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Multi-omics in Severe Asthma From Olive Pollen Allergy

NCT07721376 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2026-07-23

No results posted yet for this study

Summary

Patients with severe olive pollen allergy exhibit characteristic sensitization profiles, marked by strong recognition of minor allergens like Ole e 7, and, more importantly, show poor clinical responses to pharmacological treatments and immunotherapy. Previous studies have revealed that these patients experience a permanent immunological dysfunction (notably, dysregulated effector T-cell function) leading to a systemic inflammatory state that persists beyond the pollen season.

The hypothesis is that short-term treatment (6 months) with Dupilumab can stabilize and reverse the inflammatory state in patients with severe olive pollen allergy (Project PI22/01737), enabling them to transition to conventional allergen immunotherapy.

This study aims to deepen our understanding of the mechanisms underlying this immunological stabilization through multi-omics profiling (metabolomics, proteomics, transcriptomics) to explain the resolution of inflammation. Specifically, the goal is to restore an effective regulatory T-cell response, allowing for allergen-specific immunotherapy, which can be administered for three years in routine clinical practice as the only treatment capable of altering the disease's progression.

Since immunotherapy relies on functional regulatory T-cell responses, this approach could validate a therapeutic strategy for these patients that modifies the disease long-term, breaking the cycle of chronic inflammation. This would reduce dependency on costly biologic treatments and significantly improve the quality of life.

Conditions

Sponsors & Collaborators

  • CEU San Pablo University

    collaborator OTHER

  • Maimónides Biomedical Research Institute of Córdoba

    lead OTHER

Principal Investigators

  • Berta Ruiz-Leon, MD., Ph.D. · Hospital Universitario Reina Sofia de Cordoba

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-28
Primary Completion
2029-11-30
Completion
2029-11-30

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07721376 on ClinicalTrials.gov