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Can a new drug help people with aspirin allergy, asthma, and nasal polyps?

NCT ID NCT05575037

Disease control Sponsor: Brigham and Women's Hospital 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Aug 14, 2026 · Updated 3 times

Summary

This Phase 2 trial is testing dupilumab (Dupixent) in 17 people with aspirin-exacerbated respiratory disease (AERD), a condition that includes asthma, nasal polyps, and severe reactions to aspirin. The study aims to see if the drug can reduce markers of inflammation and improve sense of smell over 8 weeks. It is designed to understand how the drug works rather than to prove it is a cure.

What this could mean

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

Active substance
Dupilumab (Dupixent)
What this could lead to
If successful, this could point toward a treatment that improves smell and reduces nasal polyp burden in people with AERD.
What could go wrong
This is a very small, early-phase study (17 people) focused on understanding how the drug works, not on proving it is effective. Results may not apply to all patients.

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

17 people

The number who actually took part.

Started

Aug 2023

Expected to finish

Dec 2026

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.

Ages

18 to 75 years

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.

Key Inclusion Criteria: 1. History of AERD, defined as meeting the diagnostic triad with: 1. History of physician-diagnosed asthma and 2. History of physician-diagnosed nasal polyposis and 3. History of pathognomonic reactions to aspirin or other nonselective COX inhibitors. 2. Visible nasal polyps bilaterally on otoscope physical exam at the time of screening. 3. Evidence of sense of smell impairment, with a University of Pennsylvania Smell Identification Test (UPSIT) score of \<34. 4. Stable asthma (no glucocorticoid burst for at least 4 weeks prior to Visit 1, and no hospitalizations or ER visits for asthma for at least the prior 3 months). 5. Consistent (daily) use of an intranasal steroid for at least 4 weeks prior to Screening. 6. No current smoking (not more than one instance of smoking in the last 3 months). 7. For females: Practicing FDA-approved methods of birth control for the duration of the study. Female participants of childbearing potential must have a negative pregnancy test upon study entry. Key Exclusion Criteria: 1. Use of investigational drugs within 12 weeks of Screening. 2. Use of any biologic agent within 4 months prior to Screening. 3. Use of systemic (enteral or injected) glucocorticoids within 4 weeks prior to Screening. 4. History of any sinonasal surgery within 4 months prior to Screening 5. Current use of zileuton 6. Current use of high-dose aspirin therapy (no more than 325 mg aspirin per day will be allowed) 7. Pregnant, nursing, or planning to become pregnant Note: Other inclusion and exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

aspirin-induced respiratory disease asthma Asthma, Aspirin-Induced asthma, nasal polyps, and aspirin intolerance nasal cavity polyp

As listed by the trial registrant

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

Aspirin-exacerbated respiratory disease Aspirin-sensitive asthma with nasal polyps Asthma, aspirin-induced Nasal polyps

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

More trials for these conditions

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