The National Asthma Education and Prevention Program (NAEPP) of the NIH has updated its guideline recommendations for diagnosis and treatment of asthma patients. Michelle M. Cloutier, MD, from UConn Health, Stephanie Lovinsky-Desir, MD, of Columbia University Irving Medical Center, and JAMA Associate Editor George O'Connor, MD, MS, from Boston Medical Center join JAMA's Q&A series to discuss what's new, including revised advice about
• Use of intermittent inhaled corticosteroids (ICSs)
• Use of add-on long-acting muscarinic antagonists (LAMAs)
• Use of fractional exhaled nitric oxide (FeNO) measurement as a diagnostic biomarker
• Monitoring response to therapy
• Indoor allergen mitigation strategies
• Safety and efficacy of subcutaneous and sublingual immunotherapy
• Use of bronchial thermoplasty.
Recorded December 8, 2020.
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>> Howard Bauchner: Hello, and welcome to Conversations with Dr. Bauchner. Once again it is Howard Bauchner, Editor in Chief of JAMA. And I'm joined by three individuals. And we're not talking about COVID-19. I know there's a lot of news about the vaccine and the NHS rolling out their vaccination program. But we're going to talk about an issue in healthcare in the United States and around the world managing asthma in adolescents and adults, which impacts virtually every clinician in the world. And I'm delighted to be joined by the first author of this special communication, Michelle Cloutier. Michelle is at the Institute for Collaboration on Health Intervention and Policy, and she's director of the Asthma Center at the Children's Center for Community Research Connecticut Children's Medical Center. And I'm joined by two of our editorialists, Stephanie Lovinsky-Desir. Stephanie's an assistant professor in the Division of Pulmonology, at Columbia. And her co author on the editorial is George O'Connor. George is an old friend and a colleague. He's our associate editor in pulmonary, and he's a Professor of Medicine at Boston University School of Medicine. They've authored the editorial entitled Evolving Strategies for Long-term Asthma Management. But, Michelle, I want to start with you. You're the senior author, the first author on this remarkable special communication, entitled "Managing Asthma in Adolescents and Adults, 2020 Asthma Guideline Update From the National Asthma Education and Prevention Program. So Michelle, how long did this take you to do?
>> Michelle Cloutier: The expert panel was convened in July of 2018. And we felt the pressure to try and get the recommendations done quickly. And the first draft of the recommendations actually came out last year in December. But as you know, there is a federal clearance process that was challenged by COVID to get it through the federal clearance process, to get it put into final form. So it took about an extra year really, in order for us to do that.
>>> Howard Bauchner: It's a it's a remarkable document. I think all of us are used to those tables and graphs that have accompanied the previous reports. And I remember I think the first report I read like 20 years ago is like 400 pages long and I go, can anyone ever read a 400 page guideline? This one is shorter, but it's long. It's focused on six areas and we'll go through each one. The first of pharmacotherapy, intermittent inhaled steroids, use of long acting muscarinic, antagonists LAMAs as add on. Utility of fractional exhaled nitric oxide allergen reduction strategies, role of subcutaneous and sublingual immunotherapy, and bronchial thermoplasty. George, you've been taking care of patients with asthma for 30 years. When you read this document, what's new? What's novel? What's important?
