Chronic Rhinosinusitis Trial, Completed (NCT00465530)

Chronic Rhinosinusitis Trial, Completed NCT00465530 Sponsor: Julie Wei, MD Condition: Chronic Rhinosinusitis

Printed from Voxsanity (voxsanity.com.au) — NCT00465530 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Chronic Rhinosinusitis

Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial involved 40 people in total — 21 were assigned to rinse their sinuses once daily with a saline (salt water) solution containing an antibiotic called gentamicin, while 19 used a plain saline rinse without any antibiotic. Each group rinsed with 40 mL into each nostril. The trial was measuring two main things: changes in sinus appearance on a CT scan (a type of detailed X-ray), and changes in overall quality of life related to sinus symptoms. The reported data shows that both groups had small reductions in their CT scan scores over the course of the trial. CT scores were measured using a system where a lower score means less blockage in the sinuses — a score of 0 means no blockage, and a score of 2 means the sinus is completely blocked. The reported changes in CT scores across different sinus areas ranged from around −0.50 to −1.06 for the gentamicin-plus-saline group, and from around −0.50 to −0.79 for the saline-only group, meaning both groups showed some reduction in measured blockage. For quality of life, participants rated their symptoms on a scale from 0 to 7, where a higher number means a worse problem. The reported data shows the saline-only group had a change of 0.69 and the gentamicin-plus-saline group had a change of 1.38, suggesting both groups reported some improvement in quality of life scores during the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View full results on ClinicalTrials.gov ↗

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

The child must be between 4 and 17 years old and generally healthy
The child must have a history of recurring or long-lasting sinus problems
The child must have had more than 3 months of symptoms such as a stuffy nose, nasal discharge, persistent daytime cough, mucus dripping down the throat, headaches, facial pain, bad breath, or occasional fevers
The child's parent or guardian must be able to read and understand English
The child must have received at least 3 courses of antibiotic pills, or at least 21 total days of antibiotic pills, for these sinus symptoms in the past 3 months
The child must have had a specific type of sinus scan (a CT scan without dye) within the past two months that shows blockage in one or more sinuses

Who may not be able to join:

The parent or guardian is not able to read and understand English
The child has an intellectual disability, thinking or learning difficulties, or developmental delays
The child has a history of cystic fibrosis
The child has a condition called immotile cilia syndrome, which affects the tiny hairs in the airways (confirm with trial site)
The child has a weakened immune system or a condition that affects their ability to fight infections
The child had a completely normal sinus scan within the past 4 weeks and has none of the sinus symptoms listed above
The child has previously had sinus surgery using a small camera (endoscopic sinus surgery)
The child has been unable to tolerate nasal rinsing/flushing in the past 6 months
The child has used a nasal rinse containing gentamicin or a saltwater nasal rinse within the past 3 months
The child has nasal polyps (small growths inside the nose)
The child has ever had an allergic reaction to the antibiotic gentamicin or a related group of antibiotics called aminoglycosides

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 28 July 2026

This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

GP referral letter

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Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I found the following past clinical trial relevant to my condition, and wanted to raise it with you. It is no longer recruiting, but I wanted to ask whether similar active trials exist, or whether its results are relevant to my care:

Trial: NCT00465530

Sponsor: Julie Wei, MD

Phase: Not Applicable

Status: Completed

Condition: Chronic Rhinosinusitis

More information: https://clinicaltrials.gov/study/NCT00465530

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

The child must be between 4 and 17 years old and generally healthy
The child must have a history of recurring or long-lasting sinus problems
The child must have had more than 3 months of symptoms such as a stuffy nose, nasal discharge, persistent daytime cough, mucus dripping down the throat, headaches, facial pain, bad breath, or occasional fevers
The child's parent or guardian must be able to read and understand English
The child must have received at least 3 courses of antibiotic pills, or at least 21 total days of antibiotic pills, for these sinus symptoms in the past 3 months
The child must have had a specific type of sinus scan (a CT scan without dye) within the past two months that shows blockage in one or more sinuses

Who may not be able to join:

The parent or guardian is not able to read and understand English
The child has an intellectual disability, thinking or learning difficulties, or developmental delays
The child has a history of cystic fibrosis
The child has a condition called immotile cilia syndrome, which affects the tiny hairs in the airways (confirm with trial site)
The child has a weakened immune system or a condition that affects their ability to fight infections
The child had a completely normal sinus scan within the past 4 weeks and has none of the sinus symptoms listed above
The child has previously had sinus surgery using a small camera (endoscopic sinus surgery)
The child has been unable to tolerate nasal rinsing/flushing in the past 6 months
The child has used a nasal rinse containing gentamicin or a saltwater nasal rinse within the past 3 months
The child has nasal polyps (small growths inside the nose)
The child has ever had an allergic reaction to the antibiotic gentamicin or a related group of antibiotics called aminoglycosides

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 28 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Completed

Phase

Not Applicable

Sponsor

Julie Wei, MD

Registry

ClinicalTrials.gov

Start date

1 March 2007

Est. completion

1 March 2010

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Computed Tomography (CT) Score After Treatment; Change in Overall Quality of Life

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov