The Role of the Nasal Allergen Provocation Test in Starting and Monitoring Allergen Immunotherapy
Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Sep 3, 2020
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how a specific test, called the Nasal Allergen Provocation Test (NAPT), can help doctors start and monitor treatment for allergic rhinitis, which is a condition that causes sneezing, a runny nose, and other allergy symptoms. The trial aims to gather information from patients who are beginning a type of treatment known as allergen immunotherapy (AIT) at two hospitals. Overall, the study will include four visits and two phone calls each year for three years to see how effective the treatment is and how much it costs.
To participate, individuals need to be between 18 and 60 years old and have symptoms of allergic rhinitis confirmed through allergy tests. They should also be starting AIT and willing to attend all study visits. However, those with uncontrolled asthma, certain immune system conditions, or specific allergies may not be eligible. Participants will have the opportunity to learn more about their allergies and how to manage them effectively throughout the study.
Gender
ALL
Eligibility 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
About Universitaire Ziekenhuizen Ku Leuven
Universitaire Ziekenhuizen KU Leuven is a leading academic medical center in Belgium, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. Affiliated with KU Leuven, one of Europe’s premier universities, the institution integrates cutting-edge scientific inquiry with high-quality patient care. It plays a pivotal role in the development and implementation of clinical trials, fostering collaboration between researchers, healthcare professionals, and industry partners to translate scientific discoveries into effective treatments. The hospital's multidisciplinary approach ensures comprehensive patient safety and ethical standards, positioning it as a trusted sponsor in the realm of clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Brugge, , Belgium
Leuven, Vlaam Brabant, Belgium
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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