Two nurse practitioners who specialize in asthma management discuss the important role of primary care in identifying and managing poorly controlled asthma, including when and how to step up therapy and when it’s time to refer the patient to a specialist. NPs and PAs: claim your credit at pce.is/asthma.
Primary care practitioners play a major role in the management of asthma, providing diagnosis, patient education, and management plans. But when the asthma remains uncontrolled, management can be challenging. On this podcast, Corinne Young FNP-C, president of the Association of Pulmonary Advanced Practice Providers speaks with asthma expert Ann Hefel, FNP-C of Children's Hospital Colorado about what clinicians have in their therapeutic toolbox to help patients with moderate to severe disease whose asthma remains uncontrolled despite adequate therapy. This activity is available for CE/CME credit.
YOUNG: Welcome to the Practicing Clinicians Exchange podcast, Optimizing Outcomes in Moderate to Severe Asthma: Utilizing Add-on Therapy for Individualized Treatment. I'm your host, Corinne Young. I'm a nurse practitioner, working in pulmonary critical care and sleep medicine. I'm currently at Colorado Springs Pulmonary Consultants, and I am the president and founder of the Association of Pulmonary Advanced Practice Providers. With me today is Ann Hefel. She is a nurse practitioner, who has worked for National Jewish, at University of Colorado and Children's Hospital Colorado, working in asthma and allergy.
Today, our episode is talking about Managing Uncontrolled Asthma, the Primary Care/Specialist Partnership. And this program is accredited for joint accreditation by Practicing Clinicians Exchange for 0.5 ANCC and AAPA credits, with 0.5 credits applicable for pharmacology credits for NPs. This program is supported by an educational grant from Novartis. And to receive credits for this program at the end, please go to pce.is/asthma.
Our learning objectives for this podcast are that at the conclusion, you will be able to better construct treatment plans for patients with uncontrolled asthma based on disease and patient-centered factors. You'll also be able to implement techniques to increase treatment adherence for improved patient outcomes. So, let's get started.
All right, Ann. I feel like there's a little bit of a perception from pulmonary and asthma allergy specialists that sometimes asthma patients might linger a little bit too long in primary care practices. There's a lot of theories for probably why that happens. But I feel like sometimes, by the time you or I see them in our practice they may have been with their primary care for months or even years, and you find out that sometimes, they've had a very uncontrolled history. Do you feel like you see those types of patients?
HEFEL: Absolutely. And there's even, you know some, some evidence to back that up. So in 2009, there was a review of asthma management done by the National Asthma Education and Prevention Program. And this review found that most patients with asthma reported being uncontrolled, but only 22% had actually been to a specialist. So we definitely see this that, that these patients have been suffering from exacerbations for years and really just skating along, feeling like they’re doing we- they were doing okay. And then they end up coming in to see us, and they've already started to experience some problems with side effects related to oral corticosteroids, or maybe they've struggled in work or school, because they've had a lot of absenteeism.
So, we know that there's a lot of barriers to, to getting those patients in to see us. And that's multifactorial. So, I think it's knowledge about the guidelines and their recommendations because there's many of them out there. I know it's hard to keep up with all of them and practical problems related to the timing and staffing constraints that offices frequently have, ours as well, as well as financial barriers. So, you know, if your patient is uninsured, it might be really difficult for you to find a specialty clinic that can see them or it takes them a long time to get in.
YOUNG: Yeah. And primary care plays such an important role in managing those patients. I mean, they're the front line. They're often the ones that make the correct diagnosis of asthma. And you know, they're setting up the management plans for these patients. And overall, I think they do a great job. But these patients, especially the moderate to severe, the uncontrolled asthmatics, they're difficult for us to manage, you know? And I can't even imagine in a primary care office, where they're trying to manage everything on top of their asthma.
And I know you and I both have talked, and we talked a little bit in the previous podcast that most asthma patients, even if they are uncontrollable say they're fine, you know, or that their asthma is okay, even though it's not. And if you're not doing things like the ACT or doing a little more in-depth digging at them, you may not even catch that they're uncontrolled. So, being uncontrolled may not be very transparent in a lot of these patients, would you agree?
