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This article originally appeared in the March-April 2003 FDA Consumer and contains revisions made in March 2003 and May 2004.
To a Friend
By Michelle Meadows
During the mid-1980s, Sandra Fusco-Walker's life was filled with sleepless nights, ruined vacations, emergency room visits, and her children's frequent school absences. Two of her three children--all under age 6 at the time--had asthma.
"I was always worried about when the next bad thing would happen," says the Kinnelon, N.J., resident. "But that was before we had a plan."
The "plan" was an asthma action plan that guided her on how to track her children's symptoms, monitor their breathing, and give them medication. "A plan tells you what to do and when," she says. "Without it, asthma is out of control, and that's when the disease wreaks havoc on your life."
Asthma causes the airways to be inflamed or swollen, and the surrounding muscles are tight. When people with asthma react to various triggers, such as dust, pollen or smoke, their airways become narrow, which causes labored breathing, wheezing, chest tightness, or coughing. About 15 million people in the United States have asthma and almost 5 million are children, according to the National Heart, Lung, and Blood Institute (NHLBI). Every year, asthma causes roughly 2 million emergency room visits, up to 500,000 hospitalizations, and 4,500 deaths.
Fusco-Walker says she learned to control asthma after she followed her doctor's advice and called a nonprofit organization called Allergy & Asthma Network Mothers of Asthmatics (AANMA). The woman who answered the phone was Nancy Sander, who founded the organization in 1985 after facing challenges in dealing with her own daughter's asthma. Fusco-Walker says, "Nancy assured me that I wasn't going crazy."
With support and advice from AANMA, Fusco-Walker learned to look for patterns in her children's illness. For example, her kids got sick every time they visited her mother, and her mother smoked. Her oldest daughter had an asthma attack when she visited their horse barn. Fusco-Walker also learned to spot early warning signs of trouble. "I noticed that one of my daughters rubbed her nose when breathing became difficult," she says. "If I saw her rubbing her nose, I knew to get the peak flow meter." A peak flow meter is a small tool that measures how fast air moves out of the airways. Fusco-Walker attributes the success of her asthma action plan to the regular use of a peak flow meter.
By the time Fusco-Walker's youngest child was diagnosed with asthma at age 5, her family had a much better understanding of the disease. Shannon, who is now 16, Jared, 19, and Morgan, 21, grew up learning how to use their asthma medicine. "They know when to use their inhalers, they know when they need refills, and they know when they need to take medication before doing an activity," she says. They also grew up participating in just about any activity they wanted to, including football, swimming, soccer, and snowboarding.
Experts say most people with asthma can live a normal, active life. What it takes is avoiding the triggers that make your asthma worse, keeping track of your symptoms, and sticking to an effective treatment regimen. Many people with asthma need short-term medicine for when they experience symptoms, and also long-term daily medicine that reduces inflammation in the airways and helps prevent asthma attacks.
"I'll hear people say they skipped their medication because they haven't been coughing that much," says Richard L. Wasserman, M.D., Ph.D., clinical associate professor of pediatrics at the University of Texas Southwestern Medical School. "But I tell them they probably wouldn't have coughed at all if they kept to the regimen." He says it's important to understand that asthma is a chronic inflammatory lung disease. "Like high blood pressure, asthma is there all the time even when there are no symptoms."
The first step in controlling asthma is an accurate diagnosis. Fusco-Walker says doctors diagnosed her kids with all kinds of illnesses before she knew the problem was asthma. According to Kathleen Sheerin, M.D., an asthma specialist with the Atlanta Allergy and Asthma Clinic, this is a common problem, and both consumers and doctors play a role. "Some people are scared of the word 'asthma' because they only think of an emergency room scene on TV," she says. "I tell them there are a whole range of asthma symptoms, and the disease doesn't have to be scary if it's properly managed."
Sheerin says, "Doctors may call asthma other things like wheezy bronchitis or reactive airway disease." Asthma symptoms vary by individual, and the disease can look like other lung diseases. Also, asthma symptoms usually surface before age 6, but it can be difficult to establish a firm diagnosis in young children. "Babies up to age 2 or 3 may wheeze only when they get a cold, and we call them 'transient wheezers,'" Sheerin says. "For other kids, the wheezing continues as they grow." These children, often considered "persistent wheezers," have chronic asthma. (Also see "What Causes Asthma?")