>> George O'Connor: Well, you know, perhaps one of the most important changes that is new in terms of these US guidelines is pharmacotherapy and the inhalers we use. Because this is the bread and butter every day management, long-term outpatient management of patients with asthma involves inhaled therapy, inhaled corticosteroids, long acting beta agonist, et cetera. How you use short acting quick relief beta agonist. And the new recommendations that Michelle and her group has put out to guide us have really a paradigm shift in how we do this. Previous iterations of the guidelines have focused on inhaled corticosteroids as the controller or preventive therapy being used regularly every day on a twice daily regimen or some inhaled steroids are not recommended labeled for once daily administration. But the paradigm was always regular every day use to control asthma and prevent exacerbations. And then you supplement that with as needed short acting beta agonist, typically albuterol when you're having symptoms. The new guidelines have a paradigm shift. Many, many patients with asthma now can be recommended as a preferred therapy to use either, you know, for mild persistent asthma, one could use the inhaled corticosteroids intermittently guided by symptoms. So, you know, you could take as needed inhaled corticosteroid plus short acting beta agonist for quick relief. And for more moderate persistent asthma, where a patient clearly needs everyday inhaled steroid, one can use what's called the single maintenance and reliever therapy approach with the acronym SMART often applied to it. The SMART approach, though, a combination product with inhaled corticosteroid and Budesonide in the same inhaler. Use it regularly, but also as needed PRN asthma symptoms so that every time you need quick relief, you're using the inhaled corticosteroid, Budesonide, you get the -- I'm sorry. You're using the inhaled corticosteroid formoterol. I misspoke, using the inhaled corticosteroid formoterol. And you're getting the quick relief of the formoterol, which is also a long acting beta agonist, but you're getting more inhaled steroid. So in a way, you're sort of auto titrating, the amount of inhaled corticosteroid to how much symptoms you're having. So this is the single maintenance and reliever therapy. You're using the inhaled corticosteroid formoterol for your maintenance, but also the inhaled corticosteroid formoterol for extra doses as needed. So for both the SMART approach, and for the milder patients who are using the inhaled corticosteroid as needed, the paradigm shift is essentially the option for intermittent use of inhaled corticosteroid or variable amounts of inhaled corticosteroid, depending on your symptoms. And this is sort of a paradigm shift in what we were doing before.
>>> Howard Bauchner: Stephanie, do you agree with George? Is that your sense their take home message for people who are taking care of adults and adolescents with asthma?
>> Stephanie Lovinsky-Desir: Certainly as a pediatric pulmonologist, I can say that this will be significantly paradigm shifting for the care of my patients, especially those families who don't necessarily have younger children buy into using daily medication when their children are having intermittent symptoms. I think this option, this additional intermittent use of inhaled steroids I think will be quite meaningful for those patients. And I think I agree that's probably one of the biggest changes. I'll also add that I think the use of fractional exhaled nitric oxide, which is a biomarker of airway inflammation, that's another sort of big shift in these guidelines updates is the use of that in conjunction with other parameters to monitor asthma therapy. I think that's another big change.
>>> Howard Bauchner: We'll return to that in a second. Michelle, was that the intent? When you looked at the evidence report, and then tried to consume it and put it into recommendations, George and Stephanie's comments about this kind of shift in the way that from Adderall and steroids are used, was that the intent?
>> Michelle Cloutier: Yes, it was. And I think it's important to sort of understand a little bit about the background --
>>> Howard Bauchner: Go ahead.
>> Michelle Cloutier: -- the guidelines. And the background of the guidelines was the decision of what questions to address.
>>> Howard Bauchner: Right.
>> Michelle Cloutier: What to actually update was made by the National Heart Lung and Blood Advisory Council based upon a national survey of primary care clinicians, specialists, patients, advocacy groups of what they felt were the important questions that needed to be addressed, and for which there was sufficient new evidence to actually come to a conclusion or a recommendation. And so, that's why this use of intermittent inhaled corticosteroids came up. And I think Stephanie's comment about families not wanting to use, and particularly in children, and both of us are pediatric pulmonologists, by the way. Yeah, families not wanting to use a medicine every single day, especially when their child was [inaudible]. And so along with pediatrics, as well as what's clearly been documented in adults, there's a tremendous amount of non-adherence to daily medication. So one of the goals of our update was to address the issue of who can use intermittent inhaled corticosteroids. And when used, are they as effective as daily use?
>>> Howard Bauchner: In the document, I just want to point out people will be able to read it. It's free up on our website is the Figure Stepwise Approach for Management of Asthma in Individuals Aged 12 Years and Older. I'm sure it's going to be reproduced in every talk people give on asthma. And then there's an accompanying table, Recommendations for Pharmacologic Step Therapy for Managing Asthma in Adolescents and Adults. I think that figure in that table will be part of kind of mandatory asthma education. Stephanie, I wanted return to one of your comments because it is one of the sections that I think really has evolved over the last decade. Certainly since when I was an intern or an attending, and that's the use of fractional exhaled nitric oxide. Could you say a little more about that?
>> Stephanie Lovinsky-Desir: Yeah, so as I mentioned, we think of exhaled nitric, oxide fractional exhaled nitric oxide as a biomarker of airway inflammation. And I think, as clinicians, we're often looking for tools to help us confirm diagnosis of asthma as well as monitor the progression of disease, and, you know, response to therapies. And I think in this new update of the guidelines, there's been added to our kind of toolbox, so to speak, of resources to use for management of asthma is the addition of this biomarker, exhaled nitric oxide. And I think the guidelines are quite clear in pointing out that FENO should not be used in isolation in terms of making the diagnosis of asthma, or titrating medications based solely on FENO. But I think it can be sort of an added option to supplement our clinical questioning and as well as pulmonary function testing risk vibrometry that we often use to make decisions about asthma management.
