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 range18 Years – 60 Years

SexALL

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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

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

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

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