Jay Piccirillo, MD, an Otolaryngologist at Washington University St. Louis talked about chronic sinusitis and how a combination is showing better results.
Interview conducted by Ivanhoe Broadcast News in August 2019.
Tell me about the study and what is this for?
PICCIRILLO: We’re studying the use of a nasal saline lavage like a neti pot with the addition of a steroid medicine, a topical steroid, that is a steroid that goes against the skin, for the treatment of patients with chronic rhino sinusitis or sinusitis.
And what is chronic rhino sinusitis?
PICCIRILLO: These are people that have fullness in the nose, pressure in their nose, decreased sense of smell, green yellow discharge for anywhere of a number of weeks generally over say three months or so. And oftentimes they’ve had antibiotics, taken decongestants, and they just can’t get better or they have these conditions on a repeat or recurrent basis.
Is this sinus infections?
PICCIRILLO: Yes. Lots of people have sinus infections and oftentimes they’ll follow a common cold. But when that common cold leads to a sinus infection, that sinus infection just doesn’t seem to go away, that then becomes the chronic sinusitis patients that we’re looking for, or as I said before people, that have these episodes over and over and over again.
How common is this and who is most affected?
PICCIRILLO: We think people that maybe have allergies already like dust, ragweed, pollens – people with allergies are more susceptible to the chronic condition, the inability of that sinus to get better after the virus.
But it is common, people of all ages?
PICCIRILLO: Yes. We all get a virus or a cold up to two times a year normally. Maybe about 2 percent of people will then after the virus infection will get a bacterial infection, and then again a small percentage of those people will go on to have this sinusitis for upwards of three months or so. It’s a small percentage of a small percentage but when you think about all the people in America that have a viral cold, particularly between the months of November and March, it’s a large number of patients. A large amount of antibiotics are being used. A lot of people are missing work because of this. There are some other possible complications – rather rare, but there are complications to the surrounding areas like the eye and the brain also.
This can really interrupt day to day life. This isn’t just I’m not feeling so well. This can really be a pain for people who have it.
PICCIRILLO: People are bothered by this constant postnasal drip sinus facial pain and pressure discharge because they can’t sleep at night, then they wake up and they feel tired. They don’t work as well at work. They have to miss work. Oftentimes they’re prescribed multiple rounds of antibiotics, which have their own costs and side effects. And so when the patients get to us, they’re pretty miserable.
What’s the new part? Are both of these parts new that you’re studying or is it the combination that’s new?
PICCIRILLO: In some way the two components of our study, the nasal lavage and the topical spray, have been around for a long time. We think probably the nasal lavage has been around for five or six hundred years, maybe. So that’s an old treatment, if you will. The topical sprays have been around for about 20 to 30 years, they’re very safe. They’re widespread. They’re over-the-counter at this point. So what we’re investigating is the application of the steroid medicine into the nasal lavage and whether the addition of steroid medicine to the lavage is more effective than just using the lavage alone.
And what’s the name of the drug?
PICCIRILLO: The name of the steroid medicine that we’re using is budesonide. It’s also known as Rhinocort or pulmacort, but the chemical name is budesonide.
What is that we used for? What is it normally used for?
PICCIRILLO: Budesonide has been around for probably 50 years. It’s one of the safest medications. In fact the World Health Organization has said that budesonide, along with about 100 other medicines, should be on every formulary in every country in the world. It’s that effective and that safe. So budesonide has been around for a while. It’s safe. It is known as Rhinocort, the nasal spray. The inhaler pulmacort.
Is that for asthma?
PICCIRILLO: Budesonide as pulmacort can be used for asthma also. It can also be used for patients with Crohn’s disease. They actually swallow the budesonide. It helps reduce inflammation in their gut.
You said it’s topical but you’re putting this inside the nasal lavage?
PICCIRILLO: So the budesonide medicine is added to the saline, the saltwater lavage. The patient then hangs their head over the sink and actually irrigates both the right and left nasal cavity with the saltwater lavage and the budesonide. So the budesonide is delivered to the inside of the nose with the saltwater irrigation.
And it’s not normally given that way.
PICCIRILLO: This is a new way of delivering the bee budesonide via the lavage, that’s right. It’s typically given either as an inhaler for the lungs or a spray for the nose.
What’s the thought behind it? Why isn’t just as a spray for the nose enough?
PICCIRILLO: We think the addition of the budesonide to the saline spray is more effective than just a spray alone because the nasal saline lavage helps clear out all the mucus that’s in the nose. Our nose and sinuses probably produce at least a quart of mucus a day and people with sinusitis probably produce more mucus. So first we want to clear out that mucus so that the medicine can apply to the nose better. So number one, we think using the nasal saline lavage helps flush the mucus out of the nose to clean the nose out, and then the lavage actually delivers the medicine to areas of the nose that we don’t think the medicine can get to by just using the spray. So the addition of the spray budesonide chemical to the lavage is more effective because it washes out the mucus and it delivers the medicine to more of the places of the nose that are necessary to reduce inflammation.
I see. Tell me about the study. You can just tell me how they were treated. Was it at home? Was it three times a day, once a day?
PICCIRILLO: The patients that we enrolled in our study had chronic sinusitis and they were randomized to receive either the nasal saline alone – again the public knows that as maybe a neti pot or lavage – or they were randomized to receive the saline rinse with the budesonide. The patients were asked to rinse their nose once a day for six weeks.
