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Can nasal sprays replace antibiotics for sinus infections? major study aims to find out

NCT ID NCT06076304

Symptom relief Sponsor: Daniel Merenstein Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether antibiotics, nasal steroids, or nasal irrigation work best for treating sinus infections. About 3,720 adults with acute sinusitis will be randomly assigned to one of these treatments or a placebo. The goal is to see which approach provides the most symptom relief and to help reduce unnecessary antibiotic use.

What this could mean

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

Active substance
amoxicillin/clavulanate (Augmentin) and budesonide nasal spray (Rhinocort)
What this could lead to
If successful, this could help doctors know which sinus infection patients truly need antibiotics and which can be treated with nasal sprays or rinses instead.
What could go wrong
This is a large but still early-phase study. Results may not apply to everyone, and some people may not improve with any of the treatments tested.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 3,720 people

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

Started

Nov 2023

Expected to finish

Dec 2028

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.

Inclusion Criteria: 1. 18-75 years old; AND are experiencing either: 2. "persistent" symptoms or signs compatible with ARS or sinus infection lasting for 1-21 days without any evidence of clinical improvement (Symptoms include facial pain or pressure, facial congestion or fullness, nasal obstruction, nasal discharge, no or reduced sense of smell, fever ≤39°C or 102°F, headache, bad smelling breath, fatigue, ear pain or pressure, and dental pain); OR 3. onset with worsening symptoms or signs characterized by the new onset of fever, headache, or increase in nasal discharge following a typical viral upper respiratory infection (URI) that lasted 5-6 days and were initially improving (''double-sickening''). Exclusion Criteria: * allergy or intolerance to penicillin * received systemic antibiotic therapy in the past 4 weeks * prior sinus surgery (cosmetic surgery, such as rhinoplasty, septal deviation, etc. are not exclusionary) * complications of sinusitis (facial edema (swelling), cellulitis), or orbital, meningeal or cerebral signs) * health care clinician determined IV (intravenous) antibiotics or hospital admission are required * pregnancy or breastfeeding * presence of a comorbidity or medication that may impair a patient's immune response as determined by a health care clinician * hospitalization in past 5 days * unable or unwilling to provide informed consent or comply with study protocol requirements * fever \>39°C or 102°F today * taking intranasal corticosteroids (INCS) regularly in the past two weeks and unwilling to stop its use while in the study; OR * previously enrolled or participated in the feasibility phase or this stage of study

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Conditions

The condition(s) this trial relates to.

sinusitis

As listed by the trial registrant

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

Acute sinusitis Sinus infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    7 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Georgetown University Medical Center

    RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • MedStar Health Research Institute

    NOT_YET_RECRUITING

    Hyattsville, Maryland, 20782, United States

  • Penn State College of Medicine

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • University of California, Los Angeles

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of Washington

    RECRUITING

    Seattle, Washington, 98195, United States

  • University of Wisconsin-Madison

    RECRUITING

    Madison, Wisconsin, 53705, United States

  • Virginia Commonwealth University

    RECRUITING

    Richmond, Virginia, 23219, United States

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