Category: Featured Stories and Interviews

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Why Does Flu Trigger Asthma?

Why Does Flu Trigger Asthma? Study suggests new therapeutic targets for virally-induced asthma attacks

When children with asthma get the flu, they often land in the hospital gasping for air. Researchers at Children’s Hospital Boston have found a previously unknown biological pathway explaining why influenza induces asthma attacks. Studies in a mouse model, published online May 29 by the journal Nature Immunology, reveal that influenza activates a newly recognized group of immune cells called natural helper cells – presenting a completely new set of drug targets for asthma.

If activation of these cells, or their asthma-inducing secretions, could be blocked, asthmatic children could be more effectively protected when they get the flu and possibly other viral infections, says senior investigator Dale Umetsu, M.D., Ph.D., of Children’s Division of Immunology.

Although most asthma is allergic in nature, attacks triggered by viral infection tend to be what put children in the hospital, reflecting the fact that this type of asthma isn’t well controlled by existing drugs.

“Virtually 100 percent of asthmatics get worse with a viral infection,” says Umetsu. “We really didn’t know how that happened, but now we have an explanation, at least for influenza.”

Natural helper cells were first, very recently, discovered in the intestines and are recognized to play a role in fighting parasitic worm infections as part of the innate immune system (our first line of immune defense).

“Since the lung is related to the gut – both are exposed to the environment – we asked if natural helper cells might also be in the lung and be important in asthma,” Umetsu says.

Subsequent experiments, led by first authors Ya-Jen Chang, Ph.D., and Hye Young Kim, Ph.D., in Umetsu’s lab, showed that the cells are indeed in the lung in a mouse model of influenza-induced asthma, but not in allergic asthma. The model showed that influenza A infection stimulates production of a compound called IL-33 that activates natural helper cells, which then secrete asthma-inducing compounds.

“Without these cells being activated, infection did not cause airway hyperreactivity, the cardinal feature of asthma,” Umetsu says. “Now we can start to think of this pathway as a target – IL-33, the natural helper cell itself or the factors it produces.”

Personalized medicine in asthma?

The study adds to a growing understanding of asthma as a collection of different processes, all causing airways to become twitchy and constricted. “In mouse models we’re finding very distinct pathways,” Umetsu says.

Most asthma-control drugs, such as inhaled corticosteroids, act on the best-known pathway, which involves immune cells known as TH2 cells, and which is important in allergic asthma. However, Umetsu’s team showed in 2006 that a second group of cells, known as natural killer T-cells (NKT cells), are also important in asthma, and demonstrated their presence in the lungs of asthma patients. NKT cells, they showed, can function independently of TH2 cells, for example, when asthma is induced with ozone, a major component of air pollution. Compounds targeting NKT cells are now in preclinical development.

The recognition now of a third pathway for asthma, involving natural helper cells, may reflect the diversity of triggers for asthma seen in patients.

“Clinically, we knew there were different asthma triggers, but we thought there was only one pathway for asthma,” Umetsu says, adding that all of the identified pathways can coexist in one person. “We need to understand the specific asthma pathways present in each individual with asthma and when they are triggered, so we can give the right treatment at the right time.”

The study was funded by the National Institutes of Health.

Children’s Hospital Boston is home to the world’s largest research enterprise based at a pediatric medical center, where its discoveries have benefited both children and adults since 1869. More than 1,100 scientists, including nine members of the National Academy of Sciences, 12 members of the Institute of Medicine and 13 members of the Howard Hughes Medical Institute comprise Children’s research community. Founded as a 20-bed hospital for children, Children’s Hospital Boston today is a 395 bed comprehensive center for pediatric and adolescent health care grounded in the values of excellence in patient care and sensitivity to the complex needs and diversity of children and families. Children’s also is the primary pediatric teaching affiliate of Harvard Medical School. For more information about research and clinical innovation at Children’s, visit: http://vectorblog.org.

CONTACT:
Erin McColgan
Children’s Hospital Boston
617-919-3110
erin.mccolgan@childrens.harvard.edu

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Researchers Move Closer to Identifying New Class of Asthma, COPD Drugs

Researchers Move Closer to Identifying New Class of Asthma, COPD Drugs Says New Study

Researchers in Baltimore have identified new compounds whichrelax airway muscles and may provide relief from shortness of breath for patients with COPD and asthma. The bitter-tasting compounds are at least as, if not more, effective than currently available agents used to manage these diseases, and may present new options for treatment.

The study was presented at the ATS 2011 International Conference in Denver.

“We have identified compounds that are more potent than our previously identified set of compounds, paving the way for development of bronchodilators for treating asthma and COPD,”
said study author Kathryn Robinett, MD, pulmonary and critical care fellow at the University of Maryland School of Medicine. “These compounds represent a new class of bronchodilator that
work through an entirely different mechanism than beta-agonists like albuterol, salmeterol and formoterol.” Bitter taste receptors on taste buds of the tongue are thought to have evolved to warn people that they may be ingesting a toxic substance, Dr. Robinett explained. Previous studies revealed these receptors are also present on the smooth muscle surrounding the airways, which constricts in patients with asthma and COPD, reducing the size of the airway and making breathing difficult.

“We had been looking for airway smooth muscle receptors that, when activated, can relax this muscle for the past five years, and we were excited to find compounds that caused profound relaxation, in both mouse and human airways,” she said.

For their study, the researchers examined compounds known to be bitter suggesting they may be effective in relaxing these airway muscles. Once potential compounds were identified, the
researchers administered these compounds to mouse airways to examine their effects. They found that bitter compounds were at least as effective as beta-agonists in relaxing smooth airway muscle. Relaxation of active tension in these muscles in mice approached 100 percent for most compounds, compared to 30 percent for the beta-agonist isoproterenol. In a more limited number of studies in human airways, they continue to find bitter compounds to be somewhat more effective than beta-agonists. More importantly, they appear to work in different ways
inside the cell, so the two classes of drugs can work together to treat moderate to severe obstructive lung disease.

“These findings continue to support data that bitter taste receptor agonists could be the next major class of therapeutics in treating asthma and chronic obstructive pulmonary disease,” Dr.
Robinett said.

