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

ConditionsPerennial Allergic RhinitisSeasonal Allergic RhinitisLocal Allergic Rhinitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >18 and ≤60 years

Persistent or intermittent allergic rhinitis complaints, confirmed by SPT and/of immunocap for the specific IgEs.

Patients who start with AIT treatment

The patient must be motivated and willing to come to all visits

Disqualifiers

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

Trial population

Patients with persistent and intermittent allergic rhinitis who start with AIT treatment.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • AIT

    Drug

    AIT for airborn allergens (SCIT/SLIT)

  • NAPT

    Diagnostic test

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

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Allergic rhinitis patients2 interventions

Trial outcomes

Primary outcomes

1

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

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).

Time frame
before start AIT, every 6 months en after 3 years
2

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

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.

Time frame
Before start AIT, every 6 months en after 3 years
3

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

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.

Time frame
Before start AIT, every 6 months en after 3 years
4

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

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.

Time frame
Before start AIT, every 6 months en after 3 years

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitaire Ziekenhuizen KU Leuven

Lead sponsor

AZ Sint-Jan AV

Collaborator

Source ClinicalTrials.gov
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