NCT07721376Active, not recruiting
Multi-omics in Severe Asthma From Olive Pollen Allergy
Multi-omics Study (Biological Therapy Followed by Immunotherapy) in Patients With Severe Asthma Due to Olive Pollen Allergy
Source: ClinicalTrials.gov · Last updated 23 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 18 (estimated)
- First submitted
- 30 Dec 2024
- Start date
- Oct 2024
- Primary completion date
- Nov 2029
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Diseases
- Asthma
- NCT number
- NCT07721376
What you commit to
- Study type: Observational
- Planned participants: 18
- From Oct 2024 to the primary completion date, Nov 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Having received allergen immunotherapy or biological treatment in the last 5 years.
Other illness
- Relevant comorbidity: cancer, myocardial infarction, severe immunological disorder .
Other
- Pregnant women.
- Contraindications contained in the official technical data sheet for Dupixent® (dupilumab).
- Contraindications of SCIT.
Who the study is looking for
- Patients ≥ 18 years old, residing in areas with high olive pollen exposure (exceeding 10,000 grains/m³ during the past five pollen seasons).
- Proven allergy to olive pollen with predominant or isolated sensitization to Ole e 7.
- Diagnosis of asthma that remains uncontrolled despite completing steps 5-6 of the GEMA guidelines during the olive pollen season.
- Controlled asthma with a forced expiratory volume in 1 second (FEV1) \> 80% of the predicted normal value before starting subcutaneous immunotherapy (SCIT).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.