"... and now I'm hoarse too"

Persons with asthma can have plenty of symptoms that they have to deal with, whether it’s shortness of breath, chest tightness, a noisy chest, or troublesome cough. At the same time nasal allergies can cause a stuffy or drippy nose, sneezing, or frequent throat clearing from post-nasal drip. And then we frequently hear about a hoarse voice. It often comes and goes and can be a considerable frustration, especially for those who do a lot of speaking in their work. The voice quality changes; people notice that your voice doesn’t sound the same, and sometimes it seems like more work to generate a normally loud voice. What is causing this problem on top of everything else?

There are a number of potential causes, just as in persons without asthma, such as trauma from repetitive coughing, gastroesophageal reflux disease (GERD) causing stomach acid to splash onto the vocal cords, or polyps forming along the vocal cords. But an important consideration in persons with asthma is hoarseness as a side effect from use of the medications, inhaled steroids. Examples include the inhaled steroids taken alone (Flovent, Pulmicort, Qvar, Asmanex, Alvesco, and Aerospan) as well as the inhaled steroids taken in combination with long-acting bronchodilator medicines (Advair, Symbicort, and Dulera).

You probably know that it is a good idea to rinse your mouth after using these inhalers in order to prevent a throat infection referred to as “thrush” or oral candidiasis, caused by the yeast, Candida. You cannot, however, rinse down to the level of your vocal cords, which sit behind your “Adam’s apple” in the middle of your neck. Some of the steroid medication that you are inhaling will settle on the vocal cords on its way down onto your bronchial tubes, with the possibility of causing irritation and voice weakness. This is an undesirable effect of the steroid medication – an “inhaled steroid-induced laryngitis.” It is more common when the medication is delivered by metered-dose inhaler rather than dry-powder inhaler, and it is probably more common when the dose of medication is higher. It occurs with all of the inhaled steroids, but not commonly with inhaled bronchodilators alone (such as albuterol), so it seems to be an effect of the medication, not the propellant or powder being inhaled.

No one knows exactly in what way the inhaled steroids affect the vocal cords to cause hoarseness. Some have thought that they cause a weakness of the muscles involved in bringing the cords together during speech; others have thought that there is irritation to the surface membrane that covers the cords. Occasionally, one can find candida infection of the vocal cords. The inhaled steroids do not cause throat cancer or permanent injury to the vocal cords.

Inhaled steroids are the cornerstone of long-term asthma treatment. They reduce symptoms, make the bronchial tubes less hypersensitive to the triggers of asthma, and help to prevent asthma attacks. Their increasingly widespread use is probably the reason for the reduction in asthma hospitalizations and deaths observed in the United States over the last 2 decades. Hoarseness is a frustrating side effect that affects some people who use these highly-effective medicines, even when they are doing everything right in their use.

What can be done? If you can safely omit use of your inhaled steroid for a period of time, your voice quality will return to normal. Sometimes it takes only a few days, sometimes a few weeks. You can try adding a spacer to your metered-dose inhaler or switching from a metered-dose inhaler to a dry-powder inhaler for delivery of your inhaled steroid. There is no good evidence that one inhaled steroid has fewer effects on the voice than any other, although there is some theoretic reasoning to suggest that ciclesonide (Alvesco) might cause less hoarseness. If your hoarseness is severe and persistent, it would be good to have a direct examination of the vocal cords performed by an otolaryngologist (ENT doctor), to exclude alternative reasons for your hoarseness. Meanwhile, we continue to seek better medicines to treat asthma -- effective and free of side effects.

E-cigarettes: smoking cessation aid or new addictive public health hazard?

“Vaping” is taking off in the U.S. and elsewhere around the world. With the encouragement of big tobacco companies, more and more people are trying electronic cigarettes as an alternative to tobacco-filled cigarettes. Should we be encouraged by the availability of a safe alternative to conventional cigarettes or dismayed by a new, addictive nicotine-containing product unleashed to the general public, including children, without regulatory oversight?