>>> Howard Bauchner: Is it easy to obtain, Stephanie?
>> Stephanie Lovinsky-Desir: I'm glad you asked that question, because I think the actual maneuver for the ENO is not so difficult. But the part that is important to acknowledge is the fact that it does require additional equipment. It does require personnel to train and learn how to use that equipment, and upkeep. And so I think it's important to think about who is going to be able to use this in their clinical practice. Are we expecting that, you know, the general pediatrician or the general internist who's managing mild or moderate asthma will be able to add this to their specific toolbox? Or is this a tool or a resource that will be used mostly in subspecialty care of asthma? I think that's an important point.
>>> Howard Bauchner: Now, Michelle and George, you're both active clinicians. Do you use this in your clinic? And can you imagine it being used by general internist or general pediatricians, or will they need to be trained on it? Michelle, you first. What's your sense of fraction nitric oxide?
>> Michelle Cloutier: I think it is a very good test. And I think Stephanie very nicely summarized what many of the issues are with that test. I just want to point out one additional concern with using exhaled nitric oxide. And that is, the results can sometimes be difficult to interpret. They are affected by, for example, allergic rhinitis. So you might have allergic rhinitis, or conjunctivitis and not have asthma, but having an, I'll call it an abnormal FeNo measurement. It's affected by smoking, it's affected by obesity. So in addition to just the challenges of the equipment, the maintenance of the equipment, the replacement of the cartilage of the cartridges is the concern about interpretation. So I think it's in all likelihood for most practices, private practices, it's not going to be cost effective. But this is an example where I think the interaction between primary care practices and specialty practices could be really enhanced. So that in primary care clinicians have an opportunity to exchange information about their patient with the pulmonary function lab, or the specialty clinic in order to confirm a diagnosis when other things have not confirmed it, or to help with long-term management.
>>> Howard Bauchner: George, what's your sense? Have you been using it? Do you communicate results to the primary care physicians that you consult with?
>> George O'Connor: No, we've not been using it in our clinic, but actually, I've used it in research studies for many years. So it's really not that difficult to do. As Michelle says, you need to train your staff. Staff needs to be trained, you need to make sure your device is running correctly, that you replace the cartridges and so forth. So there's definitely some quality control involved. Michelle mentioned some factors that can affect the results. In addition, there are certain dietary factors that can affect the results. If you've eaten something, just the particular foods right before the test, that can affect it. So there are some quality and interpretation issues. But, you know, for example, it's much easier to do than spirometry. It's much easier to do this test then to get acceptable and reproducible spirometry data. But I think that Michelle raises, you know, some important caveats in terms of just the logistics and the feasibility of implementing it in primary care practice. I'm thinking that it may more remain in the realm of the specialty practice, but, you know, that that will be determined with time. So we don't use it in our clinical care at Boston Medical Center. But, in fact, for the last year, more than a year, we've been thinking about adding it. So then the way we would implement it at our asthma and pulmonary practice, the pulmonary function laboratories are right there on the same floor.
>> George O'Connor: We would have our pulmonary function staff, you know, trained to do it. And then we could order a fractional excretion of nitric oxide, you know, when together with spirometry, or maybe just the FeNo test, you know, and would be done by trained people that we know we're doing it right, right in the PFT Lab. In fact, we were getting set to do that, and then the COVID situation arose and we sort of, you know, suspended pulmonary function testing in general, you know, due to it being an aerosolizing procedure. So now that things are opening up again, hopefully, we'll be able to keep things open, and we're going to get back to that question of adding FeNo to our pulmonary function lab capability. And of course, these guidelines I think, will be an incentive for us to make sure we push that forward.
>>> Howard Bauchner: I'm always struck that every specialty figures out abbreviations for different terms. FeNo, I've never heard of it before. Like I deal with so many different specialties I can't keep up. I remember I said it before the first time I heard about long haulers with respect to COVID-19, I was trying to figure out why are people telling me about truck drivers? And then I realized they weren't actually telling me about truck drivers. It was an entirely different concept.