HEFEL: I would. I mean, it's definitely not obvious all the time, you know? Some patients might really tell you that they think they feel good, they maybe get used to feeling short of breath. They get used to needing the rescue inhaler five times a week. So I think that they can be really challenging, and sometimes it's difficult to have enough time to really get into the weeds with them and try to determine what's going on.
YOUNG: So, in our previous podcast, again, we covered a lot of ground about identifying who's uncontrolled, who's controlled and, and that type of thing. But let's just briefly talk a little bit more about the definitions you use as an asthma and allergy specialist for uncontrolled asthma.
HEFEL: So we refer to the Global Initiative for Asthma that recently came out with some new recommendations. But their definition is that a patient is uncontrolled if they have poor control of their symptoms and/or they are having frequent exacerbations. So, people always ask me, "Well, what's considered frequent?" So that would be two or more a year, where they actually require oral or systemic steroids, or at least one serious exacerbation a year, where they ended up hospitalized. If we're thinking about looking at the Asthma Control Test, those numbers, a score of 19 or less is considered to be poorly controlled asthma.
YOUNG: What's your biggest challenge with these patients? Like when you see a moderate to severe uncontrolled asthma patient, what do you feel are the biggest barriers to you or difficulties with these patients?
HEFEL: Sometimes, you really have to get some specialty testing that's not readily available. So, you might have to get particular laboratory studies like CBC, IgE level. You may have to work them up for other comorbid conditions like acid reflux or sleep apnea that are making the asthma difficult to control. This need for testing can sometimes lead to lots more appointments for the patient and delays in care. Also an issue is just missing data and information. So, your patient might be seeking care at an urgent care facility near their home or the ER, and their primary care provider might not know about it, and you might not know about it if you don't have access to those records. And sometimes those patients are presenting to those urgent settings with a primary diagnosis of an upper respiratory infection. But you really find out that it truly was an exacerbation of their asthma.
YOUNG: I think definitely teasing out the "Oh no, I just had bronchitis" versus educating them that well, that bronchitis was likely an asthma exacerbation, and having them really understand the difference between those two has helped. I know with a lot of my patients getting them to kind of change their mindset a little bit of alerting us to those issues.
YOUNG: In your experience, when we talk about common triggers, or factors that lead to them becoming uncontrolled, either with symptoms or with exacerbations, what kind of things are you looking for that you think are really going to cause them to become uncontrolled?
HEFEL: It can definitely be a problem with adherence. So, we know that some patients don't take their medication. So should we say all patients don't take their medications all the time. (laughing), and that adherence, it's good to tease out why they aren't taking it. So, is it because it's too expensive? Can they just not remember it? Do they not like how it makes them feel? And maybe you can spend some time trying to find a therapy that won't give them side effects. You can have poor inhaler technique, so they're not taking the inhaler the correct way, and they're not getting the full dose of their medications.
Maybe they have a constant allergen exposure like a beloved pet that they, they definitely won't get rid of, but perhaps you can offer some tips like keeping them out of the bedroom, that might help with controlling their symptoms. And then exposures like smoking or perhaps they are a construction worker or in a field where they have frequent exposure, like in the marijuana industry, we see that here in Colorado, definitely. Or they just have other comorbid conditions, which we've talked about before like sinus disease or heart disease.
YOUNG: Yep. And definitely reflux.
HEFEL: And reflux, yes.
YOUNG: Oh, yeah, reflux is. I'm keeping the PPI business going, I feel like single handedly.
All right. So now, let's talk a little bit about from a primary care perspective. If you were to be the little angel on their shoulder, you know, when they're seeing these patients, how and when would you have them start talking to their patients about step-up therapy? And then help us with understanding step-up therapy.
HEFEL: Yeah. So when you, when you see that patient, if you see that they're having frequent symptoms, they are coming to you with exacerbations, or maybe they've been hospitalized in the last year, that's when we need to think about stepping them up. one thing that's changed recently with the guidelines that we see with GINA, or the Global Initiative for Asthma, is a change to step one treatment.