Why do we offer our opinion about e-cigarettes in a blog about asthma? We do so because: 1) many people with asthma smoke cigarettes, probably similar in frequency to the 19-20% of the general population who continue to smoke in the United States; and 2) we hate cigarette smoking! Our medical lives are filled to overflowing with smoking-related medical disasters, whether the slow suffocation of advanced emphysema or the horrible, inexorable death from incurable lung cancer (the cause of more cancer deaths in the United States than the next 3 most common cancer killers – colon, breast, and pancreas -- combined). Persons with asthma who smoke cigarettes put themselves in “double jeopardy,” with airway disease due to asthma combined with airway disease and emphysema due to cigarette smoking (chronic obstructive pulmonary disease or “COPD”), while at the same time interfering with the beneficial effects of some of the asthma medications (the inhaled steroids).

At first blush, then, we are inclined to embrace the idea of an alternative to cigarettes without the tar and other products of combustion that predispose to the development of cancer and other diseases, like heart attacks and strokes. As physicians, we are constantly seeking aids that can help persons who are addicted to cigarettes stop smoking. We have nicotine-containing patches, gum, nasal spray, and lozenges that we can recommend, even a small, nicotine-containing cartridge that can be placed in a plastic cigarette holder to inhale nicotine to the lungs (Nicotrol®). What’s wrong with a novel nicotine delivery system, the e-cigarette, which mimics smoking more closely, with a warm mist to inhale and a visible puff of smoke to enjoy “guilt-free?”

Well, here’s our list of what’s wrong with the e-cigarette:

• We don’t know exactly what is in the e-cigarette vapor. It contains nicotine, propylene glycol, often flavoring, and perhaps other chemicals. The amount of nicotine (and other chemicals) in each cartridge is not closely regulated. The long-term effects of inhaling this vapor into the lungs are unknown. Wouldn’t you like to know this information before promoting “vaping” as a safe alternative to cigarette smoking?

• One could imagine that widespread availability of e-cigarettes, aggressively marketed to children and young adults, could lead to an increase in persons addicted to nicotine and going on to take up cigarette smoking, rather than a decrease. We have witnessed over the last few decades a national change in attitude toward cigarette smoking, restricting smoking at work, in public places, in and around schools, restaurants, bars, airplanes, some hotels, etc. It is no longer the norm. What would the implication be of unrestricted use of e-cigarettes … at the workspace or restaurant table next to yours? What’s the risk of second-hand e-cigarette vapor exposure, anyway? We don’t know.

• Nicotine is highly addictive, even without all the other poisons in tobacco smoke. Do we as a nation need to offer inhaled nicotine as an unregulated drug, including to children, pregnant women, nursing mothers, persons with heart disease, and the elderly? Several countries around the world have banned the sale of e-cigarettes. Britain plans to regulate it as a medicine.

What should the U.S. Food and Drug Administration do, on our behalf?

We would favor making e-cigarettes available like the Nicotrol® inhalation system, with a prescription, to be used for the medical indication of smoking cessation. The FDA could closely monitor and control the contents of e-cigarettes and insist that the chemical components be clearly displayed on the product, like ingredients in a skin cream. The agency could also insist that medical studies be performed to ensure the short-term and long-term safety of the medication, or to develop clear labeling warnings about the potential health risks … as for other drugs. The manufacture and sale of e-cigarettes has already become a multi-billion dollar industry; there should be plenty of money to spare to do safety testing on the product, along with assessment of its effectiveness as a smoking-cessation aid.

The Forum of International Respiratory Societies, a consortium of professional respiratory societies and experts in respiratory medicine from around the world, recently released a position statement regarding electronic cigarettes. They recommended a ban on the sales of e-cigarettes; or if not a ban, regulation as medicines; or if not regulated as medicines, regulation as tobacco products. The publication is in press; an abstract is available at the following link: http://www.atsjournals.org/doi/abs/10.1164/rccm.201407-1198PP

Should We Bring Back Primatene Mist?

