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

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

Status: Not yet enrolling

Conditions: Asthma; Allergic Rhinitis

Study type: Observational

Funder types: Other

Identifiers

NCT07107009

101156799-2 ClimAIr

Details and patient eligibility

About

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.

Enrollment: 1,906 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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).
2. 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.
3. 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.
4. 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.

Trial design

1,906 participants in 3 patient groups

P01 - General Exposure Cohort

Description:

\>200 AR patients per environmental condition. Includes patients exposed to various air pollutants, aiming to detect deleterious clinical effects.

P02 - Omics Synergistic Subgroup

Description:

Subgroup of 20 patients per environmental condition from P01. Selected based on exposure to multiple pollutants with observed synergistic effects on omics parameters.

S01 - Allergen-Specific Immune Response Subgroup

Description:

Subgroup of 25 patients per pollution condition from P01. Selected for in vitro assays to evaluate proliferation of peripheral allergen-specific lymphocytes in response to polluted pollen exposure.