The Role of the Nasal Allergen Provocation Test in Starting and Monitoring Allergen Immunotherapy
NCT ID: NCT04544774
Last Updated: 2020-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2020-07-16
2025-12-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Allergic rhinitis patients
Patients with persistent or intermittent allergic rhinitis complaints, confirmed by skin prick tests and/or immunocap for specific IgEs, that start with AIT treatment.
AIT
AIT for airborn allergens (SCIT/SLIT)
NAPT
NAPT test with airborn allergens ( HDM, Threes, Grasses)
Interventions
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AIT
AIT for airborn allergens (SCIT/SLIT)
NAPT
NAPT test with airborn allergens ( HDM, Threes, Grasses)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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AZ Sint-Jan AV
OTHER
Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Laura Van Gerven
prof. dr. Laura Van Gerven
Locations
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UZ Leuven
Leuven, Vlaam Brabant, Belgium
AZ Sint-Jan
Bruges, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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s63711
Identifier Type: -
Identifier Source: org_study_id
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