So as the primary care provider, you may be the very first person to see this patient and diagnose them with asthma. And step one treatment for the mild intermittent asthmatics has always been a short acting beta agonist on an as-needed basis or before exercise. So, GINA is actually no longer recommending this. So, they've made a transition to recommending that these patients take an inhaled corticosteroid with their short-acting beta agonist when they have symptoms, or they take an inhaled corticosteroid and formoterol, which is another type of LABA combination. And there's a lot of reasons for this.
So they found that even mild asthmatics are actually at an increased risk still for having problems related to their asthma, whether it's asthma-related death, asthma-related hospitalizations, or decreased lung function. And the patients that are just using short-acting beta agonists and using them frequently are at an increased risk of having increased allergic responses, as well as airway inflammation.
Now I should point out that inhaled corticosteroid formoterol combination therapy really has not been approved by the FDA in the United States as a symptom-driven treatment at this time. But these just are the new GINA guidelines, which we wanted to touch upon as it's something that you've probably been hearing a lot about and, and others have been hearing a lot about in the asthma world.
YOUNG: Sure. So, just to clarify: The symptom-driven treatment, meaning they're not on ICS/LABA maintenance therapy. They basically would be on maybe just an ICS or just their short-acting. And when they became symptomatic or exacerbated, then they would initiate the ICS LABA therapy with their short-acting for symptoms or for exacerbations?
HEFEL: So, the symptom-driven. So, if they were, to say, having coughing or a respiratory infection, then, they will start using their ICS and their short-acting beta agonist, or they also state that you can use the ICS formoterol combination. And it's only the formoterol that they have data on, this is not a recommendation for salmeterol or other long-acting beta agonists at this time.
YOUNG: Okay, thank you. Thank you for clarifying that.
So, that PRN dosing you're talking about, I think really speaks to how medicine is trying to really drill down specific treatments and tailor treatments to patients. How else are you tailoring your treatments for your uncontrolled moderate to severe asthmatics?
HEFEL: We're talking to the patients, and we're trying to find out what type of asthma they have or what their phenotype is. So, are they an allergic asthmatic that might benefit from a therapy like omalizumab or allergen immunotherapy? Are they an eosinophilic asthmatic that might benefit from one of the interleukin-5 biologic therapies that have recently come out in the last several years? And then also, just finding out from the patient, what is gonna work for them.
So, you can write these prescriptions all day long. But if they tell you, you know, "I can't afford that" or "I can't remember that," "I can't get to the office to come get that shot," you're not going to help their control. So, we really want to tailor their treatments, not only to the type of asthma that they have, but what they think they can adhere to and stick with.
YOUNG: Right. I've been in working with asthma patients for a little over 15 years. And, you know, there hasn't been, I remember when omalizumab launched, you know, that was such a huge game changer for us in helping manage asthma patients. So what's the game changer for you in these particular types of patients?
HEFEL: Well, I just think it's been the explosion of new therapies that we've had recently. You know, we used to just have a few inhalers, montelukast, or a leukotriene receptor antagonist. We had our prednisone or theophylline way back when for your allergy shots. But now we have multiple inhaled therapies. Long-acting muscarinic agents are now approved for asthmatics. And we also have several types of biologics that we can offer. And some of these biologics actually can, treat some other conditions that are common in patients with asthma.
YOUNG: So again, being that little angel on the primary care shoulder, if you were to help them discuss your escalation process of asthma therapy, because your patient continues to have symptoms or exacerbate, how would, how would that look for them?
HEFEL: So our podcast today is about moderate to severe, so I'm gonna just focus on this type of treatment. So by now, this patient is, hopefully, already on a medium dose inhaled corticosteroid. But maybe, they've come to you and they've had several prednisone bursts or urgent care visits. And they're still having a lot of trouble with coughing or difficulty with exercise. That's where we need to step them up to step four therapy or a high-dose inhaled corticosteroid, or a long-acting beta agonist therapy. And we may even, at that point, consider adding a long-acting muscarinic agent like tiotropium or a leukotriene receptor antagonist.
For these patients, I think it's a good idea to see them. When you're changing therapy everywhere from 2 to 6 weeks until you finally stabilize them. If they're still not controlled at that point, that's really where the specialist comes in and can be helpful. So, many of the guidelines say once your patient is on step four or step five therapy, that's when they need to have a specialist be involved. So, we start working them up for their type of asthma by getting different blood levels, looking for eosinophils, looking for IgE, doing an allergy workup, if that's not already been done, testing their sputum for things like neutrophils or eosinophils, and giving them a phenotype, which can really help drive the treatment.
