degree Obtained university degree	Test grades	1994-2021
Secondary	Cost of inpatient and outpatient hospitalisation	Cost in DKK	1994-2021
Secondary	Cost of prescription medicine	Cost in DKK	1994-2021
Secondary	Number of inpatient and outpatient visits	The number of inpatient/outpatients visits per year.	1994-2021