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 (NCT03599271) enrolled a total of 75 people across two groups: 70 participants in a "Randomised Cohort," where each person received both a drug-coated balloon device on one side of their nose and a standard (non-drug-coated) balloon device on the other side; and 5 participants in a smaller "PK Cohort" focused on safety and drug levels. The trial was measuring the openness of the frontal sinus ostia (FSO) — the small opening that connects the frontal sinus to the nasal passage — using a specially sized probe and a scoring system from 0 (completely blocked) to 4 (fully open). The reported data shows that in the Randomised Cohort, the average openness score at Day 30 was 1.6 out of 4 for the side treated with the drug-coated device, and 1.5 out of 4 for the side treated with the standard device. For the estimated size of the opening, the treatment side measured approximately 2.8 mm (largest) and 2.2 mm (smallest), while the control side measured approximately 2.6 mm (largest) and 2.1 mm (smallest). In the smaller PK Cohort, the reported data shows that all 10 frontal sinus openings attempted were successfully dilated using the drug-coated device, meaning the balloon was fully inflated twice as required by the study's definition of success. Openness measurements in the PK Cohort varied across the reported time points, ranging from 1.1 mm to 4.1 mm depending on the measurement and timepoint. The reported data also shows that for the PK Cohort, a symptom questionnaire called the SNOT-22 (a 22-question survey where higher scores, up to 110, indicate more severe symptoms) was recorded at multiple timepoints: scores of 45.0, 21.2, and 27.6 were reported across the follow-up period, though the specific timepoints for each of these scores were not detailed in the submitted data. No further breakdown of adverse events or other outcomes was included in the structured data submitted to ClinicalTrials.gov. 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.
Chronic Rhinosinusitis Trial, Completed
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:
- You have been diagnosed with chronic rhinosinusitis (long-term sinus inflammation) according to recognised medical guidelines.
- A CT scan taken within the last 30 days shows sinus disease affecting both sides of your frontal sinuses (the sinuses above your eyes).
- A camera examination of your nose shows that the openings to both frontal sinuses are blocked by scarring or swollen tissue.
- Doctors have determined that it is safe and suitable for you to have a balloon procedure to open up the frontal sinus openings.
- You have previously had sinus surgery (more than 30 days ago, with fully healed tissue), including removal of specific structures that help doctors see the frontal sinus openings clearly.
- Doctors have confirmed that a specific size of balloon (6mm) can safely be used to open both frontal sinus openings.
Who may not be able to join:
- You have a large amount of nasal polyps in a specific area of your sinuses beyond a certain level (confirm with trial site).
- You had complications from previous sinus surgery or balloon procedures, such as a fluid leak around the brain or damage to the skull base.
- You have a history of a condition called aspirin-exacerbated respiratory disease, where aspirin or similar painkillers worsen your breathing.
- You are a current smoker.
- You have a known allergy or bad reaction to a steroid medication called mometasone furoate.
- You rely on steroid tablets taken by mouth to manage an ongoing health condition.
- You currently have an acute (sudden) sinus infection, a serious fungal sinus infection, or another illness that could affect your safety or ability to complete the study follow-up appointments.
- You have used steroid injections (such as Kenalog) in the 30 days before your procedure.
- You have used steroid tablets, steroid nasal rinses, drops, or inhaled nasal steroids within a certain number of days before the study begins (confirm with trial site for exact timing).
- You have glaucoma (raised pressure in the eye) or a specific type of eye condition called a posterior subcapsular cataract.
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.
GP referral letter
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Trial details
Where this trial is recruiting
Primary endpoints
Randomized Cohort: Difference in Patency Grade of FSO; The Number of Participants in the PK Cohort With Successful Dilation of Attempted FSO at Baseline
Can't join this trial?
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.