YOUNG: So, let's say this phenotype of patient is the allergic asthmatic, and we feel like that's really what's driving their asthma to be uncontrolled. They're on step four, step five therapy. They're basically maxed out on anything inhaled or oral that they can take. Let's talk a little bit about these biologic therapies, and when and where and how to start them.
HEFEL: So once you, once you have your phenotype, that's when you can start to look at these biologic therapies. So, we have five that have been approved for asthma here in the United States. The first one, which has been around the longest, and most people are probably most familiar with is omalizumab. So, this is an IgE-directed treatment. So IgE is an antibody that is produced by our immune system. And it's frequently increased in patients who have allergies, asthma, and can be significantly elevated in atopic dermatitis. So, the omalizumab was approved for use in severe persistent allergic asthmatics, ages 6 and over. It used to just be approved in our adult patients, but now we, we also have a pediatric indication. So, the dosing for the omalizumab, that's actually based on the patient's weight and their IgE level. So, some patients get therapy every two weeks, and some patients get it every four weeks. They do have to come into your office to get it, which, which can be a problem for some patients and then they also need to be prescribed epinephrine. There's a small risk for anaphylaxis with omalizumab, which is why it is given in a healthcare environment and why there are certain monitoring parameters after they receive their injection. Another condition that omalizumab is approved for is chronic idiopathic urticaria. So if you happen to have an asthmatic, who also gets hives all the time for a reason that you really can't explain, this may be the optimal treatment for them.
YOUNG: Kinda two birds with one stone there.
HEFEL: Yes. So the next category of biologics are the interleukin 5 biologics. So there's three that are out there for this. They are mepolizumab, which is every four weeks, given subcutaneously, rezlizumab, which is intravenous, every four weeks, and benralizumab, which can be given every eight weeks. So these biologics target interleukin 5 or IL5. They are labeled for use in severe eosinophilic asthma. The mepolizumab and the benralizumab could be given in a home setting, but the IV reslizumab would have to given at a healthcare setting. IL5 is a potent eosinophilic cytokine, so what that means is that it leads to the eosinophil differentiation, the maturation of the eosinophil in the bone marrow, as well as the activation of the eosinophils at the sites of allergic inflammation.
And the third category of biologic is the interleukin 4, interleukin 13 or IL4 and IL13. This is dupilumab. So dupilumab inhibits these two cytokines which leads to airway inflammation. And it's labeled for use in moderate to severe eosinophilic asthma or in oral corticosteroid- dependent asthma. So it's indicated for patients 12 and older, and it can be given at home every two weeks. So that might be a great option for some patients that maybe live in a rural setting, have a difficult time getting in to see a specialist, to get their biologic injection. One other thing about dupilumab that could be helpful for your patients is if your patient also has significant atopic dermatitis or eczema, it also has an indication for this in patients down to age six.
YOUNG: Ann, what's your expectation as far as the primary care role goes in asthma management? So, what things you want them to address and try to get done, uh, prior to a patient being referred, uh, to you?
HEFEL: So our primary care colleagues always do a wonderful job of addressing factors like adherence, trying to figure out ways to get their patients to stick with their medications, looking at their inhaler technique and assessing that periodically. And also addressing if they have any other comorbid conditions, getting them controlled in terms of weight management or gastroesophageal reflux disease. And then our hope is that they definitely stepped up their therapy, say, if they've just been on a short-acting beta agonist but still aren't controlled, getting them on an inhaled corticosteroid or an inhaled corticosteroid/LABA when appropriate.
YOUNG: Okay and when do you feel that the situation is prime for referral? When do they need to come see you?
