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
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.
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.
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 →ALK-Abelló A/S is the lead sponsor of 67 studies on the registry; 2 are open to participants now.
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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.
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
Drug: SQ SLIT-tablet
SQ grass SLIT-tablet and/or SQ house dust mite SLIT-tablet
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
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
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
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
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
Health care resource utilisation assessed by hospitalisations
Time frame: 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
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2022 to primary completion in Jun 2024, 26 months.
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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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