Obstructive lung disease, including asthma and COPD, continues to be a significant source of morbidity and mortality affecting 300 million people worldwide. “Unfortunately, despite widespread use of inhaled corticosteroids and long acting beta-agonists, and environmental controls, as many as one-half of people in the U.S. alone have inadequate control of asthma,” Dr. Robinett said. “Bitter taste receptor agonists may add to our armamentarium of treatment options.” Despite their impressive efficacy, the researchers found many of the compounds activate only one or two of the six main bitter taste receptors on airway smooth muscle, meaning that they may not taste very bitter on the tongue, which has 25 bitter receptors. “We continue to be amazed at the breadth of substances that activate these receptors,” Dr. Robinett said. “The plant world is packed with agents that can be effective therapeutics at these targets, or can provide us with the ‘molecular backbone’ to synthesize compounds that would be
better drugs.”
Dr. Robinett said this study is just the first step in a much larger task: identifying the compounds
which offer optimal results for COPD and asthmatic patients.
“There are over 10,000 compounds that are known to be bitter taste receptor agonists,” she said.
“These come from plants, including medicinal herbs and food additives, or are synthetic agents
that are used for entirely different medical reasons (such as chloroquine for treating malaria). So,
we have not only uncovered a previously unrecognized way to open the airways in asthma and
COPD, but we have many compounds to consider either ‘as they are,’ or as backbones for
synthesizing a new agent.
“Our challenge, then,” Dr. Robinett continued, “is to find safe agents that are not so bitter-tasting
as to make them unpalatable, and yet are able to affect the degree of relaxation of airway
smooth-muscle that we have found in experimental models.
“Our immediate focus is to gain a better understanding of second messenger pathways and
desensitization of bitter taste receptors, to continue to search for more agonists, and to carry out
toxicology studies on selected compounds,” Dr. Robinett said. “Then, with a set of our ‘best
compounds’ we will begin the process for Phase 1 clinical trials.”
###
“Bitter Taste Receptor Signaling On Airway Smooth Muscle: A Highly Efficacious Pathway For
Treating Obstructive Airway Disease” (Session A30, Sunday, May 15, 8:15-10:45 a.m., Room
501-502 (Street Level), Colorado Convention Center; Abstract 16969)
* Please note that numbers in this release may differ slightly from those in the abstract. Many of
these investigations are ongoing; the release represents the most up-to-date data available at
press time.
Abstract 16969
Bitter Taste Receptor Signaling On Airway Smooth Muscle: A Highly Efficacious Pathway For Treating
Obstructive Airway Disease
Type: Scientific Abstract
Category: 08.07 – LAM: Fundamental Mechanisms (RSF)
Authors: K.S. Robinett, D.A. Deshpande, S.B. Liggett; University of Maryland School of Medicine – Baltimore,
MD/US
Abstract Body
Rationale: We have recently shown expression of bitter taste receptors (TAS2R) on human airway smooth
muscle (HASM), that when activated by bitter agonists such as quinine and saccharin, evoke profound airway
relaxation. The relaxation is due to an increase in intracellular calcium ([Ca2+]i) that is temporally and spatially
restricted in HASM to a pool that activates the large conductance calcium-dependent potassium channel
(BKCa). However, the apparent affinity (potency) for these classic bitter tastants for HASM TAS2Rs is low, which
may limit therapeutic utility. Here we carried out biochemical and physiological studies to identify high-affinity
agonists acting at HASM TAS2Rs.
Methods: We utilized high throughput fluorescence-based screening (HTFS) of Fluo-4 AM loaded HASM cells
using libraries of compounds with structures suggesting that they may be agonists at one or more of the
TAS2Rs expressed on HASM (TAS2R10, 14, 31, 5, 4 and 19). Dose-response studies were used to determine
potency and efficacy. In confirmatory studies of the more potent compounds, HASM inositol phosphate (IP)
accumulation (an upstream event of [Ca2+]i) and intact airway relaxation studies (the final physiological
response) in isolated mouse tracheas, were also carried out.
Results: At high concentrations (1 mM) multiple previously unknown bitter-like compounds stimulated HASM
[Ca2+]i 1.5- to 3-fold over baseline, indicating activity at one or more of the six TAS2R subtypes. Similarly, up to
3-fold increase in agonist-promoted IP accumulation was found, consistent with the proposed TAS2Rgustducin-
ß?-PLCß-IP3 pathway in HASM. Dose-response studies with the HTFS-positive hits revealed
EC50values for some compounds in the nanomolar to low micromolar concentrations for the [Ca2+]i response. In
isolated airways of mice, the most potent of these were studied to ascertain potency and efficacy values for
relaxing acetylcholine constricted airways. There was a high correlation between these values for assessing
TAS2Rs in the cell-based [Ca2+]i assays vs. the relevant physiologic response. Relaxation of active tension
approached 100% for most compounds (as compared to 30% for the ß-agonist isoproterenol). This degree of
efficacy was found regardless of the TAS2R agonist being a “high”- or “low” affinity compound.
Conclusions: HTFS and IP accumulation studies in HASM, and, physiological studies in intact airways, have
revealed clinically favorable potency and efficacy profiles of novel TAS2R agonists. These compounds may be
useful therapeutics in aerosolized form in the treatment of asthma and COPD. Structural modification of these
compounds may further enhance their affinity for TAS2Rs.

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Study Evaluates Parents’ Reluctance to Vaccinate Asthmatic Kids

Study Evaluates Parents’ Reluctance to Vaccinate Asthmatic Kids Says Study

Concern over vaccine safety is one of the primary factors preventing parents from having their asthmatic children vaccinated for influenza, or flu, according to Michigan researchers. Parents who do not vaccinate their children are also less likely to view flu as a“trigger” for their child’s asthma, the researchers noted.

The study was presented at the ATS 2011 International Conference in Denver.

“When school starts in the fall, and during the winter season, many parents start dreading the cold and flu season,” said lead author Toby Lewis, MD, MPH, assistant professor of pediatric
pulmonology at C.S. Mott Children’s Hospital in Ann Arbor, Mich. “This is particularly true for parents of children with asthma, who recognize that ‘a little cold’ can quickly trigger an asthma
attack. Fortunately, there is something that can be done to reduce the chances of getting sick from influenza, one of the common winter viruses, and that is getting a vaccination to help
prevent this infection. “

Influenza vaccination is recommended for all children, but especially for children with asthma to
help prevent asthma exacerbations or ‘flares,’” Dr. Lewis added.“Despite this recommendation,
vaccination rates remain low. The reasons for under-immunization are poorly understood.”
To determine parental attitudes toward the flu vaccine, and learn the reasons why some parents
do not have their asthmatic children vaccinated, the researchers conducted a national survey from
August 13 – Sept 7, 2010 of 1,621 parents; 237 parents indicated at least one child had asthma
and were included in the final compilation of data.

“The parents included in the study were ethnically diverse and were from a broad spectrum of
economic backgrounds,” Dr. Lewis noted.

Of those surveyed, 70 percent reported that they vaccinated their child against seasonal or H1N1
influenza during the prior winter season (2009-2010), and 65 percentstated that they planned to
have their child vaccinated against influenza in the upcoming season (2010-2011), indicating
consistency in vaccination behavior. The study also found that parents who did not vaccinate
their asthmatic children against influenza were less likely than those that did vaccinate indicate
that getting a viral infection was a “very important” trigger of their child’s asthma (53 percent vs.
72 percent), and were more likely to be concerned about vaccine side effects (60 percent vs. 26
percent) and getting sick from the vaccine itself (41 percent vs. 13 percent).

“Not surprisingly, parents who felt that their children were likely to experience an asthma attack
when they got a respiratory infection were more likely to get their child vaccinated,” Dr. Lewis
said. “Worries about potential side effects of the vaccine emerged as an important factor for
families who did not have their child vaccinated. The group as a whole indicated that their
physician was an important source of health information for their family – suggesting that
physicians may have an opportunity to advise families about this important preventative
measure.”

The survey also identified exposures in addition to colds and flu that parents believe are most
likely to trigger asthma attacks, including:

• exposure to smokers (73 percent);
• exposure to outdoor allergens such as pollen and weeds (81 percent);
• outdoor air quality/pollution levels (77 percent);
• exposure to indoor allergens such as dust mites and cockroaches (71 percent)
• contact with furry or hairy animals (48 percent); and,
• food(30 percent).

Dr. Lewis noted that the study provides helpful insight into the way families of children with
asthma view influenza infection and the influenza vaccine.

