RecruitingNCT04544774

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

Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

200 participants

Start Date

Jul 16, 2020

Study Type

OBSERVATIONAL

Conditions

Seasonal Allergic Rhinitis Perennial Allergic Rhinitis Local Allergic Rhinitis

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

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria6

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 Criteria8

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