Clinical Trial

Multi-omics in Severe Asthma From Olive Pollen Allergy

Study acronym: DUPITEOLE
Active, Not Recruiting
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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.
Trial Details
NCT Number NCT07721376
Lead Sponsor Maimónides Biomedical Research Institute of Córdoba
Collaborators: CEU San Pablo University
Conditions Severe Asthma, Allergy and Asthma, Pollen; Allergy, Asthma
Enrollment 18 participants
Start Date 2024-10-28
Primary Completion 2029-11-30 (estimated)
Study Completion 2029-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-23