Large Volume Corticosteroid Delivery System for Nasal Polyposis

Anju Peters, MD:Drew, would you please talk to us about the large volume corticosteroid delivery devices.

Andrew White, MD: I'll start with a description if you're not familiar. The idea behind this it's the classic saline rinse, and it's a large volume of fluid. It's mixed with a salt and usually a baking soda type of solution it's the same consistency as tiers or saline. It's not particularly irritating and it's very helpful in these large volumes to dislodge adherent mucus and help to clear out the nasal passages and it's going to get much higher up into the nasal passages around where- in patients who haven't had surgery or around where the osteo are to their sinuses, and then in patients that have had surgery can even get up into their sinuses. And the idea is to try to deliver this large volume of fluid and the idea had maybe 15 years ago or so as to put steroids into this as a way to deliver the medicine where we think the problem is occurring. And that's the general idea here. There's a lot of options for what clinicians over the years have added to sinus rinses. Probably the 2 most common have been mometasone or and budesonide. And those are both steroids that we have a lot of comfort with as allergists, and ENT doctors. They're used in nasal sprays for many, many years, and inhalers for asthma, we have a confidence in the medication itself there's a couple problems with this. Mometasone isn't available. You must get it compounded and then it can be added, there's going to be a cost and it's not FDA approved for this indication. With budesonide, it can be what's often used is the nebulizer solution for asthma, and that same exact medication is then mixed into the rinse and then that is flushed with this high-volume rinse. That's the sort of the general idea behind it. All of us have patients where there have been anecdotally very successful. The patients feel better and for many years this was one of the biggest things that we had because a lot of patients don't have a satisfactory response to the typical intranasal sprays. Some of the problems here, as I mentioned, these are not FDA approved, they have not gone through as rigorous of a study in terms of outcomes or safety. And with both the mometasone or the budesonide or any of the other steroids that would be mixed in, we're left with a little uncertainty as to exactly whether these are effective or how effective. Maybe there are certain situations like postoperatively where they're more effective than others, but we just we don't know and we can assume a certain level of safety, but we also don't know that because it hasn't- none of these have needed to go through a rigorous safety evaluation. That’s the idea there with the rinses. The other way to deliver steroid in a sort of a similar area with the idea that you're getting past the bottom of the nose where the nasal steroid sprays is using fluticasone but with a different delivery system called exhale delivery system. And with that, there's the same medicine that we're familiar with, there's a different device. You exhale into it, and when you do that, it closes the vellum in the back of the nose and creates a closed chamber. The medicine will then go up one nostril and it will go up much higher into the area where the polyps often originate and then travel back around the other side. And that is another mechanism, and it has the same general idea of the purpose of the rinses, but in this situation, it has gone through more rigorous evaluation and safety studies that we'll talk about in a little bit.

Transcript edited for clarity