RecruitingNot Applicable

The Role of the Nasal Allergen Provocation Test in Starting and Monitoring Allergen Immunotherapy

Belgium200 participantsStarted 2020-07-16

Plain-language summary

This prospective multicentric academic NAPT study aims to compile a database of all patients who initiate immunotherapy. The NAPT will take place before, during and after AIT to evaluate the cost and effectiveness of the treatment. The study consists of 4 visits and 2 telephone contacts that are repeated annually for 3 years. This study will be conducted in 2 hospitals: UZ Leuven and AZ ST. Jan Brugge on the consultation Ear, Nose and Throat Diseases (ENT) and the department of Internal Medicine / Allergology

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age \>18 and ≤60 years * Persistent or intermittent allergic rhinitis complaints, confirmed by SPT and/of immunocap for the specific IgEs. OR suspected local allergic rhinitis * Patients who start with AIT treatment * The patient must be motivated and willing to come to all visits * The patient must be able to understand and sign the informed consent Exclusion Criteria: * Uncontrolled asthma * Conditions affecting the functioning of the immune system (eg: immune deficiencies, malignancies, autoimmune diseases) * Use of β-blockers, immunosuppressants or ACE inhibitors * Hypersensitivity to aluminum hydroxide and/or hypersensitivity to any of the excipients in AIT * Anaphylaxis after allergen challenge in the past * Acute rhinosinusitis in the last 12 weeks * Recent surgery on the nose and/or paranasal sinuses in the last 12 weeks * Pregnancy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The effectiveness of AIT treatment assessed by the change in the blood concentration in total en specific IgE .

Timeframe: before start AIT, every 6 months en after 3 years

The effectiveness of AIT treatment assessed by the change in quality of life meassured by the Lebelscore.

Timeframe: Before start AIT, every 6 months en after 3 years

The effectiveness of AIT treatment assessed by the change in quality of life meassured by the SNOT-22.

Timeframe: Before start AIT, every 6 months en after 3 years

The effectiveness of AIT treatment assessed by the change in quality of life meassured by the VAS.

Timeframe: Before start AIT, every 6 months en after 3 years

The effectiveness of AIT treatment assessed by the change in quality of life meassured by the TNSS.

Timeframe: Before start AIT, every 6 months en after 3 years

The effectiveness of AIT treatment assessed by the change in quality of life meassured by the ACT.

Timeframe: Before start AIT, every 6 months en after 3 years

Trial details

NCT IDNCT04544774

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12

Contact for this trial

Margot Vandekerckhove

+3216332342 margot.vandekerckhove@uzleuven.be

View on ClinicalTrials.gov More Perennial Allergic Rhinitis trials