NCT05476484

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
49,844

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

August 2, 2023

Status Verified

July 1, 2023

Enrollment Period

2.2 years

First QC Date

June 29, 2022

Last Update Submit

July 31, 2023

Conditions

AllergyAllergic RhinitisAsthma

Keywords

Allergy immunotherapySublingual immunotherapy (SLIT)-tabletsGrassHouse dust miteRetrospective cohort study

Outcome Measures

Primary Outcomes (1)

  • Symptom-relieving medication use for allergic rhinitis

    Overall number of prescriptions and by individual drug classes

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

Secondary Outcomes (3)

  • Medication use for asthma

    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

    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

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

Other Outcomes (3)

  • Health care resource utilisation assessed by ambulatory care visits

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

  • Health care resource utilisation assessed by hospitalisations

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

  • Health care resource utilisation assessed by cost

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

Study Arms (2)

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

SQ SLIT-tabletDRUG

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

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

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

AR-patients identified by dispensations of prescribed AR medications and/or ICD10-codes of AR in specialty care

You may qualify if:

  • 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

You may not qualify if:

  • \- allergy immunotherapy treatment with grass or HDM allergens prior to the index event

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ALK

Hørsholm, Copenhagen, DK-2970, Denmark

Location

MeSH Terms

Conditions

HypersensitivityRhinitis, AllergicAsthma

Condition Hierarchy (Ancestors)

Immune System DiseasesRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateBronchial DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Julie F Rask Larsen, MD PhD

    ALK

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2022

First Posted

July 27, 2022

Study Start

April 1, 2022

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

August 2, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)