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

July 17, 2026 updated by: ALK-Abelló A/S

Long-term Real World-effectiveness of SQ Sublingual Immunotherapy (SLIT)-Tablets in Subjects With Allergic Rhinitis With or Without Asthma: Results From a Multinational, Retrospective Register Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

46196

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen
      • Hørsholm, Copenhagen, Denmark, DK-2970
        • ALK

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

AR-patients identified by having at least two dispensations of prescribed AR medications for two consecutive years and/or ICD10-codes of AR in specialty care

Description

Inclusion Criteria:

AR-patients identified by having at least two dispensations of prescribed AR medications for two consecutive years and/or ICD10-codes of AR in specialty care

For the SQ SLIT-tablet cohort:

- at least 2 dispensations 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:

- Any allergy immunotherapy treatment prior to the index event

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Allergic rhinitis patients with and without asthma treated with SQ SLIT-tablet
Drug: SQ SLIT-tablet
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom-relieving medication use for allergic rhinitis
Time Frame: From pre-index to follow-up year(s), assessed from 2005 and up to 2021
Overall number of prescriptions and by individual drug classes (prescribed products containing INCS or prescribed antihistamines )
From pre-index to follow-up year(s), assessed from 2005 and up to 2021

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication use for asthma
Time Frame: From pre-index to follow-up year(s), assessed from 2005 and up to 2021
Overall number of prescriptions and by individual drug classes
From pre-index to follow-up year(s), assessed from 2005 and up to 2021
Asthma disease severity assessed by reliever and controller medication prescriptions and hospitalisations due to asthma
Time Frame: From pre-index to follow-up year(s), assessed from 2005 and up to 2021
From pre-index to follow-up year(s), assessed from 2005 and up to 2021
Lower airway infections assessed by prescriptions of antibiotics and diagnosis codes for pneumonia
Time Frame: From pre-index to follow-up year(s), assessed from 2005 and up to 2021
From pre-index to follow-up year(s), assessed from 2005 and up to 2021

Other Outcome Measures

Outcome Measure
Time Frame
Health care resource utilisation assessed by ambulatory care visits
Time Frame: From pre-index to follow-up year(s), assessed from 2005 and up to 2021
From pre-index to follow-up year(s), assessed from 2005 and up to 2021
Health care resource utilisation assessed by hospitalisations
Time Frame: From pre-index to follow-up year(s), assessed from 2005 and up to 2021
From pre-index to follow-up year(s), assessed from 2005 and up to 2021
Health care resource utilisation assessed by cost
Time Frame: From pre-index to follow-up year(s), assessed from 2005 and up to 2021
From pre-index to follow-up year(s), assessed from 2005 and up to 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ALK-Abelló A/S

Collaborators

Quantify Research

Investigators

  • Study Director: Sana Hussein, MSc, ALK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

June 29, 2022

First Submitted That Met QC Criteria

July 25, 2022

First Posted (Actual)

July 27, 2022

Study Record Updates

Last Update Posted (Actual)

July 20, 2026

Last Update Submitted That Met QC Criteria

July 17, 2026

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NI-X-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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