Imagine that you have been chosen to serve on a Food and Drug Administration (FDA) Advisory Panel that is being asked to review the application to approve a re-formulated Primatene Mist® for sale over-the-counter. Primatene Mist contains the bronchodilator, epinephrine. For decades it was available without a prescription, with many millions of inhalers sold. It was taken off the market at the end of 2011 because of the general ban on medications using the environmentally-harmful propellant, chlorofluorocarbons (CFCs). Primatene Mist has been redesigned now with the ozone-safe propellant, hyrdrofluoroalkanes (HFAs), and its manufacturer (Armstrong Pharmaceuticals) seeks to have it put back onto the shelves of pharmacies, markets, and convenience stores. How would you vote: “Yay” or “Nay”?

Let’s try to lay out the arguments, for and against approval. We recognize that there are many strongly held opinions on the topic, as a quick read of the “BringBackPrimateneMist” facebook page would suggest.

In favor of approval:
• Many people with asthma do not have a primary care provider to write for them prescription bronchodilators. They too need access to medication that can help their breathing, especially in an asthma crisis. This disparity of access to medication is especially pertinent to asthma, where the poor and minorities bear the greatest burden of the disease. Even some people with health insurance may find an over-the counter medication less expensive, and it can be purchased in a jam, when you discover that you have left your prescription bronchodilator at home.
• Epinephrine by metered-dose inhaler has been used by millions of people over more than 4 decades, suggesting its safety.
• Epinephrine is an effective bronchodilator that begins to work quickly (onset of effect within 1-2 minutes), though with a relatively short duration of effect (1-3 hours).

Against approval:
• Compared to newer (prescription) bronchodilator medications like albuterol (ProAir, Proventil, or Ventolin), epinephrine is more likely to cause heart racing and tremor.
• Selling a bronchodilator over-the-counter means that it can be obtained without medical guidance as to when, how often, and how much to use. Package labeling may carry this information, but more often than not it goes unread.
• An OTC medicine is available for purchase by children without medical or parental guidance.

Our take:
Primatene Mist sold over-the-counter perhaps made sense in an earlier era when our conception of asthma was a disease of bronchial muscle constriction. Take a bronchodilator medication that relaxes tightened bronchial muscles, open your narrowed airways, and all we be restored to normal. We now know better. Shortness of breath, cough, and wheezing are often due in large measure to allergic (or non-allergic) inflammation of the airways, with swelling of the airway walls and excess mucus production filling the bronchial tubes. Relying on a bronchial muscle relaxer to relieve symptoms leaves much of the cause of the problem untreated. By offering ready access to a medicine that treats only one aspect of asthmatic airway narrowing – temporarily – one invites insufficient treatment, delayed treatment, and the risk of more, not fewer, severe and dangerous asthmatic attacks. It is a step back in time for asthma treatment, not a well-reasoned advance forward. Why would one make an older, less effective bronchodilator available over-the-counter and restrict newer, safer, more effective bronchodilators to prescription only? Perhaps the way forward …in an attempt to make low-cost bronchodilators quickly available to persons who need them … is to make albuterol available over-the-counter in limited doses (for instance, in an inhaler with no more than 20 inhalations per device). The inhaler would provide enough doses to “buy time” while one seeks medical help, not so many that one relies solely on the bronchodilator medication and delays other crucial, potentially life-saving therapies. Of course, one could buy more than one such inhaler at a time, but the message would be clear: the bronchodilator inhaler is for short-term, quick-fix use only.

We recognize that this topic is controversial. Looking for allies to support our point of view, we have found the American Thoracic Society, the American College of Allergy, Asthma, and Immunology, and the American Association of Respiratory Care. We would note that the FDA Nonprescription Drugs Advisory Committee and the Pulmonary-Allergy Drugs Advisory Committee did meet to discuss Primatene Mist-HFA and voted in February against approval. The FDA has yet to make its final decision.

