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

Overview

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

Full Title of Study: “The Role of the Nasal Allergen Provocation Test in Starting and Monitoring Allergen Immunotherapy: An Academic Multicentre Clinical Study”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2025

Interventions

  • Drug: AIT
    • AIT for airborn allergens (SCIT/SLIT)
  • Diagnostic Test: NAPT
    • NAPT test with airborn allergens ( HDM, Threes, Grasses)

Arms, Groups and Cohorts

  • Allergic rhinitis patients
    • Patients with persistent or intermittent allergic rhinitis complaints, confirmed by skin prick tests and/or immunocap for specific IgEs, that start with AIT treatment.

Clinical Trial Outcome Measures

Primary Measures

  • The effectiveness of AIT treatment assessed by the change in the blood concentration in total en specific IgE .
    • Time Frame: before start AIT, every 6 months en after 3 years
    • The effectiveness of AIT treatment will be analysed by comparing blood results, assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up).
  • The effectiveness of AIT treatment assessed by the change in quality of life meassured by the Lebelscore.
    • Time Frame: Before start AIT, every 6 months en after 3 years
    • The effectiveness of AIT treatment will be analysed by comparing the Lebelscores ,assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up). Lebelscore has a range between 0 and 12.
  • The effectiveness of AIT treatment assessed by the change in quality of life meassured by the SNOT-22.
    • Time Frame: Before start AIT, every 6 months en after 3 years
    • The effectiveness of AIT treatment will be analysed by comparing SNOT-22, assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up). SNOT-22 is sino-nasal outcome test with 22 items which ranges from 0 to 110.
  • The effectiveness of AIT treatment assessed by the change in quality of life meassured by the VAS.
    • Time Frame: Before start AIT, every 6 months en after 3 years
    • The effectiveness of AIT treatment will be analysed by comparing VAS, assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up). The visual analogue scale (VAS) ranges from 0 to 10cm for every item.
  • The effectiveness of AIT treatment assessed by the change in quality of life meassured by the TNSS.
    • Time Frame: Before start AIT, every 6 months en after 3 years
    • The effectiveness of AIT treatment will be analysed by comparing TNSS, assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up). Total nasal symptom score (TNSS) ranges from 0 to 12.
  • The effectiveness of AIT treatment assessed by the change in quality of life meassured by the ACT.
    • Time Frame: Before start AIT, every 6 months en after 3 years
    • The effectiveness of AIT treatment will be analysed by comparing ACT, assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up). ACT is the Asthma control test with scores between 0 and 25. The higher the score the better.
  • The effectiveness of AIT treatment assessed by the change in quality of life meassured by the RQLQ.
    • Time Frame: Before start AIT, every 6 months en after 3 years
    • The effectiveness of AIT treatment will be analysed by comparing RQLQ, assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up). RQLQ is the rhinoconjunctivits quality of life questionnaire with scores between 0 and 168. The higher the score of these questionnaires the more discomfort.
  • The effectiveness of AIT treatment assessed by the change in quality of life meassured by the TRE.
    • Time Frame: Before start AIT, every 6 months en after 3 years
    • The effectiveness of AIT treatment will be analysed by comparing TRE, assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up). TRE is the therapeutic response evaluation and will be scored between ‘much better’ and ‘much worse’.
  • The effectiveness of AIT treatment assessed by the change in the PNIF value.
    • Time Frame: Before start AIT, every 6 months en after 3 years
    • The effectiveness of AIT treatment will be analysed by comparing PNIF values assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up). PNIF is the peak nasal inspiratory flow with a value between 0 and 370 l/min). The higher the value the less congested the nose is.

Secondary Measures

  • Calculating the cost savings by desensitizing poly-sensitized patients only to the allergen to which they respond most strongly in the NAPT test.
    • Time Frame: 3 years
  • Calculating the cost savings by timely stopping AIT treatment in non-responders, which we can define as patients who do not experience subjective or objective improvement after 1 year of treatment.
    • Time Frame: 3 year

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Investigator Details

  • Lead Sponsor
    • Universitaire Ziekenhuizen KU Leuven
  • Collaborator
    • AZ Sint-Jan AV
  • Provider of Information About this Clinical Study
    • Principal Investigator: Laura Van Gerven, prof. dr. Laura Van Gerven – Universitaire Ziekenhuizen KU Leuven
  • Overall Contact(s)
    • Margot Vandekerckhove, +3216332342, margot.vandekerckhove@uzleuven.be

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