"What we do is look for factors that make it more likely that a child's asthma will persist," Sheerin says. These factors include having a family history of asthma. Asthma is also more likely to persist if symptoms aren't only associated with a cold, but if there are also symptoms associated with other triggers such as smoke. People with asthma that persists also tend to experience wheezing that occurs at night, with exercise, or with seasonal changes. They also may have other allergic symptoms, such as allergic rhinitis or eczema, an itchy skin condition.
Sheerin participates in a state education program called Breathe Georgia, which uses the slogan "Call it what it is" to encourage doctors to accurately diagnose asthma. "You have to know that you have it in order to understand it and manage it," she says. "And an earlier diagnosis usually means better health outcomes."
The older someone is, the easier asthma is to diagnose. Doctors rely on a combination of a medical history, response to medications, and lung function tests. Such tests are generally hard to use in children under 6. One common lung function test, spirometry, involves inhaling and exhaling through a tube for several seconds. In some cases, allergy tests are performed to help determine asthma triggers.
Doctors determine whether asthma is intermittent (occurring from time to time), or persistent, defined as having symptoms at least twice a week during the day or twice a month during the night. Asthma that is considered persistent is further categorized as mild, moderate or severe. Fusco-Walker, who was diagnosed with mild asthma in her thirties, says these categories help doctors determine an appropriate treatment plan. "But remember that regardless of the type, you still have asthma and it is still a life-threatening illness," she says. "Some people hear the word 'mild' and think they don't have to worry about it. But they do."
Though asthma can't be cured, it typically can be treated, and scientists are currently studying whether untreated asthma causes a permanent change in the airways. As a natural part of aging, we begin losing lung function in our twenties. Untreated asthma might further accelerate that loss.
Brian Thomas, 41, a book distributor in New York City, has childhood memories of vaporizers by the side of his bed. "I remember wheezing the night away, often with my mother sitting with me," he says. He noticed some relief from asthma symptoms when he went off to college in Syracuse, N.Y. But the symptoms returned whenever he came home to his childhood bedroom. The culprits were dust mites, tiny bugs that are too small to see. They live on mattresses, bed linens, carpet, and stuffed animals. When Thomas' parents removed the carpet from his room, his asthma symptoms improved considerably.
In people with asthma, inflamed airways
react to triggers such as smoke, dust, or pollen. The airways become narrow,
making it difficult to breathe.
He went about 10 years without problems, but after a bad cold in 1989, he began wheezing and using an inhaler as needed. In 1990, Thomas had the worst asthma attack of his life when his roommates began building an addition to their New York apartment. "They were doing a lot of woodwork, and I noticed some wheezing," Thomas says. "I thought I had it under control with my inhaler." Then his roommates painted, and that's when things got much worse.
"My chest felt tight and burned, and I just couldn't catch my breath," he says. Luckily, his landlord got a cab to take him to the emergency room at Beth Israel Hospital, and doctors were able to quickly get Thomas' asthma under control. But it was the longest cab ride of his life. "I thought I would die right there on the bridge" that connects the Williamsburg section of Brooklyn to the Lower East Side of Manhattan.
Common asthma triggers include dust, pollen, cockroaches, cold air, smoke, and other strong odors, such as paint, cleaning fluids, perfume, hair spray, and powder. For some people, the problem is animal dander, flakes of skin and dried saliva from furry or feathered animals. For others, asthma can be triggered by medication, such as aspirin, or sulfites, preservatives used in food.
Stress is thought to be a trigger of asthma. Stress can create strong physiologic reactions that lead to airway constriction. Stress can also alter the immune system, which can, in turn, increase the likelihood of an asthma attack in people with asthma. According to the Centers for Disease Control and Prevention (CDC), after the Sept. 11, 2001, attacks on the World Trade Center, some adults in Manhattan reported an increase in their asthma symptoms due to stress, as well as from smoke and debris.
It's not always possible to avoid triggers, but experts suggest that you can track what causes problems and limit exposure as much as possible. Also, talk with your doctor about preventive steps you can take. When Thomas cleans up, for example, he wears a dust mask, available at many hardware stores. To get rid of dust mites, you can encase pillows and mattresses in dust-proof covers and wash bed linens and stuffed animals in hot water each week.