Our New Year's Asthma Wish List

Living with asthma can be full of frustrations and sometimes worse, imposing limitations and causing frightening flare-ups or “attacks.” We would like the asthma to just “go away,” so that at the top of our 2014 Wish List for asthma is finding a cure. And some days it feels as though we are getting closer – if not to a cure, at least to primary prevention. Interesting research into the low rates of asthma among children reared on small farms, brought up in close contact with farm animals and the detritus in their stalls, has led to speculation that introducing harmless germs into the environment of young children … the right germs in the right combination, at the right time, by the right route (ingested or inhaled?), in the right amount, and for the right duration … might lessen the risk of developing asthma. But short of eliminating asthma all together, here is our wish list – the “short list” -- for improvements in asthma care that we think are, or should be, within our grasp.

1. Low-cost, generic asthma medications. Ten years ago a generic albuterol inhaler was available without insurance coverage for less than $20. With the banning of inhaled medications using chlorofluorocarbon (CFC) propellants beginning in 2009, generic albuterol disappeared from sale, replaced by brand-name versions of albuterol with the hydrofluoroalkane (HFA) propellant, such as ProAir, Proventil, and Ventolin, all considerably more expensive. And despite their availability now for several decades, inhaled corticosteroids by metered-dose inhaler or dry-powder inhaler have never had a generic version available. It is true that generic albuterol and the inhaled steroid, budesonide, are available for nebulization, but it is not practical to ask all persons with asthma to administer their medications by nebulizer over 5-10 minutes for each dose, let alone carry a nebulizer with them at all times for emergency use. The Food and Drug Administration (FDA) should ease whatever restrictive regulations prevent release of generic albuterol-HFA and at least one generic inhaled corticosteroid, such as beclomethasone (first released in the United States in the early 1970s) or fluticasone (first released in the US more than 30 years ago).

2. Reduced medication side effects. On the bright side, most persons with asthma can achieve good asthma control (rare symptoms and freedom from asthma exacerbations) with currently available medications taken once or twice daily. Unfortunately, though generally well tolerated, these medications are not free of side effects. In particular, we are struck by how often our patients taking an inhaled medication that contains a corticosteroid complain of hoarse voice. Other side effects from the inhaled steroids include the risk of a yeast infection in the mouth (oral candidiasis or “thrush”) and, after many years of use at high doses, a slightly increased risk of cataracts, glaucoma, and loss of bone mass (osteoporosis). In growing children, slightly slowed vertical growth (ultimate height reduced on average by approximately 1/4-1/2 inch) is a concern. Although we can’t expect our medications to be entirely free of all undesirable effects, these are annoying side effects that sometimes limit use and are a worthy target for drug development or drug modification.

3. Identical health outcomes for people of color with asthma. More than twenty years ago epidemiologic studies identified the unequal distribution of asthma morbidity and mortality in the US. The rates of hospitalization and death due to asthma among African-Americans and Hispanics were 3-4 times greater than among whites. Now, after three releases of Guidelines for the Diagnosis and Management of Asthma by the National Heart, Lung, and Blood Institute of the National Institutes of Health to care providers throughout the US, the overall rates of hospitalization and death from asthma are decreasing, but racial and ethnic inequalities remain unchanged. In the US the color of one’s skin is a risk factor for dying from a severe asthma attack. Exactly why this injustice persists is uncertain, but it is likely that increased rates of poverty among persons of color play a major role. Addressing poverty and its link to poor asthma care is not an easy assignment, but it is not insurmountable. The work of Dr. Paul Farmer and Partners in Health in Haiti and elsewhere around the world should inspire our efforts in asthma care here in the US.