And then what were the results?
PICCIRILLO: The results suggested that the patients who had the steroid medicine added to lavage had a better reduction in their reported nasal sinus complaints. So for this study, we used an instrument called the sino nasal outcome test or the snot instrument to measure the physical, functional, emotional problems that the patients with sinusitis were experiencing. Each item – on the 22 item scale each item was rated from zero, no problem, to five, the problem is as bad as can be. And so we measured patients’ snot scores both before and after the participation in the study. And what we found is that the patients randomized to receive the budesonide in the saline lavage had a greater reduction in their snot scores suggesting that they were feeling better, and in fact that’s what we found when we asked them all after the study.
Was there a specific percentage, a number that you can give me?
PICCIRILLO: The differences weren’t statistically significant. I’d be happy to talk to you more about that. The differences that we found in the two groups were what we call clinically meaningful. In other words, the change or the reduction in their sino nasal outcomes score – their snot score – was what clinicians and patients would agree was a clinically meaningful difference.
And what does that mean for patients?
PICCIRILLO: We believe that patients who add the budesonide to the nasal saline spray will experience a greater reduction in their symptoms of sinusitis than if they just use saline alone. Now I should add patients in both groups got better. So using the saline lavage by itself is helpful. But what we think is that using the steroid medicine, there’s about a 20 percent extra reduction in their symptoms with the addition of the steroid medicine. And we had no complaints or no adverse events.
Are there any risks of getting it this way or any side effects that you saw that we should talk about?
PICCIRILLO: The budesonide medicine is very safe, as I mentioned. And in fact in my clinical practice we’ve not experienced any side effects. We don’t believe there’s any systemic absorption. In other words, the medicine that we’re placing into the nose doesn’t get into the body. And in our clinical study we didn’t see any adverse events of using the medicine either.
So what’s next? Are you going to continue with a larger study with this or?
PICCIRILLO: What we’ve done is we’ve continued our research into the augmentation or the addition of steroid medicine to the lavage, and right now we’re doing a study of another steroid medicine called mometazone, which is also used in nasal sprays and inhalers like budesonide. Mometazone in the nasal saline lavage is being compared with the nasal steroid spray alone.
For patients with chronic rhino sinusitis, I would definitely recommend that they ask their physician about whether adding budesonide or mometazone or some of the other topical nasal sprays would be appropriate to their nasal saline lavage for their chronic sinusitis.
So they could actually add it to it.
PICCIRILLO: So patients in my practice are oftentimes recommended to use the budesonide in their nasal saline lavage for chronic rhino sinusitis, and I’d encourage the listeners with chronic sinusitis to consider asking their physician about budesonide in their nasal saline lavage and whether that would be appropriate for them.
Do you just use the neti pot and you spray it inside? Is it that easy?
PICCIRILLO: OK so the budesonide comes as either a powder or liquid. And so the patient just adds the powder or the liquid to their nasal saline lavage squeeze bottle. Really couldn’t be any easier than that.
This is safe enough and pretty harmless enough that people could try this right now.
PICCIRILLO: We’re taking these medicines, which I mentioned have been approved for use for inflammation for over 50 years and we’re actually trying a different delivery system. So we’re delivering the medicine through the use of the nasal saline lavage and assessing if that’s more effective than delivering it through the nasal spray approach.
Both of these are things people can do right now and use right now, Right? And big problems.
PICCIRILLO: Yeah, so chronic rhino sinusitis is a huge problem and one of the main problems with it is that multiple studies have shown that patients are treated with antibiotics way too much. And that the use of antibiotics has side effects and adverse events including resistance to bacteria. And it’s a real problem. And so we think the addition of the steroid medicine to the lavage is an alternative to antibiotics, and in fact it’s probably even more effective because at the end probably most of chronic rhino sinusitis is an inflammation problem, and not an infection problem. So medicines like budesonide that reduce inflammation, treatments like nasal saline lavage that clean mucus and help restore nasal hygiene, are going to be more effective than use of antibiotics.
Is it something you only do this when you are having an infection and then you wait for another flare up, I guess? Or could you do this every day to prevent it?
PICCIRILLO: So we think nasal saline lavage should be part of everyone’s hygiene. We brush our teeth. We clip our nails. Many of us think that we should also rinse our nose out with saline or salt water on a daily basis. For many patients with chronic rhino sinusitis, the addition of the steroid medicine can be even more helpful than just saline alone. So we recommend the addition of the steroid medication. However, we also believe that over time the patients won’t need as much steroid medicine as they’re initially prescribed. And we call that de-escalation or reducing the amount of steroid medicine that patients use. And so in my own practice I empower the patients to alter or more importantly to reduce the amount of steroid medicine that they put into their saline lavage depending on their symptoms, and that some patients may actually end up not needing any steroid medicine over the long term. Some patients may choose to add the steroid medicine those times of the year when their allergies are worse, or during the flu seasons – November through March. But in general we don’t think that patients are on the starting dose for the long term. Most patients are able to decrease and some even eliminate the use of steroid medication. But we always ask that they continue at least with the saltwater rinsing on a daily basis.
Thank you. That was great.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
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Judy Martin Finch
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martinju@wustl.edu
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