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NCT Number: NCT07107009

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

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.

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Key information

Conditions

Allergic Rhinitis Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

Lack of reliable information in e-health records, allergen immunotherapy (any allergen) during the previous 5 years, systemic immunosuppressants or biologicals in the previous six months, chronic rhinosinusitis, and severe systemic conditions.

Treatment and study plan

Primary outcomes

  1. Mean Symptom Score of Allergic Rhinitis Patients by Environmental Exposure

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

    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.

  2. Proteomic Biomarker Levels (NPX) by Environmental Exposure

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

    Proteomic profiles measured using Olink® assays in serum and nasal lavage of allergic rhinitis patients, stratified by environmental exposure.

Secondary outcomes

  1. SO1: Effect of air pollution on adaptive immune responses to allergenic pollen

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

    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.

  2. SO1: Proliferative responses of allergen-specific lymphocytes to pollen exposed to pollution

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

    Measurement of lymphocyte proliferation using CFSE-labeled PBMCs incubated with pollen (Olea europaea, Phleum pratense, Betula pendula) grown under different pollution conditions.

  3. SO1: Cytokine release from allergen-specific lymphocytes in response to polluted pollen

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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Ibon Eguiluz Gracia, MD, PhD

CONTACT

[email protected]

+34 951 291 073

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Other

Collaborators

  • Andaluz Health Service
  • Aristotelio Panepistimio Thessalonikis (Greece)
  • Bukovinian State Medical University (Ukraine)
  • Centre Hospitalier Universitaire de Toulouse, FRANCE
  • Charite-Universitaetsmedizin Berlin (Germany)
  • Luxembourg Institute of Health
  • Theramed Healthcare SRL (Romania)
  • Universita degli Studi di Milano (Italy)
  • Uniwersytet Medyczny w Lodzi (Poland)

Registry information

Official study title

Climate Change and Air Contamination: Artificial Intelligence Applied on the Correlation Between Air Pollutants and Non-communicable Respiratory Diseases in Europe (ClimAIr)

Acronym: ClimAIr

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 6, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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