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

Universitaire Ziekenhuizen KU Leuven

Status: Enrolling

Conditions: Local Allergic Rhinitis; Perennial Allergic Rhinitis; Seasonal Allergic Rhinitis

Treatments: Drug: AIT; Diagnostic Test: NAPT

Study type: Observational

Funder types: Other

Identifiers

NCT04544774

s63711

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

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.

Treatment:

Drug: AIT

Diagnostic Test: NAPT