Severe AsthmaDUPITEOLENCT07721376
Multi-omics in Severe Asthma From Olive Pollen Allergy
An observational study of Severe Asthma and Allergy and Asthma, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Asthma, Allergy and Asthma, Pollen; Allergy, Asthma
- How many people
- 18 participants
- Where
- 1 siteSpain
- Study dates
- 28 Oct 2024to 30 Nov 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: study with prospective follow-up medication , aimed at analyzing the inflammatory status of a group of asthmatic patients allergic to olive pollen with a severe phenotype during treatment with immunotherapy under routine clinical practice conditions and following the technical data sheet, in a group of patients who have previously received a short cycle of dupilumab and another group who have not received this treatment. The initiation and maintenance phase of immunotherapy is administered in our Immunotherapy Unit.
Who may be able to join
- 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).
Who cannot join
- Having received allergen immunotherapy or biological treatment in the last 5 years.
- Pregnant women.
- Relevant comorbidity: cancer, myocardial infarction, severe immunological disorder .
- Contraindications contained in the official technical data sheet for Dupixent® (dupilumab).
- Contraindications of SCIT.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-omics Study (Biological Therapy Followed by Immunotherapy) in Patients With Severe Asthma Due to Olive Pollen Allergy
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.
Read more
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.
Read the detailed description
Olive pollen (Olea europaea) is one of the leading causes of respiratory allergy in Mediterranean countries. Among the 14 olive pollen allergens identified to date, Ole e 1 is the major sensitizing allergen, whereas sensitization to Ole e 7 is strongly associated with a severe clinical phenotype in regions with intense olive cultivation, such as Córdoba (Spain). This phenotype is characterized by persistent airway inflammation, poor asthma control, and reduced response to allergen immunotherapy despite standard treatment.
Previous studies have demonstrated that severe olive pollen allergy is associated with a predominant type 2 inflammatory response, including increased frequencies of Th2 cells and type 2 innate lymphoid cells (ILC2), together with an imbalance between Th2 and Th1 immune responses. These immunological alterations are considered major contributors to persistent airway inflammation and reduced clinical efficacy of allergen immunotherapy.
Dupilumab, a fully human monoclonal antibody targeting the interleukin-4 receptor alpha (IL-4Rα), inhibits signaling mediated by both IL-4 and IL-13 and has demonstrated efficacy in several type 2 inflammatory diseases, including severe asthma, chronic rhinosinusitis with nasal polyps, and atopic dermatitis. Short-term treatment with biological agents has also been shown to restore immune homeostasis and improve subsequent responses to allergen immunotherapy in selected allergic populations.
This observational study is conducted within the framework of the ISCIII-funded competitive research project PI22/01737. The objective is to characterize longitudinal immunological and molecular changes associated with allergen immunotherapy in severe olive pollen-induced allergic asthma and to evaluate the influence of previous short-term dupilumab treatment on these responses under routine clinical practice conditions.
Clinical follow-up will be complemented by comprehensive multi-omics analyses, including targeted serum metabolomics, serum proteomics, transcriptomic profiling, and peripheral T-cell immunophenotyping. These complementary approaches are intended to identify biological pathways associated with immune regulation, inflammatory activity, and the development of long-term immune tolerance during allergen immunotherapy.
Comparisons will be performed between individuals previously treated with a short course of dupilumab before initiation of allergen immunotherapy and individuals receiving conventional treatment without previous biological therapy. The integration of clinical, immunological, and multi-omics data is expected to improve the understanding of mechanisms associated with successful allergen immunotherapy and to identify candidate biomarkers related to treatment response and immune stabilization.
Because of the exploratory nature of the study and the complexity of the molecular analyses, the findings will primarily generate biological hypotheses and candidate biomarkers for validation in larger prospective cohorts. Identification of reproducible molecular signatures associated with successful immune modulation may contribute to the development of more personalized therapeutic strategies for severe olive pollen allergy and optimize the use of allergen immunotherapy in this population.
- Conditions
- Severe Asthma, Allergy and Asthma, Pollen; Allergy, Asthma
- Keywords
- Severe asthma, Dupilumab, olive pollen allergy, immunotherapy
- Medical subject headings
- Asthma, Hypersensitivity
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 |
|---|---|---|
| Dupilumab Pre-treated | Severe Phenotype Olive Pollen Allergy Patients Treated with Conventional Therapy plus Dupilumab | |
| Conventional Treated | Severe Phenotype Olive Pollen Allergy Patients Treated with Conventional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Targeted serum metabolomic profile
A targeted serum metabolomic profile associated with allergic inflammation will be assessed using a validated targeted metabolomics platform to evaluate changes induced by allergen immunotherapy.