>> George O'Connor: But I'll point out how before we leave the nitroxide.
>>> Howard Bauchner: Yeah.
>> George O'Connor: Even if we had it up and running in our clinic, I wouldn't not ordered on every patient because if a patient comes in and they tell me, oh, gee, I'm having wheezing and shortness of breath all the time. I need to use my albuterol frequency. I listen to them. I hear some wheezing. Maybe we have spirometry, it's low. Then the fractional excretion of nitric oxide is not going to help me there. Right? I know that the person is not well controlled. All right. On the other hand, if I had someone who come in and say, oh, since you started me on the inhaled corticosteroid, formoterol, I'm feeling great. I never wheeze. I never need the albuterol. I can exercise. My lungs are clear, the spirometry is normal, I'm probably not going to work there either. Because the number is not going to make me change their therapy when everything else is perfect. So I think it's those patients that have a little more where the decision making is a little more challenging then I think that the nitric oxide can maybe add to these other evaluation tools and help us move in one direction or another.
>>> Howard Bauchner: There's one specific question about nitric oxide. So I'd like to ask Stephanie, is there any home tool to measure it? Is it easy to be done at home, or is it really a clinic based test?
>> Stephanie Lovinsky-Desir: I think they expense of the equipment might prohibit doing it at home. I mean, you have to buy the machine and of itself. And then there are samplers or analyzers that you need for each time that you've run it and that might be cost prohibitive to using it in the home setting.
>>> Howard Bauchner: Yeah. Probably coming to the Apple Watch, you'll breathe into it in it in a, you know, a few years and you'll get the report.
>> George O'Connor: Yeah.
>> Stephanie Lovinsky-Desir: Not sure how accurate.
>> George O'Connor: Of course, there's no evidence base for there being a benefit to do it at home. So that would be a made up sort of approach. Unless there's something I'm not aware of, Michelle, but that doesn't ring a bell.
>>> Howard Bauchner: I want to go on to one of the other sections. I do want to return to use of long acting muscarinic antagonist as the last, because I still think it for individuals with substantial disease that becomes an important issue. Role of subcutaneous and sublingual immunotherapy and treatment of allergic asthma. Michelle, what are the recommendations around this very specific issue?
>> Michelle Cloutier: There are two recommendations. So the expert panel examined the efficacy and the safety of both subcutaneous immunotherapy and sublingual immunotherapy. And came down recommending subcutaneous immunotherapy for individuals five years or older who have allergic asthma and who develop asthma symptoms either seasonally, or in response to a trigger like a [inaudible] or perennially, such as a dust mites, for example. And so, it is recommended. They have a number of sort of additional thoughts about how best to use it. For example, to use it in a clinic setting that's capable of responding to --
[ Inaudible ]
And the opinion of the expert panel. The importance of having subcutaneous epinephrine available for the individuals since a small percentage of side effects occur late after exposure. In terms of sublingual immunotherapy, the expert panel in reviewing the evidence recommended against sub sublingual immunotherapy. I'm trying not to use the abbreviations, [laughs] so I'm trying really hard and it's difficult to speak without using those abbreviations. Sublingual immunotherapy is not recommended specifically for asthma. Now it is recommended for certain individuals with certain types of allergic responses. And it's recommended for individuals who have rhino conjunctivitis. Now, having said that, we know that there are individuals who have both allergic rhinitis and asthma. And so, their asthma might in fact get better when they're allergic rhinitis gets better as a result of therapy. But it's not recommended by the panel, specifically for individuals who have allergic asthma and only allergic asthma.
>>> Howard Bauchner: Stephanie, George, how do you use it in your clinics?
>> Stephanie Lovinsky-Desir: Yeah. I was going to add that Michelle's comments about managing children or patients who have allergic conjunctivitis or allergic rhinitis, in addition to having asthma really hit home, because I think those are the patients that we've seen in our clinical practice who benefit actually from subcutaneous immunotherapy. And I have seen anecdotally many patients who are treated with subcutaneous immunotherapy for their allergic diseases that has also had a benefit on their asthma. And we've been able to step down their maintenance, asthma controller medications as a result to that therapy. So I do think that there is a space for that. This is one of those other things that I think might be limited for a general practitioner to be able to do in their clinical setting, but certainly, especially subspecialty care I think that's a good adjunct to our usual asthma medications.
