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Recruiting NCT04544774

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

— Observational Perennial Allergic Rhinitis Seasonal Allergic Rhinitis Local Allergic Rhinitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AIT, NAPT.
Who it may be relevant to
Registry conditions: Perennial Allergic Rhinitis, Seasonal Allergic Rhinitis, Local Allergic Rhinitis. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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

Interventions

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

Primary outcome 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 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 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 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 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 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 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 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 assessed by the change in the PNIF value. [Time frame: Before start AIT, every 6 months en after 3 years]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-only

Study locations

Belgium · 2 centers
  • UZ Leuven — Leuven
  • AZ Sint-Jan — Bruges

Identifiers

NCT: NCT04544774 · s63711

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