Measured: Baseline T0 (March 2024) and annually during the 3-year allergen immunotherapy period T1 (October 2024), T2, and T3, with additional assessments at 1 and 2 years after treatment completion (T4 and T5).
Serum proteomic profile
Serum levels of proteins involved in allergic inflammation and immune regulation will be quantified to evaluate changes during allergen immunotherapy. Protein quantification will be performed using a validated proximity extension assay (PEA).
Measured: Baseline (T0), T1 (October 2024), annually during the 3-year allergen immunotherapy (T2-T3), and 1 and 2 years after treatment completion (T4-T5).
Transcriptomic profile
Gene expression profiles associated with allergic inflammation and immune regulation will be assessed by RNA sequencing to evaluate changes during allergen immunotherapy.
Measured: Baseline (T0), T1 (October 2024), annually during the 3-year allergen immunotherapy (T2-T3), and 1 and 2 years after treatment completion (T4-T5).
Asthma Control Test (ACT) score
Asthma control will be assessed using the validated Asthma Control Test (ACT). Changes in ACT score during allergen immunotherapy will be evaluated.
Measured: Every 4 weeks during the first 6 months (T0), annually during each olive pollen season the 3-year immunotherapy period (T1-T3), and at 1 and 2 years post-treatment (T4-T5).
Asthma symptom and medication score
Asthma symptoms and rescue medication use will be assessed using the predefined study score during each olive pollen season.
Measured: Every 2 weeks during olive pollen season at T0, annually during each olive pollen (5 assessments) season the 3-year immunotherapy period (T1-T3), and at 1 and 2 years post-treatment (T4-T5).
Peripheral T-cell immunophenotype
Peripheral effector and regulatory T-cell subsets will be quantified by multiparametric flow cytometry to evaluate immunological changes during allergen immunotherapy.
Measured: Baseline (T0), T1 (October 2024), annually during the 3-year allergen immunotherapy (T2-T3), and 1 and 2 years after treatment completion (T4-T5).
Secondary outcomes (7)
Baseline demographic characteristics
Baseline demographic characteristics, including age and sex, will be collected.
Measured: Baseline (T0)
Body mass index (BMI)
Body mass index (BMI) will be calculated from height and weight recorded during follow-up. Weight and height will be combined to report BMI in kg/m^2.
Measured: Baseline (T0) and annually at T1-T5.
Asthma control according to GEMA
Asthma control will be classified as controlled, partially controlled, or uncontrolled according to the GEMA guideline.
Measured: Every 2 weeks during olive pollen season at T0, annually during each olive pollen (5 assessments) season the 3-year immunotherapy period (T1-T3), and at 1 and 2 years post-treatment (T4-T5).
Asthma treatment step according to GEMA
Asthma treatment will be classified according to the GEMA treatment step required to maintain disease control.
Measured: Every 2 weeks during olive pollen season at T0, annually during each olive pollen (5 assessments) season the 3-year immunotherapy period (T1-T3), and at 1 and 2 years post-treatment (T4-T5).
Rhinoconjunctivitis symptom and medication score
Rhinoconjunctivitis symptoms and rescue medication use will be assessed using a predefined study score during each olive pollen season.
Measured: Every 2 weeks during olive pollen season at T0, annually during each olive pollen (5 assessments) season the 3-year immunotherapy period (T1-T3), and at 1 and 2 years post-treatment (T4-T5).
Forced expiratory volume in one second (FEV1)
Forced expiratory volume in one second (FEV1) will be assessed by spirometry according to ATS/ERS recommendations.
Measured: Every 2 weeks during olive pollen season at T0, annually during each olive pollen (5 assessments) season the 3-year immunotherapy period (T1-T3), and at 1 and 2 years post-treatment (T4-T5).
Mini Asthma Quality of Life Questionnaire (MiniAQLQ) score
Health-related quality of life will be assessed using the Mini Asthma Quality of Life Questionnaire (MiniAQLQ). Scores range from 1 to 7, with higher scores indicating better quality of life.
Measured: Every 2 weeks during olive pollen season at T0, annually during each olive pollen (5 assessments) season the 3-year immunotherapy period (T1-T3), and at 1 and 2 years post-treatment (T4-T5).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start28 Oct 2024
- Primary completion30 Nov 2029 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe AsthmaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Collaborators
- CEU San Pablo University
- Responsible party
- Sponsor
- Investigators
- Berta Ruiz-Leon, MD., Ph.D., Principal investigator, Hospital Universitario Reina Sofia de Cordoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07721376
- Sponsor's protocol ID
- FCO-DPT-2024-01
- Acronym
- DUPITEOLE
- Status last verified
- Jul 2026
- First submitted
- 30 Dec 2024
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Escribese MM, Gomez-Casado C, Barber D, Diaz-Perales A. Immune Polarization in Allergic Patients: Role of the Innate Immune System. J Investig Allergol Clin Immunol. 2015;25(4):251-8.
