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

NCT ID: NCT04544774

Last Updated: 2020-09-10

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-16

Study Completion Date

2025-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Perennial Allergic Rhinitis Seasonal Allergic Rhinitis Local Allergic Rhinitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

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

Intervention Type DRUG

AIT for airborn allergens (SCIT/SLIT)

NAPT

Intervention Type DIAGNOSTIC_TEST

NAPT test with airborn allergens ( HDM, Threes, Grasses)

Interventions

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AIT

AIT for airborn allergens (SCIT/SLIT)

Intervention Type DRUG

NAPT

NAPT test with airborn allergens ( HDM, Threes, Grasses)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AZ Sint-Jan AV

OTHER

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Laura Van Gerven

prof. dr. Laura Van Gerven

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UZ Leuven

Leuven, Vlaam Brabant, Belgium

Site Status RECRUITING

AZ Sint-Jan

Bruges, , Belgium

Site Status NOT_YET_RECRUITING

Countries

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Belgium

Central Contacts

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Margot Vandekerckhove

Role: CONTACT

+3216332342

Laura Van Gerven, PhD

Role: CONTACT

+3216336340

Facility Contacts

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Margot Vandekerckhove

Role: primary

+3216332342 ext. +3216332342

Laura Van Gerven

Role: backup

+3216336390 ext. +3216336340

Kato Speleman, MD

Role: primary

050452280

Other Identifiers

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s63711

Identifier Type: -

Identifier Source: org_study_id

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