Impacts of Nitrogen Deposition in the Natural Environment on Pollen Allergy in Belgium

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
Sponsorprof. dr. Rik Schrijvers

About this trial

The investigators want to study the effect of environmental nitrogen enrichment on the allergy burden in pollen-sensitized subjects.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Positive skin prick test for grass and/or birch pollen

Disqualifiers

Desensitization therapy during the last two years

Trial design

Design model

Parallel

Treatments tested in this trial

  • Immunoreactivity testing

    Diagnostic test

    Blood samples will be collected and used to determine the intensity of the allergenicity of the subject toward different types of pollen. This will be done by the detection of sIgE antibodies to the pollen extracts and basophil activation testing (BAT) with pollen extracts.

  • Immunoreactivity testing (negative control)

    Diagnostic test

    Blood samples will be collected and used to determine the background activity of our immunoreactivity tests. The investigators will use samples from negative controls to demonstrate that non-allergic individuals do not react to our assays, confirming that our pollen extracts have no background reactivity. This will be done by the detection of sIgE antibodies to the pollen extracts and basophil activation testing (BAT) with pollen extracts.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Allergic subjectsOther 1 intervention
Group B: Healthy controlsOther 1 intervention

Trial outcomes

Primary outcomes

1

Specific IgE reactivity (in-house developed) against environmental and experimental pollen samples

The investigators want to measure and compare sIgE values (kUA/L) towards different pollen samples.

Time frame
From time of inclusion to 12 months

Secondary outcomes

1

Basophil degranulation with different amounts of pollen on fresh patient-derived basophils.

The investigators want to measure and compare basophil degranulation with different pollen extracts on fresh patient-derived basophils. The investigators will use %CD63+ basophils as measure for basophil reactivity and sensitivity. The investigators will compare this between different pollen samples.

Time frame
From time of inclusion to 12 months
2

Overall intensity (quantitative) of IgE reactivity to pollen samples in a subset of patients.

The investigators will use an immunoblot to compare IgE mediated reactivity toward different pollen samples. Quantitatively, the investigators will compare band intensity (mean gray value) between different samples.

Time frame
From time of inclusion to 12 months
3

IgE-mediated hyper- or hyporecognition of different fragments in the pollen samples (qualitative) in a subset of patients.

The investigators will use an immunoblot to compare IgE mediated reactivity toward different pollen samples. Qualitatively, the investigators will compare presence of bands between samples.

Time frame
From time of inclusion to 12 months

Other outcomes

1

Association of allergic rhinoconjunctivitis symptoms with reactivity to different pollen samples (TNSS)

The Total Nasal Symptom Score (TNSS) is the sum of scores for each of nasal congestion, sneezing, nasal itching, and rhinorrhea at each time point, using a four point scale (0-3), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. TNSS is calculated by adding the score for each of the symptoms to a total out of 12.

Time frame
From time of inclusion to 12 months
2

Association of allergic rhinoconjunctivitis symptoms with reactivity to different pollen samples (VAS)

The rhinitis severity Visual analogue scale (VAS) is used to evaluate the overall severity of the rhinitis symptoms. The participant is asked to answer the several questions on: "How troublesome are your symptoms" on a 100mm VAS from 0 ('not troublesome') to 100 ('worst thinkable troublesome'). Based on their score on the VAS, the severity of rhinosinusitis can be divided into 3 categories as follows: Mild = VAS \<20 mm Moderate = VAS 20-50 Severe = VAS \>50

Time frame
From time of inclusion to 12 months
3

Association of allergic rhinoconjunctivitis symptoms with reactivity to different pollen samples (PFS)

Pollen-food syndrome (PFS) validated diagnostic questionnaire evaluates presence and severity of cross-reactivity. The diagnostic questionnaire and algorithm is a practical and robust tool, which enables rapid identification, and therefore management, of individuals with PFS who experience rhino-conjunctivitis symptoms in the birch pollen season. Evaluate association of cross-reactivity with reactivity to different pollen samples.

Time frame
From time of inclusion to 12 months
4

Association of allergic rhinoconjunctivitis symptoms with reactivity to different pollen samples (EQ-5D-5L)

Stress and well-being: evaluate impact on patients life - Quality of life (EuroQol 5 Dimensions, 5 Levels = EQ-5D-5L). Will be evaluated according to the standard guidelines. A worse rhinitis control and a worse asthma control are associated with higher EQ-5D-5L levels, particularly regarding pain/discomfort and activity impairment. Worse rhinitis control is associated with worse anxiety/depression, and poor asthma control with worse mobility. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the 5 dimensions. The digits for the 5 dimensions can be combined into a 5-digit number that describes the patient's health status.

Time frame
From time of inclusion to 12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

prof. dr. Rik Schrijvers

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Sponsor institution

Sciensano

Collaborator

KU Leuven

Collaborator

University of Namur

Collaborator

Université Catholique de Louvain

Collaborator