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Triple-Action nasal spray could ease chronic sinusitis

NCT ID NCT07635433

Disease control Sponsor: The First Affiliated Hospital of Xinxiang Medical College 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-stage trial tests a nasal spray for adults with chronic sinusitis (without polyps). The spray contains stem cell exosomes to heal the nose lining, an antibiotic to kill bacteria, and an enzyme to break up thick mucus. 108 participants will use the spray twice daily for 4 weeks to check safety and see if it improves symptoms.

What this could mean

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

Active substance
A nasal spray containing stem cell exosomes, an antibiotic (mupirocin), and an enzyme (DNase I) in a gel that turns solid inside the nose
What this could lead to
If it works, this could offer a new non-surgical option for people with chronic sinusitis, reducing infections and improving quality of life.
What could go wrong
This is an early phase 1 trial with only 108 people, so safety and effectiveness are not yet proven. The spray may cause side effects like nose irritation or allergic reactions.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 108 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

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 65 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: * Age 18 to 65 years, both genders * Diagnosis of chronic rhinosinusitis without nasal polyps according to Chinese guidelines (2018), duration \>12 weeks * Nasal endoscopy shows purulent secretions (Lund-Kennedy secretion score ≥1) * Nasal secretion culture positive for Staphylococcus aureus * Sino-Nasal Outcome Test-22 (SNOT-22) score ≥30 * Voluntary signed informed consent Exclusion Criteria: * Sinus surgery within past 6 months, or anatomical abnormalities requiring reoperation * Confirmed allergic fungal rhinosinusitis, odontogenic rhinosinusitis, or nasal polyps * Nasal discharge culture indicating Pseudomonas aeruginosa as primary pathogen * Primary ciliary dyskinesia, cystic fibrosis, or severe immunodeficiency * Use of systemic antibiotics or immunosuppressants within past 4 weeks * Use of intranasal corticosteroids within past 2 weeks * Hypersensitivity to mupirocin, DNase I, or any component of the formulation * Severe renal impairment (estimated Glomerular Filtration Rate, eGFR \<60 mL/min/1.73 m²) * Pregnant, breastfeeding, or planning to become pregnant during the study * Uncontrolled severe systemic diseases (diabetes, hypertension, autoimmune diseases) * Malignancy within past 5 years * Participation in other clinical trials

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Conditions

The condition(s) this trial relates to.

chronic rhinosinusitis staphylococcal infection

As listed by the trial registrant

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

Chronic rhinosinusitis with nasal polyps

How to take part

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

  1. 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 ↗

  2. A doctor treating you

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More trials for these conditions

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