4. Novel therapies for severe, refractory asthma. Although most persons with asthma can achieve good asthma control with currently available medications, some cannot. It is estimated that as many as 20-25% of persons with asthma continue with frequent symptoms and multiple asthmatic attacks despite faithful use of strong, best-that-we-have asthma medications. Even if the true percentage were less, say 10%, that would mean that nearly two million Americans are in need of newer, more effective therapy for their asthma. Research is progressing in the development of novel medications for this subgroup of persons with “refractory” asthma. Designer molecules (called monoclonal antibodies) are being developed that will block the recruitment of allergy cells (eosinophils) to the bronchial tubes and inhibit powerful inflammation-stimulating molecules. Examples include monoclonal antibodies against interleukin 5 (mepolizumab and reslizumab), interleukin 13 (lebrikizumab), and the shared molecular receptor for interleukin-4 and 13 (dupilumab). Although the promise of these new biologic therapies is great, they are destined to be hugely expensive and require administration by injection or intravenous infusion. The search for alternative, simpler small molecular inhibitors of key biologic processes in asthma continues.

5. Preventing dangerous asthma attacks: “An app for that.” Despite our progress in treating asthma -- by targeting the underlying inflammation of the bronchial tubes as well as preventing spasm of the bronchial muscles that can tighten around our airways -- dangerous asthma attacks continue to occur. Nearly two million times a year persons with asthma rush to the emergency department of a hospital for treatment of asthma attacks. Sometimes these attacks develop gradually, as cough and chest tightness evolve into greater and greater breathlessness. Sometimes they catch us by surprise, lacking the usual warning signs; suddenly we are in a crisis, unable to breathe and desperately seeking quick relief. Even then, some of these sudden attacks may have had warning signals, if we had been able to perceive them. In general, narrowing of the breathing tubes comes on gradually, over hours to days, as swelling of the tubes develops, mucus forms, and the bronchial muscles tighten their grip. In this age of electronic self-monitoring, we need a smartphone app for tracking asthma and preventing early asthma attacks from progressing to such severity that they become life-threatening. There exist apps with fitness wristbands that track our activity level, calories burned, and even how much and how well we slept. Our New Year’s asthma wish list includes the asthma app that will sound the alarm to tell us when to take action because our asthma is getting out of control.

With our best wishes for a healthy and wheeze-free New Year!

"Can You Show Me How You Use Your Inhaler?"

This year a new type of delivery device for inhaled medications has become available. It is used to deliver the bronchodilators albuterol and ipratropium in combination (Combivent) and is called a “soft-mist” inhaler. With activation, a slow-moving mist of medication – somewhat like the aerosol from a nebulizer – is released for approximately 1½ seconds. A full dose of medication is contained within the mist, which is to be inhaled from the mouthpiece of the device. The soft mist inhaler joins a variety of other devices, including metered-dose inhalers, dry-powder inhalers, and hand-held nebulizers, used to deliver medications by inhalation. What strikes us as remarkable – and the subject of this blog -- is the daunting challenge faced by persons with asthma (and other lung diseases) as they try to master use of these very different inhaler devices. Some of the devices release a plume of medication traveling at high speed; others come in the form of a powder that is turned into an aerosol only by the force of a breath in. Some are best combined with a hollow chamber (“spacer”) that will hold the medicine in a confined space for a second or two prior to breathing it in; others cannot be combined with a spacer. Some medications come in more than one form – metered-dose inhaler and liquid for nebulizer; metered-dose inhaler and dry-powder inhaler – although most do not.

What we wish to share in this blog is the way that we teach inhaler use. As part of the “package insert,” each device comes with instructions that describe the steps involved in preparing and then inhaling the specific medication, and many companies provide additional printed hand-outs, often in multiple languages. In addition, video instructions are often available on-line. Nonetheless, in our opinion, there is no substitute for live demonstration in the office. It takes no more than a minute, it can be repeated as often as necessary, reading skills and internet access are not required, and there is no charge or adverse side-effect! If available, a placebo demonstration device is very useful; otherwise, role play also works well.

Here’s what we say for metered-dose inhalers: shake the medicine one or two times; with the device held upright (mouthpiece at the bottom), put the mouthpiece between lips and teeth and seal your lips around it. To release the medicine, depress and then release the canister in its plastic holder held between thumb and index finger; and then immediately take a slow, deep breath in. Slow and deep allow the medication to enter deep into the lungs (instead of impacting on the back of the throat) and to deposit onto hundreds of bronchial tubes, large and small. A slow, steady breath over 4-5 seconds should do the trick. Then hold your breath for a few seconds before exhaling, to prevent losing much of the medication in the exhaled air.