“The results will help physicians, public health professionals and health educators tailor
messages most effectively to this group of families,” she said.“We will continue to analyze our
current survey results to better understand parent attitudes, and hope to work with colleagues to
develop educational messages specifically designed for parents who have previously opted out of
vaccinating their children against influenza – for instance, highlighting stories from parents of
children with asthma who did get their child vaccinated to help show a positive experience with
influenza vaccination.”

This study was funded by the C.S. Mott Children’s Hospital National Poll on Children’s Health
Pediatric Faculty Participation Program, through the generosity of the University of Michigan
Department of Pediatrics and Communicable Diseases.

“Parental Attitudes Associated With Vaccinating Asthmatic Children Against Influenza In A
National Poll On Children’s Health” (Session B101, Monday, May 16, 2:00 p.m.-4:30 p.m.,
Room 503-504 (Street Level), Colorado Convention Center; Abstract 17569)
* Please note that numbers in this release may differ slightly from those in the abstract. Many of
these investigations are ongoing; the release represents the most up-to-date data available at
press time.

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Visits to Asthma Specialists Delayed for African-American Children

Visits to Asthma Specialists Delayed for African-American Children Says New Study

African-American children are more likely to report previous emergency room visits, hospitalizations and need for intensive care unit (ICU) management for asthma than Caucasian children on their first visit to an asthma specialist, according to a study conducted by researchers at Johns Hopkins University. The study also indicated that African-American children have poorer lung function at their initial visit to an asthma specialist than their Caucasian counterparts.

The study will be presented at the ATS 2011 International Conference in Denver. “Our study shows significant differences in levels of pre-existing illness exist between white and black children at the time of initial visit to an asthma specialist, suggesting a delay in receipt of specialist care,” said study author Sande Okelo, MD, assistant professor of pulmonary medicine
at Johns Hopkins University. “When children with asthma are doing poorly despite the best efforts of their primary care provider, national asthma guidelines recommend that these patients be referred to an asthma specialist,” added Dr. Okelo, who is also a pediatric pulmonary specialist at Johns Hopkins Children’s Center. “This disparity highlights the need to better identify and address the reasons
for delayed presentation of African-American patients who would benefit from specialist care.” To conduct their study, researchers enrolled parents of 224 children, including 124 Caucasian children and 80

African-American children, presenting to Johns Hopkins Children’s Center for initial consultation for asthma and asked them to provide information on their child’s current level of asthma control, as well as emergency department visits, hospitalizations and oral steroid use from the previous two-month period. Parents were also asked to provide medical history data, including lifetime total number of prior hospitalizations and intensive care unit stays. Children’s lung function also was assessed. Both groups had similar levels of recent and average total lifetime steroid use. Significant
differences were observed for recent evidence of acute health care use, total number of
hospitalizations and total number of ICU stays. “At the first visit with the asthma specialist, African-American parents provided reports of their
child’s past asthma history that indicated they had experienced a greater burden from asthma
than their Caucasian counterparts,” said Dr. Okelo. “More specifically, African-American
patients were more likely to have emergency department visits and hospitalizations, were more
likely to require care in an intensive care unit, to have poorer lung function and to have less wellcontrolled
asthma at the time of the first asthma specialist visit.”
Despite some well-described racial disparities in other facets of asthma care, Dr. Okelo said
these findings were still a bit unexpected.
“It was not anticipated that there might be delays in asthma specialist care for the sickest of
children with asthma,” he said. “In fact, it is assumed that the sickest of children are
appropriately referred in a timely fashion to asthma specialists, regardless of race. These findings
suggest that African-American patients are suffering longer from poorly controlled asthma than
their Caucasian counterparts before being seen by an asthma specialist.”
Dr. Okelo said the current study was part of a larger effort to establish a registry within the
division of pediatric pulmonary medicine at Johns Hopkins to systematically collect relevant
clinical information during routine patient visits using standardized patient surveys. Future
studies may help researchers learn if care by an asthma specialist removes some or all of the
disparities between African-American and Caucasian asthmatic children, and help them develop
strategies to overcome the barriers that interfere with the referral process.
“We would like to confirm these findings in a larger patient population,” Dr. Okelo said. “This
study and future studies also may help to further clarify and standardize the criteria which should
be used to determine which children should be referred to asthma specialists, and when those
referrals need to occur.”
###
“Do Asthma Morbidity Disparities Exist Between Black And White Children Referred To
Asthma Specialist Care?” (Session B101, Monday, May 16, 2:00-4:30 p.m., Room 503-504
(Street Level), Colorado Convention Center; Abstract 19727)
* Please note that numbers in this release may differ slightly from those in the abstract. Many of
these investigations are ongoing; the release represents the most up-to-date data available at
press time.

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Long-Term Study Demonstrates Safety and Efficacy of SYMBICORT

Long-Term Study Demonstrates Safety and Efficacy of SYMBICORT® in African American Patients with Asthma

AstraZeneca (NYSE:AZN) today announced results from a long-term study comparing SYMBICORT® (budesonide/ formoterol fumarate dihydrate) Inhalation Aerosol 160/4.5 mcg with budesonide pressurized metered-dose inhaler (pMDI) 160 mcg in self-reported African American patients with moderate to severe persistent asthma. The data demonstrated that SYMBICORT treatment resulted in significant improvement in lung function compared to treatment with budesonide alone, and safety results indicated that patients in the SYMBICORT group had fewer exacerbations over the randomized study period compared to patients treated with budesonide.1-2 The incidence of adverse events (AEs) was similar between the two groups.2 The results were presented in a poster at the 2011 American Thoracic Society (ATS) International Conference in Denver.

“Data from this year-long study of SYMBICORT supports our understanding of the product’s efficacy and safety in African American patients.”

SYMBICORT is a combination asthma medication that contains both an inhaled corticosteroid (ICS) (budesonide) and a long-acting beta-agonist (LABA) (formoterol). It is indicated for the treatment of asthma in patients 12 years of age and older not adequately controlled on a long-term asthma control medication, such as an ICS, or whose disease severity clearly warrants initiation of treatment with both an ICS and LABA.3

“African American patients are disproportionately affected by asthma – asthma prevalence is higher for African Americans than for Caucasians,” said Dr. Ubaldo Martin, Director of Clinical Research at AstraZeneca. “Data from this year-long study of SYMBICORT supports our understanding of the product’s efficacy and safety in African American patients.”

There have been few prior studies evaluating combination asthma treatment in specific ethnic populations at higher risk for asthma prevalence. Results from this 52-week study are consistent with safety and efficacy data from the TITAN study, a 12-week study of SYMBICORT in African American patients, and with previous SYMBICORT studies conducted among predominantly Caucasian patients.4-6

About the Study

The 52-week, randomized, double-blind Phase III study included 742 self-reported African American patients 12 years of age and older with moderate to severe persistent asthma. After two weeks of receiving two inhalations, twice daily of budesonide 160 mcg, patients were randomized to receive two inhalations, twice daily of SYMBICORT 160/4.5 mcg or two inhalations, twice daily of budesonide 160 mcg.2

Results from the study showed:

Fewer patients receiving SYMBICORT (7.7%) compared to budesonide (14.0%) had ?1 asthma exacerbation (oral/systemic corticosteroid use, an asthma-related hospitalization, or emergency room/urgent care visit) (P=.006) 2
The time to first asthma exacerbation was longer in patients treated with SYMBICORT compared to budesonide (P=.018) 2
Similar percentages of patients had ?1 AE, the most common AEs were headache, nasopharyngitis, sinusitis and viral upper respiratory tract infection2
Treatment with SYMBICORT resulted in significantly greater improvements in predose forced expiratory volume in one second (FEV1), predose forced vital capacity (FVC), and morning peak expiratory flow (AM PEF) compared to budesonide1
Improvements in predose FEV1 were observed after two weeks of randomized treatment with SYMBICORT, without diminution of effect relative to budesonide during the treatment period1

