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Allergy tablets under the tongue may cut hay fever drug use for years, massive real-world study suggests

NCT ID NCT05476484

Disease control Sponsor: ALK-Abelló A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time

Summary

This study looks back at health records from over 46,000 people in Denmark and Sweden with allergic rhinitis (hay fever), some of whom also have asthma. It compares those who used SQ sublingual immunotherapy (SLIT) tablets — a daily tablet placed under the tongue containing grass pollen or house dust mite allergens — to similar people who did not. The goal is to see whether long-term use of these tablets reduces the need for symptom-relieving allergy and asthma medications and lowers the risk of asthma attacks or lung infections.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SQ sublingual immunotherapy (SLIT) tablets containing grass pollen or house dust mite allergens
What this could lead to
If successful, this could confirm that allergy tablets are a practical, long-term option for controlling allergic rhinitis and reducing reliance on symptom-relieving drugs.
What could go wrong
Because this is a retrospective register study, it can show associations but not prove cause and effect. Results may be influenced by differences between people who chose treatment and those who did not.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

46,196 people

The number who actually took part.

Started

Apr 2022

Finished

Jun 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

5 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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

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Conditions

The condition(s) this trial relates to.

allergic disease allergic rhinitis asthma Rhinitis, Allergic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Allergic rhinitis Allergy Asthma

Contacts and locations

Locations

  • ALK

    Hørsholm, Copenhagen, DK-2970, Denmark

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