In our experience, the “slow and deep breath in and then hold your breath a bit” are the parts most often omitted. We all find ourselves too busy, in too much of a hurry, too focused on other things to concentrate on the act of properly using our inhalers. And yet it makes a difference, often a big difference. The difference between poorly-controlled asthma and well-controlled asthma can at times be a matter of properly inhaling one’s current medications, rather than escalating the dose of medicine or changing from one medicine to another.

A spacer can be used with metered-dose inhalers and helps to relieve the “stress” of getting exactly the right timing between squirting the medication from the device and immediately beginning to breathe in. By releasing the medication into the confined volume of the spacer, one can then, stepwise, breathe in only after the medication is where you want it, waiting to be pulled from the chamber into the lungs. Still, the subsequent steps are key, as before: slow and deep breath in and hold your breath for perhaps 5 seconds. Besides helping with the timing of hand-breath coordination, the spacer reduces the amount of medication that would otherwise settle on your tongue and throat. For steroid medications like flucticasone (Flovent), this means less steroid available to be swallowed and absorbed from your stomach into the rest of your body. If you are well-skilled in using your quick-relief bronchodilator inhaler such as albuterol (Proair, Proventil, or Ventolin), then you need not tack on a spacer. If you have trouble coordinating your inhaler – and, in the case of steroids, to reduce the amount of steroids settling on your mouth and throat -- the spacer is a useful addition.

No plume of medication is released from dry-powder inhalers. With the force of one’s breath in, one turns the collection of powder in the inhaler into an aerosol that can be breathed deep into the lungs. Each device is prepared for the next dose of medication in a slightly different way, but when the medication is ready to be released, the process is the same: seal your lips around the mouthpiece, take in a strong breath to pull the medication out of the device, continue a long and deep breath in to distribute the medication widely throughout the lungs, and then hold your breath for a few seconds before exhaling. Again, the long and deep and then hold your breath steps are the ones that we want to emphasize. A short, quick gasp puts medicine primarily on your uvula and windpipe without getting it far out onto the bronchial tubes where it is needed. Spacers cannot be used with dry-powder inhalers (including those that deliver steroid medication).

We recognize that many other things get in the way of our taking medications regularly for a chronic condition. An article in The New York Times recently highlighted the issue of exorbitant medication costs. And there are many other obstacles to adherence to the medical provider’s prescription: dislike of medication side-effects; concerns about long-term medication safety; fears of medication dependence or loss of potency over time; confusion when choosing among different inhalers; and forgetfulness, to name a few. It is estimated that daily use of an inhaled steroid for asthma among those prescribed a steroid inhaler for daily use is 40% or less. Still, we believe that one of the reasons for not taking your preventive inhaler and getting the most out of it should not be: “my doctor never showed how I was supposed to use it.”

Intermittent Use of Inhaled Steroids for Mild Asthma

For decades now, guidelines for asthma care have recommended that persons with persistent asthma should take daily anti-inflammatory medication, preferably an inhaled steroid, to lessen their symptoms of asthma and reduce the frequency of flare-ups of their disease (asthma “attacks”).  At the same time, it has been suggested that persons who have very mild disease and few symptoms (“intermittent asthma”) can use their quick-relief bronchodilator as needed and need no other medication for their asthma.  Inhaled steroids have not been recommended for persons with mild and intermittent asthma because: 1) infrequent symptoms do not seem to warrant daily medication, and 2) evidence indicates that long-term use of inhaled steroids does not improve lung function over time or affect long-term outcomes in asthma.