No new safety concerns were identified with SYMBICORT during the course of the study. The most common adverse events for patients receiving SYMBICORT or budesonide were headache, nasopharyngitis, sinusitis and viral upper respiratory tract infection.2

About Asthma in African Americans

African Americans are more likely to be diagnosed with asthma in their lifetime, and asthma prevalence is higher in African American patients compared to Caucasians.7

Important Safety Information, including boxed WARNING3

WARNING: ASTHMA RELATED DEATH

Important Safety Information, including boxed WARNING

WARNING: Long-acting beta2-adrenergic agonists (LABA), such as formoterol, one of the active ingredients in SYMBICORT, increase the risk of asthma-related death. A placebo-controlled study with another LABA (salmeterol) showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including formoterol. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients
When treating patients with asthma, prescribe SYMBICORT only for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (eg, discontinue SYMBICORT) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use SYMBICORT for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids

SYMBICORT is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms

It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may occur, particularly at higher doses. Particular care is needed for patients who are transferred from systemically active corticosteroids to inhaled corticosteroids. Deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids.

Patients who are receiving SYMBICORT should not use additional formoterol or other LABA for any reason.

Due to possible immunosuppression, potential worsening of infections could occur; a more serious course of chickenpox or measles can occur in susceptible patients.

Excessive beta-adrenergic stimulation has been associated with central nervous system and cardiovascular effects. SYMBICORT, like all products containing sympathomimetic amines, should be used with caution in patients with convulsive disorders, thyrotoxicosis, and cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Beta-adrenergic agonist medications may produce hypokalemia and hyperglycemia in some patients.

As with other inhaled medications, paradoxical bronchospasm may occur with SYMBICORT. Use with caution in patients with diabetes mellitus.

Long-term use of orally inhaled corticosteroids, such as budesonide, a component of SYMBICORT, may result in a reduction in growth velocity and/or a loss of bone mineral density.

Glaucoma, increased intraocular pressure, and cataracts have been reported following the inhaled administration of corticosteroids, including budesonide, a component of SYMBICORT.

In rare cases, patients on inhaled corticosteroids may present with systemic eosinophilic conditions.

SYMBICORT should be administered with caution to patients being treated with MAO inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents. Caution should also be exercised in patients on long-term ketoconazole and other known potent CYP3A4 inhibitors.

The most common adverse reactions ?3% reported in clinical trials included nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis.

Indications

SYMBICORT is indicated for the treatment of asthma in patients 12 years and older (also see boxed WARNING).

SYMBICORT is NOT indicated for the relief of acute bronchospasm and should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma.

Please see full Prescribing Information, including boxed WARNING, and visit www.MySYMBICORT.com

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

For more information about AstraZeneca in the US or our AZ&Me™ Prescription Savings programs, please visit: www.astrazeneca-us.com or call 1-800-AZandMe (292-6363).

References:
1. Brown, R.W. Differential Long-term Pulmonary Function Outcomes of Budesonide/Formoterol Pressurized Metered-Dose Inhaler pMDI and Budesonide pMDI in African-American Patients with Asthma. [poster]. American Thoracic Society, May 13-18, 2011, Denver, CO. Abstract #17354.
2. Brown, R.W. Long-term Safety of Budesonide/Formoterol Pressurized Metered-Dose Inhaler Budesonide pMDI in African-American Patients with Asthma: Asthma Exacerbation Adverse Events. American Thoracic Society, May 13-18, 2011, Denver, CO. Abstract #17354.
3. Symbicort Prescribing Information. AstraZeneca.
4. Spector, S., Martin, U., Uryniak, T., O’Brien, C. Effect of Budesonide/Formoterol Pressurized Metered-Dose Inhaler Versus Budesonide Dry Powder Inhaler on Pulmonary Function in Black Adolescents and Adults with Moderate to Severe Persistent Asthma [oral presentation]. American College of Chest Physicians Annual Meeting, October 30-November 4, 2010. Vancouver, BC, Canada.
5. Spector, S., Martin, U., Uryniak, T., O’Brien, C. Safety and Tolerability of Budesonide/Formoterol (BUD/FM) Pressurized Metered-Dose Inhaler (pMDI) in Black Adolescents and Adults with Moderate to Severe Persistent Asthma. [oral presentation]. American College of Chest Physicians Annual Meeting, October 30-November 4, 2010. Vancouver, BC, Canada.
6. Noonan, Michael. Efficacy and Safety of Budesonide and Formoterol in One Pressurised Metered-Dose Inhaler in Adults and Adolescents with Moderate to Severe Asthma.
7. American Lung Association. Epidemiology & Statistics Unit, Research and Program Services. Trends in Asthma Morbidity and Mortality, February 2010. Accessed April 27, 2011: http://www.lungusa.org/finding-cures/our-research/trend-reports/asthma-trend-report.pdf

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May is Asthma Awareness Month

May is Asthma Awareness Month and U.S. EPA Administrator visits Children’s Mercy in KC to Celebrate

Missourinet reports that EPA Administrator Lisa Jackson toured Children’s Mercy Hospital in Kansas City, MO today, highlighting Asthma Awareness Month.

Jackson says the Environmental Protection Agency has a role to play in the battle against asthma.

“It’s EPA’s job to enforce our country’s landmark Clean Air Act,” Jackson says in an interview with the Missourinet. “And that act has saved millions of lives over the 40 years it’s been in place. We still have work to do. We have to reduce levels of smog and fine particles and soot in our air which trigger asthma, bronchitis, lung disease, heart disease and premature death.”

Jackson says that for the Midwest, air pollution primarily comes from vehicle emissions and the emissions from coal-fired power plants. Jackson says the cause behind Asthma Awareness Month is personal for her, because her youngest son suffers from asthma and she understands the struggle both the child and the parents have in dealing with the ailment.

AUDIO: Brent Martin interviews EPA Administrator Lisa Jackson [4:30 MP3]

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Asthma and Vietnam

4,000 Vietnamese Asthma Sufferers Die Yearly

According to Saigon GP Daily, Around 4,000 Vietnamese people die for asthma attacks annually.
Some causes of the disease

The figures were released at a meeting and scientific seminar on asthma, held in Hanoi on May 10 by Hanoi-based Bach Mai Hospital and the Vietnam Association of Asthma, Allergies and Clinical Immunology, in response to World Asthma Day, which is usually held in the first week of May.

In addition, approximately four million asthma sufferers in the country, accounting for five percent of the country’s population, of whom, 8-12 percent are children, according to Health Deputy Minister Nguyen Thi Xuyen at the meeting.

Moreover, 62 percent asthma sufferers across the country have not received long-term preventative treatment meanwhile 65 percent people can not control their asthma attacks.

The theme of the meeting was “Is your asthma under your control” because asthma control plays key role in the anti-asthma treatment program yet the rate of asthma control in the globe is still very low, at 5 percent.

Environmental pollution, rampant use of medicine and chemicals in treatment and life, pressure living speed, bad weather, and lack of knowledge of asthma disease are causes of the disease.