The NHLBI recommends keeping furry and feathered pets out of the home, or at least out of bedrooms, if pets are known to trigger asthma symptoms. Recent research, however, suggests that children with high exposure to cat allergens early in life develop an immune response to cats, reducing the risk for asthma. In the study, published in the March 10, 2001, issue of The Lancet, Thomas Platts-Mills and colleagues at the University of Virginia found that exposure to cats may be protective for some kids but a risk factor for others. The research suggests you might not have to get rid of your cat when the baby comes, but if you or your child experience asthma symptoms because of the cat, the cat should go.
Consult with a doctor about when or how much to increase medications as a preventive measure, such as before allergy season starts or if you're traveling to a place where it may be impossible to know what you will encounter in the way of pollution or environmental allergens.
There are two main categories of asthma drugs: short-term, quick-relief medications that relieve asthma symptoms, and long-term controller medications that are used every day by people with persistent asthma, even when they feel fine.
Wasserman, who works with The Dallas Asthma Consortium, says the organization advises consumers with "The Rules of Two": If you take your quick-relief inhaler more than two times a week, if you wake up with asthma more than two times a month, or if you refill your quick-relief inhaler more than two times a year, the group recommends that two medicines for asthma are needed and that you should talk with your doctor about a long-term controller.
Short-term reliever medication refers to short-acting inhaled beta-2 agonists such as albuterol and pirbuterol. Beta-2 agonists, also known as bronchodilators, relax the muscles surrounding the airways. In addition, systemic corticosteroids, such as prednisone and prednisolone, are drugs that help relieve the inflammation or swelling in the airway. Taken in tablet or syrup form, they are often used to treat severe asthma attacks.
As for long-term controller medication, inhaled corticosteroids are the most consistently effective. Other long-term controller medications include long-acting beta-agonists, which are used in addition to inhaled steroids. Examples of long-acting beta-agonists are salmeterol and formoterol. (For recent news about salmeterol, see "Safety Study on Serevent.") Cromolyn sodium, nedocromil, and methylxanthines are also in the controller anti-inflammatory category. Another class of long-term controller drugs is called anti-leukotriene medication, and examples include Singulair (montelukast) and Accolate (zafirlukast). These drugs block the action of chemicals called leukotrienes, which are involved in the development of asthma.
In June 2003, the FDA approved Xolair (omalizumab), the first biotechnology product to treat people 12 years and older who have moderate-to-severe allergy-related asthma. The product, which is given as an injection under the skin, is a second-line treatment, recommended only after first-line treatments have failed.
National guidelines on managing asthma now recommend that inhaled corticosteroids are the preferred first-line treatment for people of all ages with persistent asthma. (See "NIH Updates Asthma Guidelines.") Developed by an expert panel of the National Asthma Education and Prevention Program (NAEPP), the guidelines also recommend that if inhaled corticosteroids are not achieving optimal control, dual-control therapy should be used. "We're advising doctors that if inhaled corticosteroids are not proving effective, before increasing the dose, add a long-acting beta-2 agonist," says James Kiley, Ph.D., director of the Division of Lung Diseases at the NHLBI.
Badrul Chowdhury, M.D., Ph.D., acting director of the FDA's Division of Pulmonary and Allergy Drug Products, says significant advances in asthma drugs include the approval of Advair (fluticasone and salmeterol) in 2000. "This drug might improve adherence because you don't have to go between two drugs," Chowdhury says. It's the first drug approved by the FDA that combines an inhaled corticosteroid and a long-acting bronchodilator in one device, which has a built-in counter that tracks the number of doses. Chowdhury says also significant is the recent FDA approval of the inhaled corticosteroid Pulmicort (budesonide) for children as young as 1 and the approval of Xolair (omalizmab) in 2003.
Thomas says he felt lucky to survive his bad asthma attack in New York, but the experience was so traumatic that he took a month off work and went back home to his parents' house to recover. "I had panic attacks and a lot of anxiety about having another attack," he says. His anxiety level eased as he got a better handle on monitoring and preventing symptoms and using medicine.
Thomas has gone for 10 years without a major asthma attack, and he attributes that to several factors. He uses a daily long-term inhaled corticosteroid called Azmacort (triamcinolone acetonide) to relieve the inflammation that can cause an asthma attack, and he uses a Ventolin (albuterol) inhaler as needed for short-term quick relief of acute symptoms. He says that in the weeks before his bad asthma attack, he was using a quick-relief inhaler several times a day, even sometimes several times in the same hour. He now recognizes such use as a sign of trouble.