Panels of experts write the asthma guidelines based on their experience and available scientific information.  (The guidelines are not divinely inspired or carved in stone tablets!)  Asked to define “persistent asthma,” the experts reached the following consensus: anyone who has two days or more of asthma symptoms each week or wakes up two or more times with asthma symptoms each month or has lung function that is below normal or has had two or more attacks of asthma (requiring oral steroids) in the past year.  Taken as a whole, patients with persistent asthma who are treated with regular (daily) inhaled steroids have fewer symptoms of their asthma, less need for their “rescue” bronchodilator, better lung function, fewer asthma attacks, and an overall improved sense of well-being. 

But a fair question – and one that has now been addressed by recent clinical research – is exactly where one should draw the line between “intermittent” and “persistent” asthma.  Did the experts get it right, or are there patients with persistent (as defined above) but mild asthma who do not in fact need to take an anti-inflammatory medication daily for relief of symptoms and prevention of asthmatic attacks?  If you have mild persistent asthma and your symptoms are sufficiently few (more than two days out of the week but less than every day), prior asthma attacks have been sufficiently rare, and breathing tests are for the most part normal, might you take inhaled steroids only during periods when your asthma is troublesome but stop them during times when your asthma is no longer bothering you?  It is very likely that many patients with asthma have been following this practice for years – because daily medication use can be onerous – but is it safe and advisable?

Two studies – one in adults [Boushey et al., New England Journal of Medicine 2005; 352:1519] and one in young children [Zeiger et al., New England Journal of Medicine 2011; 365:1990]  – have indicated that the strategy of using inhaled steroids intermittently, only during periods of increased symptoms, is indeed safe for persons with mild persistent asthma.  These studies found that among persons with mild persistent asthma there was no difference in the frequency of asthma attacks, including severe or dangerous attacks, and very little overall difference in sense of well-being whether they used their inhaled steroids every day vs. used them only when symptoms became troublesome … as long as everyone had a plan regarding how to deal with an asthma attack. 

Let’s be specific.  Based on these recent studies, if your asthma has been mild, your medical provider might prescribe for you an albuterol (ProAir, Proventil, or Ventolin) or levalbuterol (Xopenex) inhaler to use whenever you need it.  If you find yourself using your quick-relief bronchodilator a lot, or if you feel congested at the start of a “cold,” or if you are visiting your in-laws who own a cat to which you are allergic, you would begin your steroid inhaler, such as fluticasone (Flovent), budesonide (Pulmicort), beclomethasone (Qvar), mometasone (Asmanex), or ciclesonide (Alvesco).  You would probably take at least four inhalations morning and night every day for approximately ten days, and then when you felt better, didn’t need your rescue bronchodilator so often, had gotten over the cold, or were no longer exposed to the pet cat, stop your steroid inhaler.  And you would be prepared with the knowledge that if your symptoms worsened despite taking the inhaled steroid, you would need to begin oral steroids (e.g., prednisone or Medrol) and be in contact with your healthcare provider.

Two important caveats before one puts this approach into practice.  First, it is not intended for persons with more severe forms of asthma.  Our emergency departments routinely treat persons with asthma who had been doing well until they stopped taking their preventive asthma medication (their inhaled steroids), thinking that they no longer needed them, and then developed severe asthma symptoms.  In persons with moderate and severe persistent asthma, evidence is unequivocal that reducing the dose and then stopping inhaled steroids is associated with more asthma attacks and worse asthma control.  Second, intermittent use of inhaled steroids does not mean “as needed” or “p.r.n.”  For this new strategy to work, the inhaled steroids need to be taken not here and there trying to relieve symptoms but every day, usually twice a day, for a period of 1-2 weeks or more.  Intermittent use of inhaled steroids refers to regular, daily administration, but for a limited period of time rather than year-round indefinitely.

In the future, another group of national and international asthma experts will write an updated set of asthma guidelines and render its opinion regarding this approach to asthma care.  In the meantime, our opinion is that this is a safe and reasonable way to treat mild asthma.  It is not appropriate for persons whose asthma is more severe, and its implementation requires careful explanation and reinforcement such that everyone is clear as to when to begin the inhaled steroids, how to use them and for how long, and what to do if asthma fails to improve as expected.