According to the Director of the Vietnam Association of Asthma, Allergies and Clinical Immunology, Nguyen Nang An, said that research conducted by the Asia-Pacific Association has show that Vietnam ranks 7th out of 12 surveyed countries in the region in terms of asthma control.

Among dignitaries guests at the meeting were Hen, Bach Mai Hospital’s director Nguyen Quoc Anh, former director of the hospital Tran Thuy Hanh, representatives from relevant agencies and hospitals.

Posted on

Food Allergy Challenges

Food Allergy Challenges, Asthma and U.S. National Guidelines

In this PBS audio podcast on Food Allergy, the invited experts discuss Food Allergy Challenges and new national U.S. Guidelines for physicians and patients.

Topics covered:

* Food Allergies and New U.S. National Guidelines
* Food Intolerance vs. Food Allergy
* Benefits, Pitfalls and Challenges of Comprehensive Food Panel and Test
* Benefits and challenges of logging your diet
* Benefits of advocating for yourself
* Improvements in research and diagnostic testing

Ten to 12 million people in the U.S. suffer from a food allergy, according to the National Institute of Allergy and Infectious Diseases — and the number is growing. Diagnosis and treatment can be difficult. The NIAID hopes the new guidelines will help physicians identify and manage food allergies.

NEAL CONAN, host:

This is TALK OF THE NATION. Im Neal Conan in Washington.

Food allergies are all too common. As many as 12 million Americans may have one or more, and they can be dangerous, sometimes even fatal. But it can be hard to figure out who’s allergic and who isn’t, and the severity of reactions can vary greatly. A whiff of peanuts can make one person break out in hives or send another into anaphylactic shock.

Many restaurants and schools don’t label meals that contain the foods that can trigger an allergic reaction or at least not correctly sometimes, and the number of cases appears to be on the rise.

The National Institute of Allergy and Infectious Diseases released new guidelines in December to help health care professionals who treat patients with food allergies. If that’s you or your child, how did you and your doctor figure it out? Tell us your story. 800-989-8255. Email us, talk@npr.org. You can join the conversation on our website. That’s at npr.org. Click on TALK OF THE NATION.

Later in the program, crowd disasters. What really triggers a dangerous crush? And new ideas on prevention. But first, food allergies, and we begin with Matthew Fenton, chief of the Asthma, Allergy and Inflammation Branch at the Division of Allergy, Immunology and Transplantation -almost made it through – at the National Institute of Allergy and Infectious Diseases. That’s not quite a mouthful. He joins us here in Studio 3A. Thanks very much for being with us.

Dr. MATTHEW FENTON (Chief, Asthma, Allergy and Inflammation Branch, Division of Allergy, Immunology and Transplantation, National Institute of Allergy and Infectious Diseases): Thank you. It’s a pleasure to be here.

CONAN: And why the necessity for new guidelines?

Dr. FENTON: Well, we were actually approached by a patient advocacy group and a professional medical society back in 2007 with the idea that there needed to be updated food allergy clinical guidelines that would speak to the entire clinical community and not simply be guidelines written by allergists for allergists, which has been the case sometimes in the past.

And so we took on the challenge of creating guidelines that could be broadly useful across the clinical spectrum, ranging from the specialist to the general family practice doctor.

CONAN: Does that suggest that, at least in the past, treatment have been very different?

Dr. FENTON: Well, diagnosis and management of food allergy has been very different. One of the startling facts is that there is not even a common definition for food allergy that is used by physicians in different types of practice.

One of the things we did when we started the project of creating guidelines was to look at the definitions that were out there, and they vary quite a bit. So we had our work cut out for us.

CONAN: In fact, it’s sometimes hard to distinguish, and certainly from a layman’s point of view, between an allergy and an intolerance.

Dr. FENTON: Absolutely. The symptoms can be very similar, and it’s certainly quite plausible that a diagnosis of food allergy can be made, only to later find out it’s a food intolerance.

And interestingly, for patients who self-report that they have an allergy to their doctor, 50 to 90 percent of the time, they’re actually incorrect, and they have a food intolerance.

CONAN: And what’s the difference in terms of treatment?

Dr. FENTON: Well, there – for food allergies, which are a disease that’s based on a defect in the immune response to food, there is no treatment. We can only advise patients and their families to manage the diet and be very careful to avoid consumption of the food or to manage symptoms, if they’re mild, with antihistamines, or in the case of severe reactions, you may have to use epinephrine.

In the case of food intolerance, you certainly want to avoid the food, as well, but in cases such as lactose intolerance, you know exactly what you need to avoid in milk products, but also there are pills available to provide the missing lactase enzyme, and you can actually then go on to consume milk products.

CONAN: And allergies can be, I think devilish is probably as good a word as any, figuring out what it is you’re allergic to.

Dr. FENTON: Well, that’s a very important point. And one of the things I want to stress at the beginning is that there’s a difference between allergic sensitization and allergic disease, that the immune system may recognize a number of different allergens, but you may only have clinical disease arising from one of those allergens.

CONAN: So give me a for instance there.

Dr. FENTON: Well, for instance, let’s take food allergies, since it’s the topic of the day. You may have an immune response against a number of different foods. A child may be allergic to milk and egg and peanut. But which one is actually causing the symptoms? And finding out which is the culprit is a large part of the challenge the physician faces. But only the one that you have clinical symptoms from is the one you have to avoid in your diet.

CONAN: Dr. Fenton, stay with us. We’re going to turn to somebody who has to deal with some of these problems in his practice. Dr. Hemant Sharma is director of the Food Allergy Program at Children’s National Medical Center here in Washington, D.C., also with us here in Studio 3A. And you deal with these kinds of questions all the time.

Dr. HEMANT SHARMA (Director, Food Allergy Program, Children’s National Medical Center): Absolutely. I was just dealing with them this morning, in fact, with several of our patients that came to see us.

And, you know, the concerns that families have when they come to see us as a specialist is, number one, making the diagnosis. Oftentimes, they come to us after having had various tests done and without much clarity as to whether their child really has a food allergy, and if they do, which foods are they really allergic to.

CONAN: And we’re talking children here, but are most allergies diagnosed in children?

Dr. SHARMA: Well, of the about 12 million people in the U.S. who have a food allergy, three million of them are estimated to be children. So there are a number of adults who have food allergy, some of whom had food allergy as kids and never outgrew them. And some adults develop food allergies later in life.

CONAN: So is that a separate category?

Dr. SHARMA: Not necessarily. They all work through the same mechanisms, and, you know, going back to what Dr. Fenton said, food allergies, by definition, involve the immune system.

And so most of the time, when it comes to a food allergy, that will happen early in childhood. However, for example with fish and shellfish, that allergy can develop anytime, later in adulthood.

CONAN: And is the testing still, well, we’ll give you a little of this and see what happens?

Dr. SHARMA: Not exactly, and I think that’s one of the strengths of the food allergy guidelines that we’re discussing is that they’re giving us a framework for the interpretation of these tests.

There are a number of tests that allergist, immunologists can do when a child or an adult comes to them with food allergy concerns. A skin test can be done. A blood test can be done. And sometimes those tests are not always accurate. There can be false positives, as we were discussing before.

So the job that we have in front of us is to take not only the test results but more importantly the history of what happened, the history of when your child or when you ate this food, what symptoms occurred, how soon did they occur. And we put all that together to help make a diagnosis.

CONAN: And especially in the case of children, of course, the parents are sometimes distraught because these reactions can sometimes be very scary.