>>> Howard Bauchner: George, how do you think about desensitization?
>> George O'Connor: Yeah. My approach has been similar to what Stephanie just described, because it's been clear for a number of years that subcutaneous immunotherapy, allergy shots, as most people refer to them, helps people with severe allergic rhinitis. And so, when I have a patient whose asthma is difficult to control, but they're also have a lot of allergic rhinitis, perhaps seasonal allergens drive that, sometimes perennial allergens, those are the patients that I've been more likely to refer to my allergy colleagues to say, you know, in addition to all the asthma therapy, please evaluate this person for immunotherapy because their rhino sinusitis is an ongoing problem as well as their asthma. And then so we've done that in the hopes that, you know, we're also going to get some benefit for the asthma because it was some evidence of that. But I think these new guidelines nicely point out that, yeah, in fact, there is some good evidence for the asthma per se. So I think these will influence my practice a little bit. Though, I have to say the kind of patients that they described here, who for example, have clear cut seasonal asthma that, you know, the spring pollen brings it on. They get really bad asthma in the spring, and not so bad the rest of the year so we do the immunotherapy against the springtime pollens. You know, I work in a large safety net hospital with a lot of urban patients. It's not so much the pattern I see. I tend to see more patients with perennial symptoms multiply sensitized and so forth. As opposed to the, you know, the spring pollen person who gets exacerbations of the asthma every spring or someone who doesn't live with cats, but you know, occasionally must come into contact with a cat so we do immunotherapy. Let's say you had a patient who was a cat allergic veterinarian, didn't have cats himself, but then had to see cats as part of his veterinary practice. It might be a great candidate, you know, for immunotherapy, his cats, something like that. So again, I think that up to this point, I've mostly saved that for patients who also have the allergic rhino sinusitis situation. I think these guidelines might influence me to think about it a little bit more if I have patients who need those particular criteria. You know, clear cut allergy to particular allergens, exposure to those allergens, where it's clear that those exposures are driving their symptoms, perhaps just in part of the year, that might be a good candidate for subcutaneous immunotherapy, in addition to of course, all our usual asthma control events.
>>> Howard Bauchner: Michelle, I want to go on to bronchial thermoplasty. The recommendations are much more restrained. But before you could talk about what the committee recommended, could you tell our listeners what it is? It's, I think, for you all you may chuckle when I say that, but could you just explain what bronchial thermoplasty is, and then what the recommendations are?
>> Michelle Cloutier: We know that in people who have asthma, they have smooth muscle hypertrophy. And this smooth muscle hypertrophy can affect the caliber of the airways. And by decreasing the caliber of the airways this reduction results in an increase in airway resistance, which is a part and parcel of asthma. And so what bronchial thermoplasty does, is, it is completed by an interventional pulmonologist using a bronchoscope, especially device bronchoscope that uses heat to shave carefully a small amount of muscle from the airway, thus, as a result, increasing the caliber of the airway and decreasing the airway resistance. So that's what Bronco thermoplasty is. Done over three times, it's three procedures with the bronchoscope.
>>> Howard Bauchner: The recommendation from the committee?
>> Michelle Cloutier: We recommended against bronchial thermoplasty as a standard measure of asthma care for a variety of reasons. And the first and foremost is the studies that have been done of which there are three, some with longer term follow up than others show small benefit, moderate harms, and unclear long-term effects. It just hasn't been around long enough for us to understand what the long-term effects of it are. And so, the committee felt that this is not something that we would recommend. However, there's a caveat. And the caveat here is, there are some patients, some adults, now it's only recommended in those over 18 years of age. There are some adults who just cannot tolerate asthma therapy, for example, for whatever reason. And I can list a couple, but they just don't tolerate it and they're not doing well. And for them that increased risk of the procedure is offset by the small potential for benefit. And so for them, this might be a reasonable therapy. It's part of that shared decision making that is so stressed in these new guidelines, that this is the conversation that clinicians must have with patients so that they come to a consensus opinion because now we have choices. And we consider in strong terms patient preferences, and beliefs. We want bronchial thermoplasty, however, to be done as part of a registry or long-term follow up so that we can gather the information that's necessary in order to make a more informed recommendation as we move forward.
>>> Howard Bauchner: George, any experience with it, and what's your sense of the committee's recommendations?
