Allergic RhinitisRELYNCT05476484
Comparative Real World Effectiveness of SQ Sublingual Immunotherapy (SLIT)-Tablets vs. Controls in Allergic Rhinitis and Asthma
An observational study of Allergic Rhinitis and Asthma, run by ALK-Abelló A/S at 1 site in Denmark.
Trial 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 more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Allergic Rhinitis, Asthma, Allergy
- What is being tested?
- SQ SLIT-tablet
- Type of treatment
- Pill or oral medicine
- How many people
- 46,196 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2022to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Any allergy immunotherapy treatment prior to the index event
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Real World-effectiveness of SQ Sublingual Immunotherapy (SLIT)-Tablets in Subjects With Allergic Rhinitis With or Without Asthma: Results From a Multinational, Retrospective Register Study
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.
- Conditions
- Allergic Rhinitis, Asthma, Allergy
- Being tested
- SQ SLIT-tablet
- Keywords
- Allergy immunotherapy, Sublingual immunotherapy (SLIT)-tablets, Grass, House dust mite, Retrospective cohort study, register-based
- Medical subject headings
- Rhinitis, Allergic, Asthma, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SQ SLIT-tabletDrug
SQ grass SLIT-tablet and/or SQ house dust mite SLIT-tablet
| Study group | Role | What they receive |
|---|---|---|
| Allergic rhinitis patients with and without asthma treated with SQ SLIT-tablet | Not described Receives: Drug: SQ SLIT-tablet | |
| Allergic rhinitis patients with and without asthma not treated with SQ SLIT-tablet | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom-relieving medication use for allergic rhinitis
Overall number of prescriptions and by individual drug classes (prescribed products containing INCS or prescribed antihistamines )
Measured: From pre-index to follow-up year(s), assessed from 2005 and up to 2021
Secondary outcomes (3)
Medication use for asthma
Overall number of prescriptions and by individual drug classes
Measured: 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
Measured: 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
Measured: From pre-index to follow-up year(s), assessed from 2005 and up to 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start1 Apr 2022
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 46,196 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quantify Research
- Responsible party
- Sponsor
- Investigators
- Sana Hussein, MSc, Study director, ALK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476484
- Sponsor's protocol ID
- NI-X-05
- Acronym
- RELY
- Status last verified
- Jul 2023
- First submitted
- 29 Jun 2022
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Real World-effectiveness of SQ Sublingual Immunotherapy (SLIT)-Tablets in Subjects With Allergic Rhinitis With or Without Asthma: Results From a Multinational, Retrospective Register Study
- ClinicalTrials.gov ID
- NCT05476484
- Acronym / sponsor ID
- RELY / NI-X-05
- Conditions
- Allergic Rhinitis, Asthma, Allergy
- Keywords
- Allergy immunotherapy, Sublingual immunotherapy (SLIT)-tablets, Grass, House dust mite, Retrospective cohort study, register-based
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46,196 participants (actual)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Collaborators
- Quantify Research
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 27 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
- at least 2 dispensations within 365 days of SQ SLIT-tablets (ATC: V01AA02 and V01AA03)
- 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
Key exclusion criteria (1 listed)
- Any allergy immunotherapy treatment prior to the index event
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SQ SLIT-tabletSQ grass SLIT-tablet and/or SQ house dust mite SLIT-tablet | Drug | Allergic rhinitis patients with and without asthma treated with SQ SLIT-tablet |
Primary outcome
Symptom-relieving medication use for allergic rhinitis
Time frame: From pre-index to follow-up year(s), assessed from 2005 and up to 2021
Overall number of prescriptions and by individual drug classes (prescribed products containing INCS or prescribed antihistamines )
3 secondary outcomes
Medication use for asthma
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sana Hussein, MSc study director
ALK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinitis and Asthma, run by ALK-Abelló A/S at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom-relieving medication use for allergic rhinitis (time frame: From pre-index to follow-up year(s), assessed from 2005 and up to 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.