A Steroid "Burst"

We recently received an e-mail from overseas commenting that a steroid “burst” does not translate well.  It sounds too violent, like an explosion.  Now that we think about it, a steroid “burst” does sound like something one might see at a Fourth of July fireworks display!  But you know what we are referring to: that time-limited course of prednisone or methylprednisolone (Medrol) taken by mouth to quiet a flare of out-of-control asthma.  Most persons with asthma have a love-hate relationship with oral steroids.  Love: the medicine helps you breathe normally again, “better than ever,” at a time when your other medications seemed no longer to work.  Hate: it often has unpleasant side-effects, such as stomach discomfort, moodiness, agitation, sleeplessness, and, of course, the “hungry horrors.”

What may have struck you … as it does us … is that no one seems to know the exactly “right” way to prescribe a steroid “burst.”  Sometimes you are given 40 mg of prednisone to start, sometimes 60 mg.  If you went to the Emergency Department to receive your first dose, it may have been given intravenously at twice the amount, as methylprednisolone (Solu-Medrol) 125 mg.  After the first dose you may have been given 5 days of treatment, 14 days, or longer.  And the dose may have been reduced from its initial large amount to zero in various ways – by 10 mg/day every day or every two days, by 20 mg every 4 days, by inclusion of the low dose of 5 mg/day or not, etc.  Or perhaps your doctor likes the Medrol dose-pack, a pre-programmed 6-day tapering schedule in a package of tablets clearly laid out with each day’s decreasing dose.  And most recently you may have been sent home with 50 mg/day for 5 days, then stop.  No taper to off, just stop

As you might surmise, such a variety of approaches reflects lack of scientific knowledge.  The best way to prescribe a short course of oral steroids has not been carefully studied in scientific trials, and it may be that there is no one “right way” to use steroids.  Some people and some exacerbations of asthma may require more medicine for longer periods of time, others may do well with less medicine for shorter duration.  A recent experiment among more than 300 people with chronic obstructive pulmonary disease (COPD, the chronic obstructive lung disease of cigarette smokers) found that 5 days of prednisone at 40 mg/day was as effective as a two-week course of treatment [Leuppi, et al., Journal of the American Medical Association 2013; 309:2223-31], but COPD is not asthma.  It is uncertain whether the same outcome would hold true among persons experiencing flare-ups of their asthma.

What we do know may surprise you.  Despite the time-honored approach of reducing the dose of prednisone in stepwise decreases – the “steroid taper” -- research has shown that abrupt discontinuation of oral steroids achieves the same asthma control and prevention of recurrences as a slow steroid taper, as long as after the oral steroids you continue preventive treatment with inhaled steroids.  When used for a brief period (fewer than 2-3 weeks), there is no medical reason that the dose of oral steroids has to be slowly decreased.  It is o.k. to reduce the dose in stepwise fashion, but it is not necessary for biologic reasons.

In the absence of scientific data, we are free to share with you what we think is a reasonable general approach, acknowledging that other recommendations may someday be found to be just as good or even better (in which case we will change our approach!).   During a severe asthma flare-up we begin with prednisone between 40 and 60 mg/day (40 mg/day for smaller people, 60 mg/day for larger people).  The tablets can be taken altogether in a single, once-a-day dose.  It then makes most sense to continue treatment at this dose until you are all better or almost all better (as guided by your symptoms or, even better, by finding that your measured peak flow has returned back to its usual value when you are well), and then stop the prednisone or quickly reduce the dose to zero over a few days.  Typically, your medical provider will make a guess as to how long it will take for you to recover from your asthma attack and prescribe a specific duration of treatment.  A severe asthma flare usually abates with treatment over 1-2 weeks; milder attacks resolve more quickly.  Sometimes your provider will allow you to adjust the duration of treatment on your own according to your response to it.  Once you are better, we anticipate that you will continue to feel well and maintain good lung function if you continue taking your inhaled steroid and, where possible, avoid the triggers that set off your asthma attack in the first place.