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New asthma drug may change how patients react to aspirin

NCT ID NCT05031455

Knowledge-focused Sponsor: Scripps Clinic Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how dupilumab, a drug for asthma and nasal polyps, affects reactions to aspirin in people with AERD (a severe form of asthma with sinus issues). 16 adults who were already taking dupilumab for at least 12 weeks took part. Researchers measured breathing, nasal airflow, and symptoms during an aspirin challenge to see if dupilumab changes the reaction.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

16 people

The number who actually took part.

Started

Mar 2024

Finished

Apr 2026

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.

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: * Subjects \>18 years old with Aspirin-Exacerbated Respiratory Disease This is diagnosed via either a positive oral aspirin or intranasal ketorolac challenge OR a history of at least two stereotypical hypersensitivity reactions to aspirin leading to nasal-ocular symptom and/or asthmatic symptoms. * Current treatment with dupilumab at standard asthma/nasal polyposis dosing of 300mg subcutaneously every 2 weeks for a minimum of 12 weeks. * All subjects will be required to have a known history of nasal polyposis either via imaging, endoscopy, or nasal examination Exclusion Criteria: * History of gastrointestinal reactions (severe abdominal pain with or without vomiting) during NSAID triggered events * Unstable asthma or history of severe reactions during previous desensitization attempts * inability to take montelukast pretreatment * history of gastrointestinal bleeding or bleeding disorder * pregnancy * previous use of any other respiratory biologic in the past 3 months (omalizumab, tezepelumab, mepolizumab, reslizumab, benralizumab) * need for systemic corticosteroids to stabilize asthma prior to challenge * time from sinus surgery \<1 month.

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Conditions

The condition(s) this trial relates to.

aspirin-induced respiratory disease asthma, nasal polyps, and aspirin intolerance

As listed by the trial registrant

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

Aspirin-exacerbated respiratory disease

Contacts and locations

Locations

  • Scripps Clini

    San Diego, California, 92130, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.