Dr. SHARMA: Absolutely. I mean, food allergy for a parent is a very frightening thing to go through, particularly in young children. They have life-threatening reactions. These are not the kinds of allergy symptoms that we think of with hay fever, for example, a runny nose or itchy eyes. These symptoms can be a drop in blood pressure, a dangerous tightening or swelling involving the through. And they can be potentially fatal. And so for parents, this is a very, very scary prospect.

CONAN: As a practitioner, do you look at these new guidelines and say: Does this make sense to you? And does it clarify – did these definitions clarify procedures throughout the profession?

Dr. SHARMA: Absolutely. As an allergist-immunologist who treats people with food allergies, these guidelines have been incredibly helpful, number one in terms of getting us on the same page.

I think as Dr. Fenton was alluding to, there’s a wide variety of clinical practice when it comes to food allergy, and as practitioners, we all needed a set of common guidelines to help us to decide what we should do when a patient comes to us with a potential food allergy.

And then furthermore, for patients themselves, it gives us a set of guidelines to guide them in better understanding and managing their food allergies.

CONAN: Let’s get a caller in on the conversation, 800-989-8255. Email us, talk@npr.org. If you have a food allergy, or your child does, tell us how you and your doctor figured that out. Megan(ph) joins us on the line, calling from Mountain View in California.

MEGAN (Caller): Hi.

CONAN: Hi, Mega, you’re on the air. Go ahead, please.

MEGAN: So, I’ve been working actually from the opposite perspective of not necessarily thinking I have food allergies but having a lot of symptoms, and over the last year working with a naturopath until we ended up sending my blood in to get a comprehensive food panel. And they sent back a list of about 30 different foods, which I’m allergic to.

CONAN: And those include?

MEGAN: Oh my God, from lychee to soy to wheat to yeast to gluten. The list is really long. You probably don’t want me to read the whole one.

CONAN: And what does that leave you eating?

MEGAN: You know, it has left me learning to cook, because I can’t go to restaurants or even get the processed food or even the soups at Whole Foods because they’d have garlic in them. So I’ve been learning to cook and adapt recipes to leave out the ingredients. (Unintelligible) in the morning and soup at lunch.

CONAN: After getting this rather ferocious list, I wondered if you considered a second opinion.

MEGAN: So what I’m doing is, starting January 1st, for the past month, I cut out all of these 30, 40 different foods. And now each week, I’m going to introduce a new food and see what I’m actually reacting to. And if I don’t have a reaction, as I’m keeping a log, then I can put the food back in my diet.

CONAN: But have you considered going, trying another doctor and saying is this a reasonable approach?

MEGAN: I haven’t. I have three different friends who’ve done this, one who last year they, the medical doctors had diagnosed her with maybe having a brain tumor. And after she did the same medical test and cut these foods out, she – a lot of her symptoms went away.

CONAN: And she’s doing well?

MEGAN: She’s doing really well. So went from a possible brain tumor to really being about food allergies.

CONAN: Megan, thanks very much for the call. And good luck. And good luck with the cooking, as well.

I wonder, Dr. Sharma, is this a reasonable approach? I mean, that seems like an awfully strong reaction.

Dr. SHARMA: It’s – well, I guess I’ll resort back to the guidelines because that’s what we’re here focusing on today. The guidelines make it pretty clear that as practitioners, we really should avoid doing these indiscriminate panels of testing to a number of different foods. And the reason is that there can be false-positive results or what is other called sensitization.

Sensitization means that when they do the blood test to look for the IGE, the allergic antibody to the food, they find the IGE to the food, but it could be that that the IGE really is having no clinical consequence at all in terms of an allergy.

And so many of us are walking around with IGE antibody in our blood, to a number of different foods, but we’re not allergic to that food. And really, the only true diagnosis of a food allergy is what happens when you eat the food.

CONAN: So that approach, cut them all out and then introduce one at a time and see what happens?

Dr. SHARMA: It could be. I mean, the symptoms of a food allergy that involves IGE are very clear. If you have a food allergy involving IGE, it won’t be presenting vaguely, as this did.

CONAN: All right. Stay with us, if you would. We’re talking with Dr. Hemant Sharma and also with Dr. Matthew Fenton about food allergies and new guidelines on how they’re diagnosed and treated. If you or your child suffer from food allergies, how did you and your doctor figure that out? Tell us your story, 800-989-8255. Email talk@npr.org. Stay with us. I’m Neal Conan. It’s the TALK OF THE NATION from NPR News.

(Soundbite of music)

CONAN: This is TALK OF THE NATION, from NPR News. I’m Neal Conan.

We’re talking today about food allergies. About one in 20 children have them, one in 25 adults. Those numbers seem to be rising. As of this past December, those with food allergies have new guidelines for diagnosis and management.

If that includes you and your child, how did you and your doctor figure it out? Give us a call: 800-989-8255. Email us: talk@npr.org. You can also join the conversation at our website. That’s at npr.org. Click on TALK OF THE NATION.

Just before the break, we had a caller, Megan, who was describing a panel of tests that she had done, a blood screening. And Dr. Matthew Fenton, chief of the Asthma, Allergy and Inflammation Branch in the Division of Allergy, Immunology and Transplantation at the National Institute of Allergy and Infectious Diseases – I got through it that time – wanted to come back on that.

Dr. FENTON: I think the caller raised a very important issue that’s very commonly seen among people who have food allergy or suspect they have food allergy. But it’s important to put it into context.

Food allergy afflicts about five percent of Americans. But 50 percent of Americans actually have some detectable level of the allergic IGE antibody against a food. So, far more people have some state of allergic sensitization than actually have clinical disease.

So what these test panels show you, a blood test, a RAST test or a skin test, is – tells you about the foods you’re sensitized to. And the danger, especially in children with suspected food allergy, is to not restrict the diet to the point where your nutrition is harmed.

It’s important to identify the allergen that actually causes symptoms and then work from there. And to identify that allergen, we, in the guidelines, recommend something called the oral food challenge, to precisely identify the causative food.

CONAN: Here’s an email we have from Beth in Greenville, Wisconsin: I’m in my 40s, and something has always stymied me and others that I’ve spoken to about this topic. When I was a kid, I don’t remember anybody in my school class that had allergies to such things as peanut butter, peanuts.

What happened between now and then? Why are there now more kids that have a serious enough allergy to peanut products that they’re banned from sending peanut butter and jelly sandwiches in school lunches?

Dr. Fenton, would you address that?

Dr. FENTON: We think at this point that the increase in food allergy that’s been seen over the past few decades reflects a similar increase in allergic diseases across the board – so asthma, hay fever, for example. We’ve seem similar rises.

Now, why this is occurring is really still scientifically a mystery. There’s certainly factors in the environment, factors in our lifestyle, factors in our diet that are involved. And one hypothesis that’s been put forward to help explain this is something called the hygiene hypothesis, that says as our environments and lifestyles get cleaner, and we are less exposed to microbes, and we use higher – antibiotics at a higher frequency, that our immune systems, in a sense, are looking for something to do. They’re not able to do their normal job, which is to fight off pathogens in the environment, because we have such a clean environment.

Now, that’s a somewhat naive hypothesis, but there are some very strong points to that that are likely to underlie the connection between the cleaner environment, the trend in increased allergic diseases and our immune system looking for something to do.

