ClimAIr: AI to Assess the Impact of Pollution and Climate on Respiratory Health in Europe

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorFundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

1,906 Participants
are grouped into 3 trial groups
Group A: P01 - General Exposure Cohort
Group B: P02 - Omics Synergistic Subgroup
Group C: S01 - Allergen-Specific Immune Response Subgroup

Trial outcomes

Primary outcomes

1

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.

Time frame
Retrospective data collected over a 3-year period prior to study enrollment.
2

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.

Time frame
Samples collected prospectively between months 10 and 15 (October-March, out-of-pollen season).

Secondary outcomes

1

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.

Time frame
Sample collection and analysis performed prospectively between months 10 and 24.
2

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.

Time frame
Assays conducted on samples collected between months 10 and 24.
3

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

Time frame
Analysis performed between months 10 and 24, post-sample collection.

Other outcomes

Locations

This trial has no 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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