>> George O'Connor: I think Michelle has summarized it really beautifully. And I think I agree that the committee's cautious restraint in this regard. It's very interesting, as Michelle points out, there are randomized clinical trials showing some benefits. But unfortunately, you know both treatment and control groups were not followed out for enough years for us to be able to see the long-term impact. Is this something, you know, you have three separate bronchoscopy, as Michelle points out, it's not without risk, would it need to be repeated every four years, or we know, we just -- questions that are unanswered. So I think their restraint was appropriate and I agree with their recommendations. And I have not yet referred a patient for bronchial thermoplasty because of these cautions and concerns that Michelle raises. I recently have the first patient that I've encountered that I've been thinking about it though. Again, just because someone who is not a has had life threatening attacks requiring intubation. Other therapies, including biologics don't seem to be solving the problem. And so, you know, there's the occasional patient where one might want to think outside of the box and do consider something that you wouldn't consider for most patients.
>>> Howard Bauchner: Stephanie, we started on steroids, which was pharmacotherapy intermittent inhaled corticosteroids. Now I want to return to it. It's the second major section of the guideline, and I think, you know, fractional exhaled nitric oxide, subcutaneous sublingual immunotherapy, and now, bronchial thermoplasty. They may stay in the purview of specialists like the three of you. But use of long acting muscarinic antagonists LAMAs, as add on therapy will not. That will be done often in pediatric practices or adult primary care. Can you talk about the recommendations about the use of LAMAs?
>> Stephanie Lovinsky-Desir: I think that's a very appropriate point, because I think that what the guidelines have given us this time around, or this version of the update is more options. Right? And I think Michelle actually mentioned this earlier, the idea of a shared decision making being integral to the guidelines as they've been updated this time around. So the guidelines recommend for the use, the addition of muscarinic antagonists, particularly in patients who have moderate to severe asthma, and I think it's, again, another opportunity to have conversations with families, about and parents adults as well, because I think this end up being used more often in the adult population, about the use of how many inhalers you have at home. How many can be used for the SMART therapy that was mentioned earlier by George, using the same inhaler for both chronic daily use of inhaled steroids in addition to as needed. Same with the in health muscarinic receptor antagonists. So I think it's the idea of having more options in the toolbox and the toolkit to use for management of asthma will be very helpful and useful for the general practitioner.
>>> Howard Bauchner: Michelle, the guideline recommendations around LAMAs, what was the intent?
>> Michelle Cloutier: I think the goal of the recommendations is to place add on LAMA therapy, in terms of the spectrum, of management of asthma. And so, the recommendations themselves talk about how to use add on LAMA therapy. So, for example, a long acting beta agonist is recommended over a long acting muscarinic antagonist. So when you're thinking about the two, the LABA is preferred over the LAMA. But we know that there are individuals who cannot use long acting beta agonists, for whatever reason. Sometimes it's not available, in which case, the long acting muscarinic antagonist can be used instead. So we begin to see this hierarchy of when to use it. And then, there are individuals for whom an inhaled corticosteroid plus a LABA, long acting bronchodilator is insufficient. Their control is inadequate on that therapy, and then adding on to that a LAMA may be useful. Again, small benefits, small incremental benefit. But there were two caveats to the LAMA therapy. One Stephanie mentioned, which is it is an entirely different inhaler device. And so, we have to train families and clinicians how to use this inhaler device. The guidelines recommended only in 12 and up, although LAMAs are now approved for six years and up. So it will come into pediatrics more over the course of time. And the second is a very small caveat, but one that the expert panel wanted people to be aware of. And this is a very large real world study in blacks. And in this study called the Belt Study, again --
-- individuals on LAMA had a higher rate of hospitalization. And also had a numerically increase rate of death. There were two deaths in the intervention, the LAMA group as compared to the control group. And so, the committee, that information is what persuaded, convinced the expert panel to put a LABA, the long acting bronchodilator ahead of the LAMA, even though the outcomes were quite similar. But to put it ahead of it, but to say, but, you know, if things aren't going well, or you can't use it, then the long acting muscarinic antagonist is acceptable to use.
>>> Howard Bauchner: Thank you. There's a few questions. I'll go around. And then I want to finish with one or two last questions. So I'll just go around the circle. George, any concerns that increased use of steroids will have a greater likelihood of suppressing growth rate in young people? Actually, I won't use you, George, because you're the adult physician. Stephanie, you're the pediatrician. So any concerns that increase use of steroids will suppress growth rate?
