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Not yet recruiting NCT07107009

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

Observational Allergic Rhinitis Asthma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Allergic Rhinitis, Asthma. Basic parameters: from 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Mean Symptom Score of Allergic Rhinitis Patients by Environmental Exposure [Time frame: Retrospective data collected over a 3-year period prior to study enrollment.]
  • Proteomic Biomarker Levels (NPX) by Environmental Exposure [Time frame: Samples collected prospectively between months 10 and 15 (October-March, out-of-pollen season).]
Secondary outcome measures (3)
  • 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.]
  • SO1: Proliferative responses of allergen-specific lymphocytes to pollen exposed to pollution [Time frame: Assays conducted on samples collected between months 10 and 24.]
  • SO1: Cytokine release from allergen-specific lymphocytes in response to polluted pollen [Time frame: Analysis performed between months 10 and 24, post-sample collection.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07107009 · 101156799-2 ClimAIr

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