Comparative Real World Effectiveness of SQ Sublingual Immunotherapy (SLIT)-Tablets vs. Controls in Allergic Rhinitis and Asthma

NCT ID: NCT05476484

Last Updated: 2023-08-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 49844 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2024-06-30

Brief Summary

To assess the impact of SQ SLIT-tablets (SQ Grass SLIT-tablet and SQ HDM SLIT-tablet) in Danish and Swedish allergic rhinitis (AR) patients, with or without asthma, between 2007-2020.

Detailed Description

Allergic rhinitis (AR) is an inflammatory disorder, characterised by pruritus, sneezing, rhinorrhoea, and nasal congestion. It is one of the most common disorders worldwide, with an estimated global prevalence of 10-30%. AR is a chronic and progressive disease, as the underlying respiratory allergy can progress into allergic asthma. The prevalence of asthma in patients with AR is high and estimated between 10-40%. The presence of AR commonly exacerbates asthma, increasing the risk of asthma exacerbations, emergency visits and hospitalisations for asthma.

Recently, the high-quality retrospective cohort REACT study (ClinicalTrial.gov: NCT04125888) found that allergy immunotherapy (AIT) was associated with long-term reduction in AR medication use as well as significant reductions in both controller and reliever asthma medication and concurrent lower risk of asthma exacerbation and pneumonia in subjects with pre-existing asthma. The SQ sublingual immunotherapy (SLIT)-tablets have robust evidence from randomised controlled trials (RCTs), but real-world evidence (RWE) is needed to complement the findings from RCTs by looking at e.g. longer time horizons and broader patient populations. As the REACT study was not designed to specifically look at evidence-based AIT treatments like the SQ SLIT-tablets, the real-world effectiveness of SQ SLIT tablets remain to be further elucidated.

Conditions

Allergy; Allergic Rhinitis; Asthma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Allergic rhinitis patients with and without asthma treated with SQ SLIT-tablet

SQ SLIT-tablet

Intervention Type: DRUG

SQ grass SLIT-tablet and/or SQ house dust mite SLIT-tablet

Allergic rhinitis patients with and without asthma not treated with SQ SLIT-tablet

No interventions assigned to this group

Interventions

SQ SLIT-tablet

SQ grass SLIT-tablet and/or SQ house dust mite SLIT-tablet

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

AR-patients identified by dispensations of prescribed AR medications and/or ICD10-codes of AR in specialty care

For the SQ SLIT-tablet cohort:

• at least 2 dispensings within 365 days of SQ SLIT-tablets (ATC: V01AA02 and V01AA03)

For the control cohort:

• unexposed subjects will be identified from the study population of AR-patients that may be eligible to receive SQ SLIT-tablets, but have not dispensed a prescription of SQ SLIT-tablets during the index year of the case or prior to that year

Exclusion Criteria

• allergy immunotherapy treatment with grass or HDM allergens prior to the index event

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Quantify Research

UNKNOWN

Sponsor Role: collaborator

ALK-Abelló A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julie F Rask Larsen, MD PhD

Role: STUDY_DIRECTOR

ALK

Locations

ALK

Hørsholm, Copenhagen, Denmark

Countries

Denmark

Other Identifiers

NI-X-05

Identifier Type: -

Identifier Source: org_study_id