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

Seasonal Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04544774
• Other study ID #: s63711
• Status: Recruiting
• Start date: July 16, 2020
• Est. completion date: December 2025

Study information

• Verified date: September 2020
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Margot Vandekerckhove
• Phone: +3216332342
• Email: margot.vandekerckhove[@]uzleuven.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Local Allergic Rhinitis
• Perennial Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Perennial
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• AIT
AIT for airborn allergens (SCIT/SLIT)

Diagnostic Test:
• NAPT
NAPT test with airborn allergens ( HDM, Threes, Grasses)

Locations

Country	Name	City	State
Belgium	AZ Sint-Jan	Brugge
Belgium	UZ Leuven	Leuven	Vlaam Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	AZ Sint-Jan AV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	before start AIT, every 6 months en after 3 years
Primary	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.	Before start AIT, every 6 months en after 3 years
Primary	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.	Before start AIT, every 6 months en after 3 years
Primary	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.	Before start AIT, every 6 months en after 3 years
Primary	The effectiveness of AIT treatment assessed by the change in quality of life meassured by the TNSS.	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.	Before start AIT, every 6 months en after 3 years
Primary	The effectiveness of AIT treatment assessed by the change in quality of life meassured by the ACT.	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.	Before start AIT, every 6 months en after 3 years
Primary	The effectiveness of AIT treatment assessed by the change in quality of life meassured by the RQLQ.	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.	Before start AIT, every 6 months en after 3 years
Primary	The effectiveness of AIT treatment assessed by the change in quality of life meassured by the TRE.	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'.	Before start AIT, every 6 months en after 3 years
Primary	The effectiveness of AIT treatment assessed by the change in the PNIF value.	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.	Before start AIT, every 6 months en after 3 years
Secondary	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
Secondary	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