Evaluating the Nasal Allergen Provocation Test for Allergen Immunotherapy
The Role of the Nasal Allergen Provocation Test in Starting and Monitoring Allergen Immunotherapy: An Academic Multicentre Clinical Study
This study is trying to see how well a nasal allergy test works for people starting treatment for allergic rhinitis and if it can help improve their care over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 2 sites (Leuven, Vlaam Brabant and 1 other locations) |
| Trial ID | NCT04544774 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a comprehensive database of patients starting allergen immunotherapy (AIT) for allergic rhinitis. Participants will undergo a nasal allergen provocation test (NAPT) before, during, and after AIT to assess the treatment's cost-effectiveness and efficacy. The study involves four visits and two annual telephone contacts over three years, conducted at two hospitals specializing in ENT and Allergology. The goal is to monitor patient responses and improve treatment strategies for allergic rhinitis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 with persistent or intermittent allergic rhinitis confirmed by specific tests.
Not a fit: Patients with uncontrolled asthma, immune system disorders, or recent surgeries affecting the nasal area may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the effectiveness and personalization of allergen immunotherapy for patients with allergic rhinitis.
How similar studies have performed: Previous studies have shown promise in using similar approaches to monitor and improve allergen immunotherapy outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Leuven, Vlaam Brabant and 1 other locations
- UZ Leuven — Leuven, Vlaam Brabant, Belgium (Recruiting)
- AZ Sint-Jan — Bruges, Belgium (Not_yet_recruiting)
Study contacts
- Study coordinator: Margot Vandekerckhove
- Email: margot.vandekerckhove@uzleuven.be
- Phone: +3216332342
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.