CONAN: Let’s introduce another voice in the conversation: Julia Bradsher, chief executive officer of the Food Allergy Anaphylaxis Network, a group that supports awareness and research on this subject. She also joins us here in Studio 3A.

Nice to have you with us today.

Ms. JULIA BRADSHER (Chief Executive Officer, Food Allergy Anaphylaxis Network): Thank you.

CONAN: And yours was one of the groups that urged the conduct of this new guideline?

Ms. BRADSHER: Yes, FAAN, the Food Allergy Anaphylaxis Network, was very instrumental in pushing for these guidelines so that families with food allergies could be better supported.

CONAN: And if there’s one misconception that people have about allergies, what would it be?

Ms. BRADSHER: I guess one of the greatest misconceptions is something that Dr. Fenton mentioned earlier, which is that people think that a food allergy is, you know, basically a sneeze or, you know, a cough: You eat something, and you sneeze.

But it’s really a potentially life-threatening condition. And, you know, people are walking around, you know, being exposed on a daily basis to a potential allergen that, if they consume it, it could be fatal.

CONAN: And just given the numbers that we were talking about earlier, is that emailer right? I mean, you know, entirely possible that 40 years ago, when she was in school, this didn’t seem to be a problem, and now it is.

Ms. BRADSHER: I talk to people all the time about food allergies, and one of the things I hear frequently is: When my child started, there was one child, mine, in a classroom. And today – you know, that was in kindergarten. Today, my child’s in the fifth grade, and there’s 10 children. So we hear this anecdotally all the time.

CONAN: President Obama signed the Food Allergy and Anaphylaxis Management Act into law at the beginning of last month, after five years pending in Congress. What changes is that going to portend?

Ms. BRADSHER: Well, the wonderful thing about getting the FAAMA passed and getting it signed into law is that we now have guidelines for the country for schools to manage food allergies in the schools.

CONAN: And that means we’re not going to see peanut butter in the cafeteria?

Ms. BRADSHER: What it means is that schools now have – no matter if it’s a school in California or a school in Virginia, those schools have uniform guidelines that they can go to to learn how to manage the food allergies in schools.

CONAN: All right, let’s get another caller on the line. And this is Derrick(ph), Derrick with us from Louisville.

DERRICK (Caller): Yeah, it’s Louisville, actually, west of the Mississippi.

CONAN: Oh, the wrong Louisville. I apologize. Louisville in Colorado. Go ahead.

DERRICK: That’s okay. Yeah, my son has a Latex allergy, and we discovered it when he was a baby, about 18 months old, and when he was doing an eczema study for some topical medication and his arms swelled up like a balloon right in front of our eyes at the doctor’s office. And it turned out it was because of the Latex gloves the nurses were wearing when they were taking blood draws.

And – so because it was a part of a study, we had to find out what exactly it was. It turns out, it was the Latex. And because of that, that protein crosses over into foods like bananas and cantaloupe and honeydew and kiwi and a whole list. And things we know, like bananas, he can’t really even touch without having an allergic reaction. It’s not about eating it. It’s just about coming into contact with it.

CONAN: Mm-hmm. And how does that change his life?

DERRICK: Well, he’s got an EpiPen that he’s got to have with him everywhere, and…

CONAN: That’s in case he needs an injection to save his life.

DERRICK: Yeah, right, right. Balloons for parties in the classroom, you know, Latex balloons, especially if they have a little powder inside of it, if it pops, then it floats around in the air. Or, you know, the foods that are mixed in a fruit salad. Usually, he can’t even touch a fruit salad, even though there may be, say, a strawberry that he could eat, but the cross-contamination is there.

So it’s – he’s really had to educate and be an activist – or not an activist, but, you know, speak up for himself and say, you know, I can’t eat that. I can’t touch that. And this needs to not be in my classroom because I don’t want to use my EpiPen.

CONAN: Yeah. Dr. Sharma, is this all too common?

Dr. SHARMA: It is. And what you’re describing, Derrick, is you used the exact right term. It’s cross-reactivity. And so there are – our bodies, oftentimes, our immune system will see proteins that are similar structurally in the same way. So the Latex protein that your son is reacting to is similar to some of the proteins that are present in these other fruits, like banana, kiwi, avocado, mango.

And so even touching a food can, in some children, cause a reaction. The route of exposure that most commonly will cause a reaction is ingestion, actually eating the food, but reactions can also occur through contact and, in rare cases, even through inhalational exposure.

CONAN: And Julie Bradsher, I wanted to ask you: That part about becoming his own advocate, that’s what your organization talks a lot about, too.

Ms. BRADSHER: Yeah. We do – we spend a lot of time talking with families about how to advocate for themselves, whether it’s in the school, in a restaurant, on an airline. You know, we – that’s an important factor. And for kids in particular, they really have to learn how to speak up for themselves. And, you know, I’ve met many parents, many children where the kids are actually very resilient. They’re incredibly great advocates for themselves.

CONAN: Derrick, how old is your son now?

DERRICK: He’s going to be 14 in two weeks. But – so he’s grown up with this, and, you know, being an advocate for himself, he’s really done well.

CONAN: And is this something he’s likely to grow out of? Is that what you’re told?

DERRICK: No. We’re told it’s a lifetime thing that he needs to be, you know, always watchful of.

CONAN: Well, we wish you and him the best of luck. Thanks very much for the call.

DERRICK: Yeah.

CONAN: There’s an email from Amy in Cincinnati: On a recent mission trip with my church to a township in South Africa, we were doing a children’s program and provided a snack. The snack the locals provided was a raisin-peanut trail mix. We immediately voiced our concern for peanut allergies with the kids, and the moms laughed at us. They’d never heard of such a thing. Are allergies more common in certain countries? Why is there not a peanut allergy problem in South Africa?

Dr. Fenton, is that the peck-of-dirt syndrome that we were talking about before?

Dr. FENTON: Well, that may be part of it in certain areas. But this geographical restriction of food allergies is really a fascinating phenomena. And clearly, if you take Africa as a whole, the continent has far less food allergies and far less asthma than the United States or Europe.

There was an interesting study that was completed last year in Europe called the EUROPREVAL study, which looked at allergies on a country by country basis. And what was really surprising was even within Europe, Western Europe, with a lot of commerce between various countries and the close geographic proximity, there was a huge variation from country to country, even within country, where one part of a country would have a particularly high incidence of peanut or soy allergy, and that would be very different from the adjoining country or even different parts of the same country.

So there are a lot of factors involved. Again, the environment, genetics, pollution, so many – and diet. So many different factors can play a role.

CONAN: Let’s go next to Melissa, Melissa with us from Brick Township in New Jersey.

MELISSA (Caller): Hi. Good afternoon.

CONAN: Good afternoon. Go ahead, please.

MELISSA: Yeah. I had a question for the doctor. My daughter is one. I have four children. And about six months ago, I gave her an egg to eat, and I noticed that her ears were turning up purplish. And, of course, I called the pediatrician. And it looks like hives, so she ordered a blood panel of, I guess, food allergy test (unintelligible) drew serums. And they found out that she was not allergic to eggs, but she was allergic to peanuts and tuna fish, which I had never exposed her to and – so it must have been a fluke thing of why her ears, you know, had broken out in that rash.