>> Stephanie Lovinsky-Desir: Yeah. This is an important topic and one that I actually had this discussion with a lot of my patients, especially when you're thinking about using inhaled steroids at the higher doses. I think that might be one of the benefits to using intermittent inhaled steroids is that we're not using chronic high dose inhaled steroids, and that we're using it specifically targeting exacerbations. And certainly we know that the dosage of an oral steroid or an intravenous steroid is way higher than that of an inhaled steroid. So if this approach to intermittent use of inhaled steroids could actually prevent the need for systemic steroids. I think that could be a benefit.
>>> Howard Bauchner: George, what's the best SC? I assume subcutaneous immunotherapy for Rhino conjunctivitis and asthma. Do you have a particular approach that you like?
>> George O'Connor: Well, I'm not even going to take that one, because remember, I'm an adult pulmonologist. I'm not an allergist. So if the question is how specifically do you do the immunotherapy? That's not my bailiwick. I would refer to my allergy colleagues who are right there with me in clinic seeing patients right next to me, but I defer the immunotherapy to the allergists.
>>> Howard Bauchner: Okay. Then you get the next question. How [laughs] does FeNo, is that how you call it FeNo?
>> George O'Connor: Well, fractional excretion of nitric oxide. We just call it FeNo because it's so much quicker.
>>> Howard Bauchner: And someone emailed me it's also a very good Sherry, but we'll put that aside. [Laughs] How does FeNo relate to airway management and other respiratory illnesses?
>> George O'Connor: Well, actually it's not really known to have a role. And, in fact, in smokers and in people with COPD, the fractional excretion of nitric oxide can be lower. Now, one interesting thing with this is a much rarer disease. It turns out that the nasal excretion of nitric oxide is very high in primary ciliary dyskinesia, and so it's a very good diagnostic test. This is in very specialized centers measuring the nasal FeNo to help establish a diagnosis of primary ciliary dyskinesia. But other than that use and in asthma which we've been talking about, to my knowledge, it doesn't have any other clinical application. Michelle, am I missing anything there?
>> Michelle Cloutier: Not that I can think of, George.
>>> Howard Bauchner So Stephanie, now go round for the last questions. So, you know, you're about to go on a speaking tour about these recommendations, because they're extensive. They're so important. I'm sure you're going to be asked to speak both at your own institution as well as around the country. And you're going to be talking to primary care physicians. What are the two or three points that you really want them to take home? It's a long document, and I worry that guidelines become so complicated that people throw up their hands. That's happened a bit with hypertension, what's the right way to measure it? How do you treat it? I worry that the guidelines are becoming so complicated it's very hard for primary care physicians. What would be your two or three take home messages?
>> Stephanie Lovinsky-Desir: I think that the main guidelines that hit home the most for me as a pediatric pulmonologist, as we've discussed a couple of times so far is this intermittent use of inhaled corticosteroids for mild charismatics. As well as the SMART therapy or using inhaled a combination inhaled steroid with the long acting beta agonist formoterol, both daily, as well as intermittently for asthma exacerbation. That I think is one of the biggest take homes. I also think the addition of -- they're three other things. I know you told me two or three, right? I can think the three other take homes I'd like to add. Just thinking about using fractional exhaled nitric oxide in clinical practice and thinking about investing in that equipment and what potential gains there might be in adding that to our clinical practice I think is an important step. The third, we didn't have much time to speak about it on this today, but there's also a guidelines recommendation about environmental remediation --
>> Stephanie Lovinsky-Desir: -- for allergens, particularly for patients who have significant allergic disease, and that trigger their asthma and thinking about a comprehensive, multifaceted approach to targeting allergens in the environment and reducing those allergens to benefit asthma. I think that's another big area. And then lastly, I would say the subcutaneous immunotherapy thinking about, as George mentioned, referring to our allergy colleagues, and those patients who have severe asthma, but also have allergic disease and thinking about targeting their asthma therapy in that way. So I think those are sort of the four take homes for me that hit home.
>>> Howard Bauchner: George, when you get referrals, you know, from the network at BMC. You know, what are the consistent struggles that primary care physicians are missing that they could do a better job at? And really, you're just fine tuning. Where are they really struggling?