HEFEL: So our guidelines and practice parameters do vary a little bit on this, but I don't think anyone in primary care should ever hesitate to send an asthmatic to either a pulmonologist or an asthma and allergy specialist. Anytime you are unsure about the diagnosis, so for example, they have terrible symptoms, they're getting frequent prednisone bursts, they're in the ER but you continue lung function testing on them and it always looks great, like a 25-year-old, then we would want to refer on for some additional specialized testing. Also when they're uncontrolled despite a medium dose or high dose inhaled corticosteroids/LABA, that's when we would definitely want to see them. If they've had intolerable side effects, so the usual asthma treatments, you've tried these, the patient just can't take them, you would like to refer to us to see if there are other treatment options. Perhaps they have severe allergies that are really poorly controlled and seem to related to their flareups, and then if they've ever been hospitalized or intubated for their asthma, that would be a good sign that we really should be involved in their care.
YOUNG: Yeah. I agree. I think it's never too early to send to a specialist. We would rather know them and see them, you know, before they're really a mess.And we'll take them at a mess too. I mean, I'll take all comers, but it's nice to see them before they're a mess. And my general rule to is two rounds of prednisone in 12 months, you know, that's a patient who definitely needs a little more aggressive management.
So speaking of steroids, let's touch a little bit on oral steroids. As we all know, there's no real one set recipe for treating patients with steroids, oral steroids, and in my practice, you know, if you were to question all of the physicians and nurse practitioners and PAs here, you probably would get a different dosing regime. So what advice would you give a primary care in their approach to oral steroid use in these patients?
HEFEL: Yeah so we're referring to GINA, the GINA guidelines, when they discuss oral steroid therapy for asthma exacerbations, they really recommend that we do 40 to 50 mg of prednisone for 5 to 7 days. Typically, I have those patients take it in the morning because it can lead to insomnia, although I have known providers to break up that dose and divide it into twice a day. And then if we're talking about children, we're doing it weekly, so we do one to two mg per kilo up to 40 mg for typically a slightly shorter duration, so anywhere from 3 to 5 days. And really there's a misconception out there that they have to taper, but you really don't have to taper those steroids if they're doing a course that's less than 14 days.
YOUNG: Mm-hmm. And unless the patient tells you they only do well with tapers, right? I have some patients who I try to give them a 5 or 7 day burst and they're like, "Oh God no, I have to taper." (Laughs) But psychologically makes them feel better, I tend to go with that. All right. So education of the patient is key, right? The more knowledge they have about this disease state, the more knowledge they have about why their symptoms are behaving the way they are, why they flare, those types of things. Definitely helps them get a little more control over their situation. So what sort of resources are out there for the patients and for the providers that maybe they're not quite aware of.
HEFEL: All of our organizations, so Chest, asthma.chestnet.org/patients, AAAAI, which is the American Academy of Allergy, Asthma, and Immunology, and the American College of Allergy, Asthma and Immunology. These are all some great evidence-based resources that you can trust, that you can refer your patients to. They have a variety of things both for healthcare professionals as well as your patients.
So if you're looking for, say you don't have time to go over inhaler technique with your patient in your office, you can give them the link to a video on how to properly take it. Also say you need an easy principal and free asthma action plan, these websites would have action plans that you can print off and you can stock in office, and there's a lot of good education materials for your patients that talk about how to control their triggers, how to manage their asthma, and I think that we all want to feel a little bit more in control of our health and helping the patients learn how they can do that and how they can best take care of themselves can go a long way.
YOUNG: What type of resources would you point primary cares to help them with trying to figure out, you know, is their patient's asthma controlled? Like what are your go to as far as...the things that you think are easily accessible for primary care to look at when they are seeing their asthma patient, to say I have this objective information to tell me this patient is likely controlled?
HEFEL: The two biggest things we typically use and we track over time would be their Asthma Control Test as well as their spirometry values. So if their lung function is going down over time, that's obviously concerning, or on the flip side, if it's starting to get better after you've initiated a change in treatment, you know that it's working. So we like to combine that along with the results of their asthma control tests to track them over time.
YOUNG: Thank you again Ann.I appreciate your knowledge and your time so much. The more I spend with you, the more I learn. I really appreciate it, and if you didn't get a chance to listen to our first podcast on utilizing add-on therapy for individualized treatment of asthma, you can go to PCE.is/asthma. Thank you also to PCE and Novartis for this opportunity to talk about asthma, and don't forget to get your CE units at PCE.is/asthma. Thank you guys.
HEFEL: Thank you.