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

• Sponsor: ALK-Abelló A/S (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05476484
• Collaborator: Quantify Research (Other)
• Enrollment: 40,000
• Location: 1
• Anticipated Duration (Months): 9
• Patients Per Site Per Month: 4443.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Allergy; Allergic Rhinitis; Asthma	Drug: SQ SLIT-tablet

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 Design

• Study Type: Observational
• Anticipated Enrollment: 40000 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Comparative Real World Effectiveness of SQ Sublingual Immunotherapy (SLIT)-Tablets vs. Controls in Allergic Rhinitis and Asthma - Outcomes From a Multinational Register Study
• Actual Study Start Date: Apr 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Symptom-relieving medication use for allergic rhinitis [From pre-index to follow-up year(s), assessed from 2005 and up to 2020]

   Overall number of prescriptions and by individual drug classes

Secondary Outcome Measures

1. Medication use for asthma [From pre-index to follow-up year(s), assessed from 2005 and up to 2020]

   Overall number of prescriptions and by individual drug classes

2. Asthma disease severity assessed by reliever and controller medication prescriptions and hospitalisations due to asthma [From pre-index to follow-up year(s), assessed from 2005 and up to 2020]

3. Lower airway infections assessed by prescriptions of antibiotics and diagnosis codes for pneumonia [From pre-index to follow-up year(s), assessed from 2005 and up to 2020]

Other Outcome Measures

1. Health care resource utilisation assessed by ambulatory care visits [From pre-index to follow-up year(s), assessed from 2005 and up to 2020]

2. Health care resource utilisation assessed by hospitalisations [From pre-index to follow-up year(s), assessed from 2005 and up to 2020]

3. Health care resource utilisation assessed by cost [From pre-index to follow-up year(s), assessed from 2005 and up to 2020]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ALK	Hørsholm	Copenhagen	Denmark	DK-2970

Sponsors and Collaborators

• ALK-Abelló A/S
• Quantify Research

Investigators

• Study Director: Julie F Rask Larsen, MD PhD, ALK

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ALK-Abelló A/S
• ClinicalTrials.gov Identifier: NCT05476484
• Other Study ID Numbers: NI-X-05
• First Posted: Jul 27, 2022
• Last Update Posted: Jul 27, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by ALK-Abelló A/S: Allergy immunotherapy; Sublingual immunotherapy (SLIT)-tablets; Grass; House dust mite; Retrospective cohort study
• Additional relevant MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic

Study Results

No Results Posted as of Jul 27, 2022