PubMed 26310039
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-omics Study (Biological Therapy Followed by Immunotherapy) in Patients With Severe Asthma Due to Olive Pollen Allergy
- ClinicalTrials.gov ID
- NCT07721376
- Acronym / sponsor ID
- DUPITEOLE / FCO-DPT-2024-01
- Conditions
- Severe Asthma, Allergy and Asthma, Pollen; Allergy, Asthma
- Keywords
- Severe asthma, Dupilumab, olive pollen allergy, immunotherapy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Collaborators
- CEU San Pablo University
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- 30 Nov 2029 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 23 Jul 2026 (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.
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.
Detailed description
Olive pollen (Olea europaea) is one of the leading causes of respiratory allergy in Mediterranean countries. Among the 14 olive pollen allergens identified to date, Ole e 1 is the major sensitizing allergen, whereas sensitization to Ole e 7 is strongly associated with a severe clinical phenotype in regions with intense olive cultivation, such as Córdoba (Spain). This phenotype is characterized by persistent airway inflammation, poor asthma control, and reduced response to allergen immunotherapy despite standard treatment.
Previous studies have demonstrated that severe olive pollen allergy is associated with a predominant type 2 inflammatory response, including increased frequencies of Th2 cells and type 2 innate lymphoid cells (ILC2), together with an imbalance between Th2 and Th1 immune responses. These immunological alterations are considered major contributors to persistent airway inflammation and reduced clinical efficacy of allergen immunotherapy.
Dupilumab, a fully human monoclonal antibody targeting the interleukin-4 receptor alpha (IL-4Rα), inhibits signaling mediated by both IL-4 and IL-13 and has demonstrated efficacy in several type 2 inflammatory diseases, including severe asthma, chronic rhinosinusitis with nasal polyps, and atopic dermatitis. Short-term treatment with biological agents has also been shown to restore immune homeostasis and improve subsequent responses to allergen immunotherapy in selected allergic populations.
This observational study is conducted within the framework of the ISCIII-funded competitive research project PI22/01737. The objective is to characterize longitudinal immunological and molecular changes associated with allergen immunotherapy in severe olive pollen-induced allergic asthma and to evaluate the influence of previous short-term dupilumab treatment on these responses under routine clinical practice conditions.
Clinical follow-up will be complemented by comprehensive multi-omics analyses, including targeted serum metabolomics, serum proteomics, transcriptomic profiling, and peripheral T-cell immunophenotyping. These complementary approaches are intended to identify biological pathways associated with immune regulation, inflammatory activity, and the development of long-term immune tolerance during allergen immunotherapy.
Comparisons will be performed between individuals previously treated with a short course of dupilumab before initiation of allergen immunotherapy and individuals receiving conventional treatment without previous biological therapy. The integration of clinical, immunological, and multi-omics data is expected to improve the understanding of mechanisms associated with successful allergen immunotherapy and to identify candidate biomarkers related to treatment response and immune stabilization.
Because of the exploratory nature of the study and the complexity of the molecular analyses, the findings will primarily generate biological hypotheses and candidate biomarkers for validation in larger prospective cohorts. Identification of reproducible molecular signatures associated with successful immune modulation may contribute to the development of more personalized therapeutic strategies for severe olive pollen allergy and optimize the use of allergen immunotherapy in this population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dupilumab Pre-treated | – | –Severe Phenotype Olive Pollen Allergy Patients Treated with Conventional Therapy plus Dupilumab |
| Conventional Treated | – | –Severe Phenotype Olive Pollen Allergy Patients Treated with Conventional Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- study with prospective follow-up medication , aimed at analyzing the inflammatory status of a group of asthmatic patients allergic to olive pollen with a severe phenotype during treatment with immunotherapy under routine clinical practice conditions and following the technical data sheet, in a group of patients who have previously received a short cycle of dupilumab and another group who have not received this treatment. The initiation and maintenance phase of immunotherapy is administered in our Immunotherapy Unit.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- Having received allergen immunotherapy or biological treatment in the last 5 years.
- Pregnant women.
- Relevant comorbidity: cancer, myocardial infarction, severe immunological disorder .
