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Not yet recruitingNCT07107009ClimAIrUpdated Dec 17, 2025

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

An observational study in Allergic Rhinitis and Asthma, sponsored by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud. Not yet recruiting. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2025-12-17.

Sponsored by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 5 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
1,906
Ages
12 Years and older
Sex
All
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Study 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. 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.

02

Conditions studied

  • Allergic Rhinitis
  • Asthma

Keywords

  • Air contamination
  • Air pollutants
  • Non-communicable respiratory diseases
  • Climate change
  • ClimAIr
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In context

Rhinitis, Allergic

717 studies on the registry are indexed under Rhinitis, Allergic; 94 are open to participants now.

This study's planned enrollment of 1,906 is above the median of 120 across 143 observational studies indexed under Rhinitis, Allergic.

Browse Rhinitis, Allergic studies →

Lead sponsor

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud is the lead sponsor of 71 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

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Study design

Observational model
Other
Time perspective
Other
Enrollment
1,906 participants (estimated)
Target follow-up
3 Months
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

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What researchers measure

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.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2026; primary completion for Jun 2026, 5 months later.

Of 36 non-industry observational studies under Rhinitis, Allergic, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 37. This study's planned 5 months is below that.

Counting every sponsor, half of 49 studies reached it within 21 months; a quarter within 12 and three quarters within 29.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 30, 2025
First posted
Aug 6, 2025
StartEst.
Jan 2026
Primary completionEst.
Jun 2026
CompletionEst.
Dec 2027
Last update
Dec 17, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07107009
Lead sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
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
First posted
Aug 6, 2025
Start date
Jan 2026 (estimated)
Primary completion
Jun 2026 (estimated)
Completion
Dec 2027 (estimated)
Last update
Dec 17, 2025

Study contacts

Ibon Eguiluz Gracia, MD, PhD
Contact
iboneguiluz@gmail.com
+34 951 291 073

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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