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 volunteersQualifiers
Positive skin prick test for grass and/or birch pollen
Disqualifiers
Desensitization therapy during the last two years
Trial design
Parallel
Treatments tested in this trial
Immunoreactivity testing
Diagnostic testBlood 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 testBlood 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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
Other outcomes
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.
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
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.
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.
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