NCT05476484

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

Comparative Real World Effectiveness of SQ Sublingual Immunotherapy (SLIT)-Tablets vs. Controls in Allergic Rhinitis and Asthma - Outcomes From a Multinational Register Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 49,844 (estimated)
• Sponsor: ALK-Abelló A/S · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	SQ SLIT-tablet	SQ grass SLIT-tablet and/or SQ house dust mite SLIT-tablet

Timeline

• Start date: 2022-04-01
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2022-07-27
• Last updated: 2023-08-02

Locations

1 site across 1 country: Denmark

Regulatory

• FDA-regulated drug study