But my concern is the sensitivity level. She marked that it wasn’t severe. I think she said it was level two, if I remember. I don’t know how it’s actually measured. But is this something that if I keep her away from it, she’s likely to grow out of in the future, or is this something that, you know, if I keep her from being around anything with peanuts in it…

CONAN: Mm-hmm. Melissa, I’m going to refer your question to Dr. Sharma. But we have to say he can’t diagnose your daughter on the radio. This is very broad, generalized response.

MELISSA: Yeah.

CONAN: But, Dr. Sharma.

Dr. SHARMA: Thanks. Well, Melissa, unfortunately, I can’t speak more than in general terms. But these blood tests are helpful both at the time of diagnosis as well as in terms of giving some information about prognosis. And so oftentimes, we will repeat blood tests annually, perhaps more frequently depending on a specific circumstance, to look at the trend in the level and that can sometimes give us some information about whether a child is outgrowing given food allergy or whether it’s persisting. And the gold standard as Dr. Fenton had already alluded to is to do an oral food challenge in a supervised setting where that food is actually fed to the child and you observe for any signs of a reaction.

CONAN: All right. And Dr. Fenton.

Dr. FENTON: I wanted to follow up on what Dr. Sharma was mentioning because it seems to make common sense to most people that avoiding a food for a child who might have an allergic sensitization is the right thing to do.

But actually there is a lot of evidence to support that early consumption of those foods can actually prevent a food allergy. For example, in Israel, a country where young children are traditionally given a peanut-containing snack called Bamba, these children have an amazingly low rate of peanut allergy compared to other countries.

So we’ve actually taken a look at that, and the NIAID is funding a study that is looking at whether consumption or avoidance of peanut in early life is more protective against the eventual development of peanut allergy.

CONAN: Melissa, good luck with your daughter. Appreciate it.

MELISSA: Thank you. Thank you.

CONAN: Here’s an email. This is from Karen. Thirty years ago, I had a massive anaphylactic reaction within 10 to 15 minutes after consuming shrimp. My husband rushed me to a nearby hospital that he worked for. We were met in the parking lot by staff with the epinephrine in hand. I had airway compromise, massive hives over my entire body, including face and oral mucosa. Of course, I went for allergy testing following this episode. And the allergist at the University of Cincinnati decided after an exhaustive period of testing, I was likely allergic to what the shrimp ate. I carried an EpiPen for years but no longer do, and I eat shrimp often.

The exhaustive series of tests, and Dr. Sharma, so many patients complain about that. Why can’t we find out what the diagnosis is more easily?

Dr. SHARMA: It’s a great question. And the testing is moving forward. And I think with funding from organizations like the NIAID, we’re getting more refined diagnostic testing. And, eventually, we will have testing that has greater sensitivity and specificity. The specific question regarding this food; hard to know what exactly happened. There are cases of anaphylaxis which we call idiopathic. That means that it wasn’t related to anything that was eaten or in the environment, and the immune system just did it on its own. But it certainly – our hope is that, with time, we’ll have even better diagnostic tools.

CONAN: Let’s go next to Nathan, Nathan with us from Berkeley.

NATHAN (Caller): Hi. Yeah. I have an awful lot of questions. But if I restrict myself to one, the symptoms that I get – I talked to various doctors at various times and they don’t even have a name for this reaction. And, you know, in my case, I get bleeding blisters in my sinuses in my nose. Or from cranberries, I get blisters on the back of my neck and the back of my hands. And I was wondering, is this something that is just completely unfamiliar to physicians?

CONAN: Dr. Fenton, has this come up in your experience?

Dr. FENTON: Well, I think I’ll pump that one to Dr. Sharma since I’m not a physician.

CONAN: All right.

Dr. SHARMA: It’s often that we’ll see patients who have a variety of vague complaints. And they’re wondering, or sometimes worrying that they might have a food allergy. And so sometimes our job is to say that we don’t think this is a food allergy. And oftentimes that happens more in adults because it is unusual if we would have a new onset of food allergy with the exception, perhaps, of fish – to fish or shellfish later in adulthood. But these kinds of vague complaints, it’s difficult to connect them directly to food allergy.

CONAN: Is it vague to say, every time I eat cranberries I get hives at the back of my hands and at the back of my neck?

Dr. SHARMA: Well, that particular reaction I wasn’t referring to. But the bleeding and the oral ulcers, that’s not something that we commonly see with any particular kind of immune media, that food allergy. Hives certainly are one sign of a food allergic reaction where the allergic cells under the skin are releasing their chemicals causing the hives. And that can happen after certain foods. Cranberries are not one of the top eight food allergens. And groups like the NIAID and FAAN, we really try to focus our emphasis on the top eight food allergens, which are responsible for more than 90 percent of food allergies.

CONAN: And those eight are?

Dr. SHARMA: So milk, eggs, soy, wheat, peanut, tree nuts, fish and shellfish.

CONAN: Okay. It sounds like you got that list memorized. Thank you very much for the call, Nathan. And good luck at Thanksgiving.

In any case, thanks to Dr. Sharma – Dr. Hemant Sharma of the Food Allergy Program at the Children’s National Medical Center in Washington, D.C. Matthew Fenton, I’m not going to read your title again. But he’s with the National Institute of Allergy and Infectious Diseases, and Julia Bradsher of the Food Allergy Anaphylaxis Network.

Posted on

FDA Orders Safety Studies for Asthma Drugs

The U.S. National Library of Medicine and National Institutes of Health is reporting that U.S. health regulators have ordered drugmakers to conduct clinical trials involving a total of 53,000 patients to test the safety of a controversial class of inhaled asthma drugs that are already on the market.

The trials are being required to demonstrate the safety of medicines known as long-acting beta-agonists (LABAs) when used in combination with inhaled steroids, another class of asthma drugs, the U.S. Food and Drug Administration said on Friday.

LABAs to be studied are AstraZeneca’s Symbicort, GlaxoSmithKline’s Advair Diskus, Merck & Co’s Dulera, and Novartis AG’s Foradil.

LABAs have long been under FDA scrutiny as they can increase the risk of severely worsening asthma symptoms that can lead to hospitalizations and death.

The drugs work by relaxing the muscles of the airways to help people breathe easier and are also used to treat the serious lung condition, chronic obstructive pulmonary disease

(COPD).

The FDA expects to receive results in 2017 for the studies that will begin later this year.

In four of the trials sought by the FDA, each of the LABAs plus a corticosteroid will be compared with the steroid alone in patients 12 years of age and older. Those studies are expected to include a total of 46,800 patients.

Some of these drugs. such as Advair and Symbicort, are combination drugs that include a LABA with a corticosteroid.

The agency has also asked for a trial of 6,200 younger patients, aged 4 to 11, using Glaxo’s Advair Diskus.

The huge size of the studies signals that FDA wants to be completely sure about the safety profile of these drugs as they are used so widely, Morningstar analyst Damien Conover said.

Such a large study population might pose some financial challenges for the drugmakers, he said.

“Glaxo is complying with the FDA request to implement the Phase 4 study,” Glaxo spokeswoman Lisa Behrens said of the post-marketing trial.

AstraZeneca said it was finalizing study protocol with the agency and supports efforts to address any questions regarding use of its drug.

Novartis said it was reviewing the post-marketing requirements issued by the FDA, while Merck said it would have a comment shortly.

The FDA last June issued warnings on LABAs, saying they should never be used on their own to treat asthma and called on drugmakers to conduct further studies to better understand the safety of LABAs when used with inhaled steroids.

The agency posted the study requirements on its website at http://www.fda.gov/Drugs/DrugSafety/ucm251512.htm