>> George O'Connor: I think primary care community actually is doing a reasonably good job because I think they realize now that inhaled corticosteroids and inhaled corticosteroids combined with LABAs are like a mainstay of therapy. I think, though, that it's, I think that repeated visits with a patient measuring spirometry, assessing the control in a very detailed way. And then really hammering home over multiple visits, the action plan. You know, the regular use of inhaled steroids, if that's appropriate. What's to be used as needed? What's to be used on a regular basis? How you monitor your symptoms and action plan for, you know, when do you need to call me? When do you need to start prednisone? In the specialty setting, we can just take more time with that. And we can do it over multiple visits. Whereas the primary care doctor who's dealing with many different issues, you know, asthma may be one of five things on the list that they're dealing with and in 20, 15 or 20 minute visit, and they just may not have time to drill down on all those things. So I'm not sure there's like a magic bullet we do that they don't do, but it's just that our familiarity with all these issues. And I do want to mention one thing that is deliberately not part of these guidelines. But another reason for referring to a specialist for the patient who's having problems is the use of biologics for asthma. And these guidelines don't address, you know, the use of biologics for asthma, which are not done by primary care doctors, it's done by specialists. But the, you know, the mepolizumab, omalizumab, reslizumab, benralizumab [inaudible], we now have multiple biologics that target various pathways for the more severe difficult to control asthmatics that we cannot control with ICS, LABA, and LAMA, and so forth. So I think an important message is that to not only for evaluating allergy, deciding Is there a role for subcutaneous immunotherapy, is FeNo is a excretion of nitric oxide going to help us, et cetera? But also for consideration, is this person's asthma so bad that they would warrant a biologic, I think is important for primary care doctors to understand what the specialists armamentarium is that they could add to, you know, what's available in the primary care setting.
>>> Howard Bauchner: Michelle, last question goes to you. And really I do really want to thank your co authors and the entire committee and the evidence report. You know, when you started this three or four years ago, you probably had a preconceived notion of what the evidence would show. What have been the surprises when you look at the entire evidence base in the six or seven categories that you've considered, what were the real surprises?
>> Michelle Cloutier: The major surprise is actually not in the recommendations per se, but rather, in the data that support the recommendations. And there's a -- one of the real challenges for us in using the platform assessment tool that we used was the absence of consistency across studies in outcomes, in how outcomes were measured, in what outcomes were measured, and in characterizing the patient population, so that we could actually make recommendations that were either very broad, or that were very narrow. And so, I guess my plea is to individuals who are doing research in the area of asthma management, to use the recommendations from the Asthma Outcomes Workshop for what outcomes are critical to assess the efficacy of an intervention or a course of action, and which ones are important. To use ones that have minimally important differences. You know, it isn't just simply a matter of a statistical difference. Is this difference clinically meaningful? And so from a perspective of having written this guideline, that kind of information would have gone so far, would have been so very useful in making stronger recommendations. A lot of people have said, you know, only three of the recommendations are strong recommendations. The rest are conditional. Patients will want them, some patients will not want them. And we can do a better job of making those recommendations if we can come to agreement as a community. Now I'm speaking obviously the specialty community of what's important and how to measure it.
>>> Howard Bauchner: This is Howard Bauchner, editor in chief of JAMA, and I've been talking with Michelle Cloutier who's the first author of this special communication published last week in JAMA and then in this week's issue, Managing Asthma in Adolescents and Adults 2020 Asthma Guidelines Update From the National Asthma Education and Prevention Program. Michelle is a professor of pediatrics and medicine School of Medicine, UConn Health. And the author of the two and the two authors of the accompanying editorial, Stephanie Lovinsky-Desir, who's an Assistant Professor of Pediatrics at Columbia. And my very good friend and colleague, George O'Connor, who's a professor of medicine in the Division of pulmonary Allergy Sleep and Critical Care Medicine at Boston University School of Medicine. I really want to thank the three of you for taking time out today and adding clinical texture to a long document. I'm sure the three of you are going to be very busy the next year or two talking about these recommendations. So thank you so much for joining me. Stay healthy and season's greetings to the three of you.
>> George O'Connor: Thank you, Howard. Thanks for inviting us.
>>> Howard Bauchner: Bye-bye.
>> Stephanie Lovinsky-Desir: Thanks so much.
>> Michelle Cloutier: Thank you for having us.
>> Stephanie Lovinsky-Desir: Take care.
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