Thomas avoids known triggers and monitors his breathing with a peak flow meter. "As a kid, I just dealt with the asthma attacks as they happened," he says. "Now, I pay attention to what's going on before it gets bad."
According to the NAEPP Expert Panel Report, peak flow meters may be most helpful for people with moderate or severe asthma. A meter reading will tell you your peak flow zones, which are based on the colors of a traffic light. The green zone signals that your asthma is in good control, the yellow zone signals caution and is a sign to use quick-relief medicine to relieve symptoms, and the red zone signals a medical alert that means you should contact a doctor. Written plans can be useful for telling you what kind of medicine to take and how much to take when you're in each zone.
Inhaled asthma medications are delivered through many different devices, including metered dose inhalers, dry powder inhalers, and nebulizers. It's important to get instructions on how to use each medicine you take, and to have your doctor or nurse check your technique. To improve effective use of medication for kids or adults, plastic devices called spacers are often used with inhalers. Spacers create a space between the inhaler and the person's mouth to help more medicine get into the lungs. A nebulizer, which delivers medicine in a fine mist, also is useful for young children.
The issue of using asthma medications in school remains a challenging area for children and parents. To date, 18 states have laws or policies allowing children to carry inhalers in schools, according to AANMA. Many schools require an inhaler to be kept in the nurse's office because it's a drug. "But if a child is in gym class and the nurse is three buildings away, that could be a problem," says Sheerin, the asthma specialist in Atlanta. Experts say the two best things we can do for children with asthma are to teach them how to manage their asthma as they grow up, and to share a written plan from your doctor with the school.
Fusco-Walker, who now works with AANMA as an educator, points to the American Lung Association's asthma camp program as a good support system for parents of children with asthma. "It's a great place for children to learn how to manage their asthma, and parents can enjoy peace of mind while their children experience summer camp," she says. Kids participate in regular camp activities like swimming and biking, and there are trained medical personnel who teach the kids proper use of medication and other aspects of asthma management.
Sheerin says all kids should be able to sleep, play and learn. "If parents are up at night, if kids can't play, or if they are missing a lot of school because of asthma, then the asthma management plan is not right."
When it comes to managing asthma, adherence has two parts. "The first is that doctors use the guidelines on asthma management, and the second is that people with asthma follow their plans," says William Busse, M.D., professor of medicine in allergy and immunology at the University of Wisconsin Medical School. Busse is also chairman of the National Asthma Education and Prevention Program Expert Panel, which updated the Guidelines for the Diagnosis and Management of Asthma in June 2002.
Targeted to doctors, these guidelines were first published in 1991 and then revised in 1997. An update in June 2002 reflects scientific advances over the last five years. Here are highlights from the most recent update:
Inhaled corticosteroids, which treat chronic inflammation of the airways, are safe, effective, and preferred first-line therapy for children and adults with persistent asthma.
Inhaled corticosteroids are safe at recommended dosages. There has been concern about slowed growth in children due to use of inhaled corticosteroids. Research shows that this potential risk is temporary and possibly reversible. Nonetheless, doctors should monitor children's growth while giving inhaled corticosteroids, because slowing of growth is a good marker for side effects in other organs in the body. The expert panel also found that other concerns associated with use of corticosteroids, such as reduced bone mineral density, suppressed adrenal function, and increased risk of cataracts, are not considered significant risks for children. The risk-benefit assessment favors the use of inhaled corticosteroids for the treatment of persistent asthma.
When inhaled corticosteroids are not achieving optimal effectiveness, doctors should add a long-acting beta-2 agonist. These types of drugs, also known as bronchodilators, relax the muscles surrounding the airways.
Black Americans have only a slightly higher prevalence rate of asthma than whites (8.5 percent versus 7.1 percent), but blacks are three times more likely to die or be hospitalized because of the disease. According to the Centers for Disease Control and Prevention, while asthma mortality rates have gone down overall since 1995, racial disparities remain.
Floyd Malveaux, M.D., dean of Howard University's College of Medicine in Washington, D.C., says the reasons are complex. "We know that this is one of many diseases in which minorities and underserved populations are disproportionately affected," he says. "A lot of the disparities are related to poverty."
Malveaux says lack of access to care plays a large role. "It's not just about having health insurance," he says, "but also about whether there is access to transportation and knowing how to use the health care system. There may be no access to asthma specialists, perhaps because of limitations in managed care. So then what you have is a reactive situation and a lot of emergency room visits versus a proactive situation that focuses on prevention."
