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CompletedNCT05476484RELYUpdated Jul 20, 2026

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

An observational study in Allergic Rhinitis, Asthma and Allergy, sponsored by ALK-Abelló A/S. Completed at 1 site in Denmark. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2026-07-20.

Sponsored by ALK-Abelló A/S · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
46,196
Ages
5 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Allergic Rhinitis
  • Asthma
  • Allergy

Keywords

  • Allergy immunotherapy
  • Sublingual immunotherapy (SLIT)-tablets
  • Grass
  • House dust mite
  • Retrospective cohort study
  • register-based
03

In context

Rhinitis, Allergic

717 studies on the registry are indexed under Rhinitis, Allergic; 94 are open to participants now.

This study's enrollment of 46,196 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 and older
Sexes eligible
All
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

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

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

Exclusion Criteria:

- Any allergy immunotherapy treatment prior to the index event

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
46,196 participants (actual)
Patient registry
No

Groups and cohorts

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

    Drug: SQ SLIT-tablet

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

Interventions

  • DrugSQ SLIT-tablet

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

06

What researchers measure

Primary outcomes

  1. Symptom-relieving medication use for allergic rhinitis

    Overall number of prescriptions and by individual drug classes (prescribed products containing INCS or prescribed antihistamines )

    Time frame: From pre-index to follow-up year(s), assessed from 2005 and up to 2021

Secondary outcomes

  1. Medication use for asthma

    Overall number of prescriptions and by individual drug classes

    Time frame: From pre-index to follow-up year(s), assessed from 2005 and up to 2021

  2. 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

  3. 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

Other outcomes

  1. 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

  2. Health care resource utilisation assessed by hospitalisations

    Time frame: From pre-index to follow-up year(s), assessed from 2005 and up to 2021

  3. Health care resource utilisation assessed by cost

    Time frame: From pre-index to follow-up year(s), assessed from 2005 and up to 2021

07

Study locations

1 site
  • ALK
    Hørsholm, Copenhagen DK-2970, Denmark
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2022 to primary completion in Jun 2024, 26 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 29, 2022
First posted
Jul 27, 2022
StartActual
Apr 1, 2022
Primary completionActual
Jun 30, 2024
CompletionActual
Jun 30, 2024
Last update
Jul 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05476484
Lead sponsor
ALK-Abelló A/S
Collaborators
Quantify Research
Responsible party
Sponsor
First posted
Jul 27, 2022
Start date
Apr 1, 2022
Primary completion
Jun 30, 2024
Completion
Jun 30, 2024
Last update
Jul 20, 2026

Study contacts

Sana Hussein, MSc
study director · ALK

Oversight

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

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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