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

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

Sponsors

Lead Sponsor: Universitaire Ziekenhuizen Leuven

Collaborator: AZ Sint-Jan AV

Source Universitaire Ziekenhuizen 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

Overall Status Recruiting
Start Date July 16, 2020
Completion Date December 2025
Primary Completion Date December 2025
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
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 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 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 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 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 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 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 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 assessed by the change in the PNIF value. Before start AIT, every 6 months en after 3 years
Secondary Outcome
Measure Time Frame
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
Enrollment 200
Condition
Intervention

Intervention Type: Drug

Intervention Name: AIT

Description: AIT for airborn allergens (SCIT/SLIT)

Arm Group Label: Allergic rhinitis patients

Intervention Type: Diagnostic Test

Intervention Name: NAPT

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

Arm Group Label: Allergic rhinitis patients

Eligibility

Sampling Method: Probability Sample

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Overall Contact

Last Name: Margot Vandekerckhove

Phone: +3216332342

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator:
UZ Leuven | Leuven, Vlaam Brabant, 3000, Belgium Recruiting Margot Vandekerckhove +3216332342 +3216332342 [email protected] Laura Van Gerven, MD, PhD Principal Investigator
AZ Sint-Jan | Brugge, 8000, Belgium Not yet recruiting Kato Speleman, MD 050452280 [email protected]
Location Countries

Belgium

Verification Date

September 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Universitaire Ziekenhuizen Leuven

Investigator Full Name: Laura Van Gerven

Investigator Title: prof. dr. Laura Van Gerven

Has Expanded Access No
Condition Browse
Arm Group

Label: Allergic rhinitis patients

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

Patient Data No
Study Design Info

Observational Model: Case-Only

Time Perspective: Prospective

Source: ClinicalTrials.gov