He also points out that when you're living in poverty you can't control the environment like you may want to. "I think of an area in Detroit where big diesel trucks come across from Canada," he says. "You can see the line of trucks emitting diesel fuel in a poor neighborhood, and the people who live there can't control that."
Other factors may be the challenge of paying for asthma medications and exposure to smoking and cockroaches. Research supported by the National Institute of Allergy and Infectious Diseases has found that children in inner-city areas who were both allergic to cockroaches and heavily exposed to them had higher rates of hospitalization for asthma, missed school more often, and suffered more sleep loss.
Hispanics also have higher death rates from asthma compared with whites, with Puerto Ricans experiencing the highest burden.
Inflammation (swelling) of the airways is the underlying cause of asthma, and there are two main reasons that people develop the disease, says Fernando Martinez, M.D., director of the Arizona Respiratory Center at the University of Arizona College of Medicine in Tucson. "Some people develop asthma because they react to viral infections like the common cold. Another group is genetically predisposed to it, and for them, asthma is associated with the way the lungs grow and the way the immune system develops." It is in this second group that asthma tends to be persistent, and there is often a family history of asthma and allergies. "Over the next decade," Martinez says, "determining which genes are involved will help scientists prevent and treat the disease."
William Busse, M.D., professor of medicine in allergy and immunology at the University of Wisconsin Medical School, says the causes of the increasing asthma rates are not fully understood. He says that the prevalence of asthma is higher in developed countries, such as the United States, Europe, and New Zealand, and is lower in less developed areas, such as China and Africa. This suggests a possible role of environmental or lifestyle factors that may affect the type and magnitude of exposure to environmental allergens and immune response to that exposure. Researchers are exploring possible factors such as diet, frequent use of antibiotics, and fewer and less severe infections in early life. Busse says studies have shown that children who are enrolled in day care before 6 months of age have more frequent infections in early life, but significantly less asthma after age 6.
Asthma also occurs more in urban environments than in farming ones. The Hygiene Hypothesis, first proposed in 1989, remains under debate and requires further study, according to Busse. This hypothesis states that environments that are too clean may actually make immune function more likely to develop allergic responses. In a study published in the Sept. 19, 2002, issue of The New England Journal of Medicine, researchers studied 812 children ages 6 to 13 living in rural areas of Germany, Austria, and Switzerland, and found that children in farming households experienced a decreased risk of hay fever and asthma.
In January 2003, the FDA announced that an interim analysis of a large safety study of the asthma drug Serevent (salmeterol) Inhalation Aerosol suggests that the drug may be associated with an increased risk of life-threatening asthma episodes or asthma-related deaths. Further analyses of the data suggest that the risk might be greater in blacks. Also, people not taking inhaled corticosteroids when they entered the study appeared to have greater risk for serious outcomes than those who were taking inhaled corticosteroids.
Serevent Inhalation Aerosol belongs to the class of asthma medications known as beta-2 receptor agonists, commonly called beta-agonists. The FDA approved the drug in 1994 to treat asthma, and approval was later extended for treatment of chronic obstructive pulmonary disease (COPD).
The safety study began in 1996 after the FDA received reports of several asthma deaths associated with the use of Serevent Inhalation Aerosol, and after studies raised concern about the regular use of short-acting and long-acting beta-agonists.
Because people with asthma can sometimes suffer sudden, serious life-threatening episodes of bronchospasm, the deaths and serious adverse events reported for Serevent could neither be attributed to use of the product, nor could Serevent be excluded as a cause. The drug's manufacturer, GlaxoSmithKline of Research Triangle Park, N.C., stopped the study, mostly due to difficulties in enrollment and the likelihood the study would not give a clear result.
The FDA is considering what steps are warranted to address this important new risk information. The FDA has emphasized that, based on available data, the benefits of Serevent for people with asthma continue to outweigh the risks and that serious problems reported in the trial were rare. The FDA has strongly advised that people who take Serevent should not stop taking it, or any other asthma drug, without first talking with their physicians.
National Asthma Education and
National Heart, Lung, and Blood Institute
Allergy and Asthma Network Mothers of Asthmatics
American Academy of Allergy, Asthma, and Immunology
American Lung Association
(800) LUNG-USA (586-4872)
Publication No. (FDA) 04-1302