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NCT Number: NCT04544774

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

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

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Key information

Conditions

Perennial Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Local Allergic Rhinitis Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Perennial Rhinitis, Allergic, Seasonal Seasonal Allergic Rhinitis

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven, Leuven, Vlaam Brabant, Belgium

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AIT

Drug

AIT for airborn allergens (SCIT/SLIT)

NAPT

Diagnostic Test

NAPT test with airborn allergens ( HDM, Threes, Grasses)

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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'.

  9. 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 outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Van Gerven, PhD

CONTACT

[email protected]

+3216336340

Margot Vandekerckhove

CONTACT

[email protected]

+3216332342

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • AZ Sint-Jan AV

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2020
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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