- Contraindications contained in the official technical data sheet for Dupixent® (dupilumab).
- Contraindications of SCIT.
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
Targeted serum metabolomic profile
Time frame: Baseline T0 (March 2024) and annually during the 3-year allergen immunotherapy period T1 (October 2024), T2, and T3, with additional assessments at 1 and 2 years after treatment completion (T4 and T5).
A targeted serum metabolomic profile associated with allergic inflammation will be assessed using a validated targeted metabolomics platform to evaluate changes induced by allergen immunotherapy.
Serum proteomic profile
Time frame: Baseline (T0), T1 (October 2024), annually during the 3-year allergen immunotherapy (T2-T3), and 1 and 2 years after treatment completion (T4-T5).
Serum levels of proteins involved in allergic inflammation and immune regulation will be quantified to evaluate changes during allergen immunotherapy. Protein quantification will be performed using a validated proximity extension assay (PEA).
Transcriptomic profile
Time frame: Baseline (T0), T1 (October 2024), annually during the 3-year allergen immunotherapy (T2-T3), and 1 and 2 years after treatment completion (T4-T5).
Gene expression profiles associated with allergic inflammation and immune regulation will be assessed by RNA sequencing to evaluate changes during allergen immunotherapy.
Asthma Control Test (ACT) score
Time frame: Every 4 weeks during the first 6 months (T0), annually during each olive pollen season the 3-year immunotherapy period (T1-T3), and at 1 and 2 years post-treatment (T4-T5).
Asthma control will be assessed using the validated Asthma Control Test (ACT). Changes in ACT score during allergen immunotherapy will be evaluated.
Asthma symptom and medication score
Time frame: Every 2 weeks during olive pollen season at T0, annually during each olive pollen (5 assessments) season the 3-year immunotherapy period (T1-T3), and at 1 and 2 years post-treatment (T4-T5).
Asthma symptoms and rescue medication use will be assessed using the predefined study score during each olive pollen season.
Peripheral T-cell immunophenotype
Time frame: Baseline (T0), T1 (October 2024), annually during the 3-year allergen immunotherapy (T2-T3), and 1 and 2 years after treatment completion (T4-T5).
Peripheral effector and regulatory T-cell subsets will be quantified by multiparametric flow cytometry to evaluate immunological changes during allergen immunotherapy.
7 secondary outcomes
Baseline demographic characteristics
Time frame: Baseline (T0)
Body mass index (BMI)
Time frame: Baseline (T0) and annually at T1-T5.
Asthma control according to GEMA
Time frame: Every 2 weeks during olive pollen season at T0, annually during each olive pollen (5 assessments) season the 3-year immunotherapy period (T1-T3), and at 1 and 2 years post-treatment (T4-T5).
Asthma treatment step according to GEMA
Time frame: Every 2 weeks during olive pollen season at T0, annually during each olive pollen (5 assessments) season the 3-year immunotherapy period (T1-T3), and at 1 and 2 years post-treatment (T4-T5).
Rhinoconjunctivitis symptom and medication score
Time frame: Every 2 weeks during olive pollen season at T0, annually during each olive pollen (5 assessments) season the 3-year immunotherapy period (T1-T3), and at 1 and 2 years post-treatment (T4-T5).
Forced expiratory volume in one second (FEV1)
Time frame: Every 2 weeks during olive pollen season at T0, annually during each olive pollen (5 assessments) season the 3-year immunotherapy period (T1-T3), and at 1 and 2 years post-treatment (T4-T5).
Mini Asthma Quality of Life Questionnaire (MiniAQLQ) score
Time frame: Every 2 weeks during olive pollen season at T0, annually during each olive pollen (5 assessments) season the 3-year immunotherapy period (T1-T3), and at 1 and 2 years post-treatment (T4-T5).
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 23 Jul 2026.
- Background: PubMed 26310039Escribese MM, Gomez-Casado C, Barber D, Diaz-Perales A. Immune Polarization in Allergic Patients: Role of the Innate Immune System. J Investig Allergol Clin Immunol. 2015;25(4):251-8.
- 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. This study is not recruiting at the moment.
Berta Ruiz-Leon, MD., Ph.D. principal investigator
Hospital Universitario Reina Sofia de Cordoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Asthma and Allergy and Asthma, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Targeted serum metabolomic profile (time frame: Baseline T0 (March 2024) and annually during the 3-year allergen immunotherapy period T1 (October 2024), T2, and T3, with additional assessments at 1 and 2 years after treatment completion (T4 and T5).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07721376, which also lists 1 linked publication.
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 23 Jul 2026.