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

Recruiting

• Conditions: Perennial Allergic Rhinitis; Seasonal Allergic Rhinitis; Local Allergic Rhinitis
• Interventions: Drug: AIT; Diagnostic Test: NAPT

• Registration Number: NCT04544774
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-16
• Study First Submitted: 2020-08-19
• Status Verified: 2020-09
• Study First Submitted QC: 2020-09-03
• Last Update Submitted: 2020-09-03
• Study First Posted: 2020-09-10
• Last Update Posted: 2020-09-10
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The effectiveness of AIT treatment assessed by the change in the blood concentration in total en specific IgE .	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 RQLQ.	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 SNOT-22.	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 TNSS.	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 Lebelscore.	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 VAS.	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 TRE.	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.	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.
The effectiveness of AIT treatment assessed by the change in quality of life meassured by the ACT.	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.

Secondary Outcome Measures

Name	Time	Method
Calculating the cost savings by desensitizing poly-sensitized patients only to the allergen to which they respond most strongly in the NAPT test.	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.	3 year

Trial Locations

Locations (2)

UZ Leuven; 🇧🇪 Leuven, Vlaam Brabant, Belgium

AZ Sint-Jan; 🇧🇪 Brugge, Belgium