Allergic RhinitisClimAIrNCT07107009
ClimAIr: AI to Assess the Impact of Pollution and Climate on Respiratory Health in Europe
An observational study of Allergic Rhinitis and Asthma, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Allergic Rhinitis, Asthma
- How many people
- 1,906 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Dec 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Climate Change and Air Contamination: Artificial Intelligence Applied on the Correlation Between Air Pollutants and Non-communicable Respiratory Diseases in Europe (ClimAIr)
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.
- Conditions
- Allergic Rhinitis, Asthma
- Keywords
- Air contamination, Air pollutants, Non-communicable respiratory diseases, Climate change, ClimAIr
- Medical subject headings
- Rhinitis, Allergic, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| P01 - General Exposure Cohort | >200 AR patients per environmental condition. Includes patients exposed to various air pollutants, aiming to detect deleterious clinical effects. | |
| P02 - Omics Synergistic Subgroup | 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 | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Retrospective data collected over a 3-year period prior to study enrollment.
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.
Measured: Samples collected prospectively between months 10 and 15 (October-March, out-of-pollen season).
Secondary outcomes (3)
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.
Measured: Sample collection and analysis performed prospectively between months 10 and 24.
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.
Measured: Assays conducted on samples collected between months 10 and 24.
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
Measured: Analysis performed between months 10 and 24, post-sample collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study startJan 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 1,906 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Theramed Healthcare SRL (Romania), Centre Hospitalier Universitaire de Toulouse, FRANCE, Charite-Universitaetsmedizin Berlin (Germany), Aristotelio Panepistimio Thessalonikis (Greece), Uniwersytet Medyczny w Lodzi (Poland), Universita degli Studi di Milano (Italy), Bukovinian State Medical University (Ukraine), Luxembourg Institute of Health, Andaluz Health Service
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107009
- Sponsor's protocol ID
- 101156799-2 ClimAIr
- Acronym
- ClimAIr
- Status last verified
- Dec 2025
- First submitted
- 30 Jul 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Climate Change and Air Contamination: Artificial Intelligence Applied on the Correlation Between Air Pollutants and Non-communicable Respiratory Diseases in Europe (ClimAIr)
- ClinicalTrials.gov ID
- NCT07107009
- Acronym / sponsor ID
- ClimAIr / 101156799-2 ClimAIr
- Conditions
- Allergic Rhinitis, Asthma
- Keywords
- Air contamination, Air pollutants, Non-communicable respiratory diseases, Climate change, ClimAIr
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,906 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Collaborators
- Theramed Healthcare SRL (Romania), Centre Hospitalier Universitaire de Toulouse, FRANCE, Charite-Universitaetsmedizin Berlin (Germany), Aristotelio Panepistimio Thessalonikis (Greece), Uniwersytet Medyczny w Lodzi (Poland), Universita degli Studi di Milano (Italy), Bukovinian State Medical University (Ukraine), Luxembourg Institute of Health, Andaluz Health Service
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| P01 - General Exposure Cohort | – | –>200 AR patients per environmental condition. Includes patients exposed to various air pollutants, aiming to detect deleterious clinical effects. |
| P02 - Omics Synergistic Subgroup | – | –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 | – | –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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinitis and Asthma, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ibon Eguiluz Gracia, MD, PhD (+34 951 291 073, iboneguiluz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Symptom Score of Allergic Rhinitis Patients by Environmental Exposure (time frame: Retrospective data collected over a 3-year period prior to study enrollment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.