A two-step strategy: biologic drug may pave the way for immunotherapy in severe olive pollen asthma

NCT ID NCT07721376

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This study tests whether a six-month course of dupilumab can calm the immune system enough for patients with severe olive pollen asthma to then benefit from standard allergy immunotherapy. Researchers will use advanced molecular profiling to understand how the treatment restores immune balance. The goal is to find a way to reduce dependence on expensive biologic drugs and improve long-term asthma control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a biologic drug called dupilumab followed by allergen immunotherapy
What this could lead to
If successful, this approach could allow patients with severe olive pollen asthma to switch from costly biologic therapy to long-term immunotherapy, potentially altering the disease course.
What could go wrong
This is a very small early-stage study with only 18 participants. The strategy may not work for all patients, and biologic therapy carries risks like injection reactions and infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 18 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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). Exclusion criteria 1. Having received allergen immunotherapy or biological treatment in the last 5 years. 2. Pregnant women. 3. Relevant comorbidity: cancer, myocardial infarction, severe immunological disorder . 4. Contraindications contained in the official technical data sheet for Dupixent® (dupilumab). 5. Contraindications of SCIT.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Hospital Universitario Reina Sofia

    Córdoba, Cordoba, 14004, Spain

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