About this trial
The ClimAIr project will expand the evidence-based understanding of climate change, air pollution, and non-communicable respiratory diseases by using Artificial Intelligence (AI) tools. It will gather data on greenhouse gases levels and disaster risks, information on serious air pollutants and respiratory diseases' prevalence. The AI powered tools will be employed to generate better intervention methods and improve public health outcomes.
Federated Learning (FL) will be used to develop AI models to protect patients' privacy. By raising public awareness and delivering the ClimAIr tool - specifically designed to health workers, urban planners and policy makers - the project aims to influence policy decisions, promote healthier environments, and reduce respiratory diseases in Europe, which will be tested and validated the ClimAIr tool in specific municipalities that are part of the project. ClimAIr draws on a consortium of 21 partners from 15 European countries, including carefully selected health centres across Europe - in Spain, Luxembourg, Ukraine, Italy, France, Germany, Greece, Romania and Poland - focused on respiratory diseases, which will provide disease data and explore metabolic routes of the studied contaminants/diseases. ClimAIr is composed of an interdisciplinary team formed by research centres, ethical AI and modelling experts, SSH specialists, municipal governance, and a Communication \& Dissemination (C\&D) expert team dedicated to achieving and spread the results of the project.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with health insurance based in Malaga, Milan, Luxembourg, Thessalonikki, Lodz, Berlin, Toulousse, Chervnivtsi and Brasov (the places where environmental/climate information will be obtained from, only one recruitment place for partner).
3-year history of chronic rhinitis symptoms during the corresponding pollen season, while residing in the same household AND attending the same school/college or holding the same job position.
Positive SPT and serum allergen-specific IgE >0.35 kUA/L. The pollen species driving the nasal symptoms will be Olea europaea, Phleum pratense or Betula pendula.
Patients can be sensitized to other aeroallergens if the nasal symptoms occur exclusively or aggravate unequivocally during the pollen season of the three allergens of interest.
Disqualifiers
None
Trial population
Pacients with 3-year history of chronic rhinitis symptoms during the corresponding pollen seasonp ositive SPT and serum allergen-specific IgE \>0.35 kUA/L.
Trial design
Other
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Mean Symptom Score of Allergic Rhinitis Patients by Environmental Exposure
Mean allergic rhinitis symptom scores retrieved from electronic health records (EHR), stratified by environmental exposure levels (pollutants and climate factors), using the Observational Medical Outcomes Partnership (OMOP) common data model.
Proteomic Biomarker Levels (NPX) by Environmental Exposure
Proteomic profiles measured using Olink® assays in serum and nasal lavage of allergic rhinitis patients, stratified by environmental exposure.
Secondary outcomes
SO1: Effect of air pollution on adaptive immune responses to allergenic pollen
Evaluation of the immune response of peripheral blood mononuclear cells (PBMCs) from allergic rhinitis patients exposed to different environmental conditions, after in vitro stimulation with pollen samples previously exposed to varying pollution levels. The response will be characterized by proliferation of allergen-specific lymphocyte subsets and cytokine production.
SO1: Proliferative responses of allergen-specific lymphocytes to pollen exposed to pollution
Measurement of lymphocyte proliferation using CFSE-labeled PBMCs incubated with pollen (Olea europaea, Phleum pratense, Betula pendula) grown under different pollution conditions.
SO1: Cytokine release from allergen-specific lymphocytes in response to polluted pollen
Quantification of cytokines released in the supernatants of PBMC cultures stimulated with pollen under different pollution conditions. A multiplex ELISA panel will be used to measure Th1, Th2, Th9, and regulatory cytokine
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Lead sponsor
Theramed Healthcare SRL (Romania)
Collaborator
Centre Hospitalier Universitaire de Toulouse, FRANCE
Collaborator
Charite-Universitaetsmedizin Berlin (Germany)
Collaborator
Aristotelio Panepistimio Thessalonikis (Greece)
Collaborator
Uniwersytet Medyczny w Lodzi (Poland)
Collaborator
Universita degli Studi di Milano (Italy)
Collaborator
Bukovinian State Medical University (Ukraine)
Collaborator
Luxembourg Institute of Health
Collaborator
Andaluz Health Service
Collaborator
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