Actively Recruiting
The Role of the Nasal Allergen Provocation Test in Starting and Monitoring Allergen Immunotherapy: An Academic Multicentre Clinical Study
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-05-01
200
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
A
AZ Sint-Jan AV
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying patients with persistent or intermittent allergic rhinitis, including local allergic rhinitis, who are starting allergen immunotherapy (AIT). The study aims to compile a database of all patients undergoing immunotherapy and to evaluate the cost and effectiveness of treatment using the Nasal Allergen Provocation Test (NAPT). This observational study is conducted at two hospitals and focuses on patients confirmed by skin prick tests or immunocap for specific IgEs. Participants will undergo NAPT before, during, and after their AIT treatment, which targets airborne allergens such as house dust mite, trees, and grasses. The study involves four visits and two telephone contacts repeated annually for three years. The goal is to monitor the response to AIT and assess cost savings by targeting treatment to the allergen with the strongest response and by stopping treatment early in non-responders. During the study, patients will have blood tests measuring total and specific IgE levels, and their quality of life will be evaluated using several questionnaires including Lebel score, SNOT-22, VAS, TNSS, ACT, RQLQ, and TRE. Nasal airflow will be assessed by PNIF measurements. These assessments occur before AIT starts, every six months during treatment, and after three years. The study also tracks safety and treatment adherence throughout the participation period.
CONDITIONS
Brief Title
The Role of the Nasal Allergen Provocation Test in Starting and Monitoring Allergen Immunotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 and less than or equal to 60 years
- Persistent or intermittent allergic rhinitis confirmed by skin prick tests and/or immunocap for specific IgEs, or suspected local allergic rhinitis
- Patients who start allergen immunotherapy (AIT) treatment
- Motivation and willingness to attend all study visits
- Ability to understand and sign informed consent
You will not qualify if you...
- Uncontrolled asthma
- Conditions affecting immune system function such as immune deficiencies, malignancies, or autoimmune diseases
- Use of beta-blockers, immunosuppressants, or ACE inhibitors
- Hypersensitivity to aluminum hydroxide or any excipients in AIT
- History of anaphylaxis after allergen challenge
- Acute rhinosinusitis within the last 12 weeks
- Recent surgery on nose or paranasal sinuses within the last 12 weeks
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants receive allergen immunotherapy (AIT) and are monitored to assess treatment effectiveness.
Visits every 6 months for assessments
Duration - Up to 3 years
Participants undergo periodic assessments using the Nasal Allergen Provocation Test (NAPT) and quality of life measures to monitor treatment response and guide therapy adjustments.
Visits every 6 months for assessments
Trial Site Locations
Total: 2 locations
1
UZ Leuven
Leuven, Vlaam Brabant, Belgium, 3000
Actively Recruiting
2
AZ Sint-Jan
Bruges, Belgium, 8000
Not Yet Recruiting
Research Team
M
Margot Vandekerckhove
L
Laura Van Gerven, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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