Clinical trial NCT04544774: The Role of the Nasal Allergen Provocation Test in Starting and Monitoring Allergen Immunotherapy
Official title: The Role of the Nasal Allergen Provocation Test in Starting and Monitoring Allergen Immunotherapy: An Academic Multicentre Clinical Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Perennial Allergic Rhinitis
Seasonal Allergic Rhinitis
Local Allergic Rhinitis
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: AZ Sint-Jan AV
First posted: 2020-09-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with persistent and intermittent allergic rhinitis who start with AIT treatment.

Brief 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


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

Primary outcomes:
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: The effectiveness of AIT treatment assessed by the change in quality of life meassured by the RQLQ.
timeFrame: Before start AIT, every 6 months en after 3 years
measure: The effectiveness of AIT treatment assessed by the change in quality of life meassured by the TRE.
timeFrame: Before start AIT, every 6 months en after 3 years
measure: The effectiveness of AIT treatment assessed by the change in the PNIF value.
timeFrame: Before start AIT, every 6 months en after 3 years
Secondary outcomes:
measure: Calculating the cost savings by desensitizing poly-sensitized patients only to the allergen to which they respond most strongly in the NAPT test.
timeFrame: 3 years
measure: 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.
timeFrame: 3 year
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaam Brabant
city: Brugge
country: Belgium
facility: AZ Sint-Jan
Study officials:
References: