FDA Approves New Device for Adults with Severe and Persistent Asthma

The U.S. Food and Drug Administration today approved the first medical device that uses radiofrequency energy to treat severe and persistent asthma in certain adults.

The Alair Bronchial Thermoplasty System is intended for patients ages 18 and older whose severe and persistent asthma is not well-controlled with inhaled corticosteroids and long-acting beta agonist medications.

The device is composed of a catheter with an electrode tip that delivers a form of electromagnetic energy, called radiofrequency energy, directly to the airways. A controller unit generates and controls the energy.

Inflammation causes the airways of people who have asthma to swell and narrow, making breathing difficult. The Alair system treats asthma symptoms by using radiofrequency energy to heat the lung tissue in a controlled manner, reducing the thickness of smooth muscle in the airways and improving a patient’s ability to breathe. To benefit, patients will require multiple sessions targeting different areas in the lungs.

“The approval of the Alair system provides adult patients suffering from severe and persistent asthma with an additional treatment option for a disease that is often difficult to manage,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

The FDA based its approval on data from a clinical trial of 297 patients with severe and persistent asthma. The trial showed a reduction of severe asthma attacks with use of the Alair system.

The FDA is requiring a five-year post-approval study of the device to study its long-term safety and effectiveness. The device manufacturer, Asthmatx, will follow many of the patients who were enrolled in the clinical trial and enroll 300 new patients at several medical centers across the United States.

Possible side effects during the course of treatment may include asthma attacks, wheezing, chest tightness or pain, partially collapsed lung (atelectasis), coughing up blood (hemoptysis), anxiety, headaches, and nausea. The Alair system is designed to reduce the number of severe asthma attacks on a long-term basis. However, there is a risk of immediate asthma attacks during the course of the treatment.

The Alair system is not for use in asthma patients with a pacemaker, internal defibrillator, or other implantable electronic device. Also, those patients with known sensitivities to lidocaine, atropine, or benzodiazepines should not use the device. Alair has not been studied for success in retreatment of the same area of the lung. Currently, patients should not be retreated with the Alair system in the same area of the lung.

Asthma patients considering the Alair system should not be treated while the following conditions are present: an active respiratory infection, coagulopathy (bleeding disorder), asthma exacerbations, or if they have had changes to their corticosteroid regimen 14 days before the proposed treatment.

Asthmatx Inc. is based in Sunnyvale, Calif.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Follow us on Twitter:  @GAFrontPage

Asthma and COPD Inhalers That Contain Ozone-depleting CFCs to be Phased Out; Alternative Treatments Available

/PRNewswire/ -- The U.S. Food and Drug Administration today announced, in accordance with longstanding U.S. obligations under the Montreal Protocol on Substances that Deplete the Ozone Layer, seven metered-dose inhalers (MDI) used to treat asthma and chronic obstructive pulmonary disease (COPD) will be gradually removed from the U.S. marketplace. These inhalers contain ozone-depleting chlorofluorocarbons (CFCs), which are propellants that move medication out of the inhaler and into the lungs of patients. Alternative medications that do not contain CFCs are available.

The affected products and their phase out schedule include:

Last Date to be
                         manufactured, sold or
  Inhaler Medication     dispensed in U.S.      Manufacturer
  Tilade Inhaler
   (nedocromil)         June 14, 2010           King Pharmaceuticals
  Alupent Inhalation
   Aerosol                                       Boehringer Ingelheim
   (metaproterenol)     June 14, 2010            Pharmaceuticals
  Azmacort Inhalation
   Aerosol
   (triamcinolone)      Dec. 31, 2010           Abbott Laboratories
  Intal Inhaler
   (cromolyn)           Dec. 31, 2010           King Pharmaceuticals
  Aerobid Inhaler
   System
   (flunisolide)        June 30, 2011           Forest Laboratories
  Combivent Inhalation
   Aerosol (albuterol
   and ipratropium in                            Boehringer Ingelheim
   combination)         Dec. 31, 2013            Pharmaceuticals
  Maxair Autohaler                               Graceway
   (pirbuterol)         Dec. 31, 2013            Pharmaceuticals

Patients using the inhalers scheduled to be phased out should talk to their health care professional about switching to one of several alternative treatments currently available. Until then, patients should continue using their current inhaler medication.

CFCs are harmful because they deplete the ozone layer miles above the Earth that absorb some of the sun's harmful ultraviolet rays. The United States has banned the general use of CFCs in consumer aerosols for decades, and eliminated the production of CFCs in the United States as of Jan. 1, 1996, except for certain limited uses, such as MDIs.

"During this transition, FDA wants to ensure that patients have access to safe and effective alternative medications to treat their asthma or COPD," said Badrul Chowdhury, M.D., Ph.D., director of the Division of Pulmonary, Allergy, and Rheumatology Products in FDA's Center for Drug Evaluation and Research. "We are currently working with professional societies and patient organizations to make sure patients understand which products will no longer be available and have information on which alternative medication might work best for them."

The CFC phase out is part of an international agreement to ban substances that deplete the Earth's ozone layer. The Montreal Protocol on Substances that Deplete the Ozone Layer and the U.S. Clean Air Act aim to protect the public health and the environment from the potentially negative effects of ozone depletion. Bans on products containing CFCs began in the late 1970s.

The decision to phase out the products is the latest in a series of decisions related to the removal of CFC inhaler products from the market as required by the Clean Air Act. The agency proposed to phase-out the seven remaining products in 2007 and reached a final decision after reviewing more than 4,000 public comments and information submitted as part of a public meeting.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Follow us on Twitter:  @GAFrontPage

FDA Announces New Safety Controls for Long-Acting Beta Agonists, Medications Used to Treat Asthma

The U.S. Food and Drug Administration today announced that drugs in the class of long-acting beta agonists (LABAs) should never be used alone in the treatment of asthma in children or adults. Manufacturers will be required to include this warning in the product labels of these drugs, along with taking other steps to reduce the overall use of these medications.

These new requirements are based on FDA analyses of clinical trials showing that use of these long-acting medicines is associated with an increased risk of severe worsening of asthma symptoms, leading to hospitalization in both children and adults and death in some patients with asthma. The drugs involved include the single agent products Serevent and Foradil and combination medications Advair and Symbicort that also contain inhaled corticosteroids. These medications improve a patient’s ability to breathe freely and reduce the symptoms of asthma by relaxing muscles in the lung’s airways.

The FDA will now require that the product labels reflect the following:

* The use of LABAs is contraindicated without the use of an asthma controller medication such as inhaled corticosteroid. Single-agent LABAs should only be used in combination with an asthma controller medication; they should not be used alone;
* LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications;
* LABAs should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved. Patients should then be maintained on an asthma controller medication.
* Pediatric and adolescent patients who require a LABA in addition to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA to ensure compliance with both medications.

“Although these medicines play an important role in helping some patients control asthma symptoms, our review of the available clinical trials determined that their use should be limited, whenever possible, due to an increased risk of asthma exacerbations, hospitalizations and death,” said Badrul Chowdhury, M.D., director of the Division of Pulmonary and Allergy Products in the FDA’s Center for Drug Evaluation and Research.

“The risks of hospitalization and poor outcomes are of particular concern for children; parents need to know that their child with asthma should not be on a LABA alone,” said Dianne Murphy, M.D., director of the FDA’s Office of Pediatric Therapeutics.

LABAs are approved to treat both people with asthma or with chronic obstructive pulmonary disease (COPD). The new recommendations only apply to the use of LABAs in the treatment of asthma.

The FDA will be requiring the manufacturers of LABAs to conduct additional studies to further evaluate the safety of LABAs when used in combination with inhaled corticosteroids. The FDA will seek input on the design of these studies at a public advisory committee meeting in March 2010.

In addition to these actions, FDA will work with public and private partners under the agency’s ongoing Safe Use Initiative to study LABA prescribing practices.

“We will collaborate with our Safe Use partners to evaluate whether prescribing patterns adjust to the new recommendations for this class of asthma drugs. If prescribing patterns don’t adjust, we will determine the reasons and consider additional steps to support safe prescribing,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

The Safe Use Initiative, launched in November, strives to reduce preventable harm by identifying specific, preventable medication risks and developing, implementing and evaluating cross-sector interventions with public and private partners who are committed to safe medication use.

Advair and Serevent are marketed by Collegeville, PA-based GlaxoSmithKline.
Foradil is marketed by Lebanon, PA-based Novartis AG.
Symbicort is marketed by Wilmington, DE-based AstraZeneca.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Follow us on Twitter: @GAFrontPage

Researchers Find Common Respiratory Virus Hijacks Lung Cells to Stay Alive

/PRNewswire/ -- Approximately one-half of all infants are infected with the respiratory syncytial virus (RSV) during the first year of life, and almost all children have been infected at least once by the time they reach their second birthday. Researchers at West Virginia University have discovered what makes RSV such a severe and persistent illness.

Senior author Giovanni Piedimonte, M.D., and his team have discovered that RSV prompts the release of a molecule that keeps the invaded cells alive despite the infection. The mechanism allows infected cells to survive for a longer period of time while they continue to produce viral particles, thus contributing to the severity and persistence of the infection.

Research results are published in the current issue of the journal PLoS ONE.

Inflammation of the airways caused by RSV often results in wheezing, cough and respiratory distress, creating the most common respiratory infection in infancy or childhood. Each year, an estimated 125,000 infants in the United States are hospitalized with RSV, the leading cause of infant hospitalization.

"There is still no effective therapy or medical treatment for RSV infection. While often mild, it still is responsible for the deaths of hundreds of infants in the United States each year," said Dr. Piedimonte, chair of the WVU Department of Pediatrics and physician-in-chief of WVU Children's Hospital. "The virus also strikes in nursing homes and causes deaths in the elderly population, so understanding how it works is critical."

Piedimonte said up to 500 infants may die of the infection each year. RSV may also predispose children to long-term health problems such as asthma. Other groups at high risk for severe RSV disease include the elderly, adults with underlying respiratory or cardiac disease, and those with a compromised immune system.

"Viruses must find a way to survive inside the host, and in this case RSV has found a way of keeping alive the cells that they infect," Piedimonte explained. "The virus invades the cell, which then produces a small molecule called NGF, or nerve growth factor. NGF allows the cell to survive while the virus reproduces itself. Finally, the cell explodes releasing new viral particles ready to infect the neighboring cells."

In determining how the virus instructs the infected cell to prolong its life, the researchers may have established a blueprint for development of new anti-viral drugs aimed at interfering with the action of NGF, Piedimonte said. He added that RSV may prefer the lower respiratory tract specifically because the smaller airways there allow for more efficient production of NGF.

"The interesting part of the RSV infection is that the viruses induce NGF production within an hour of coming into contact with the human cells - that is, even before they start multiplying," said the paper's lead author, Sreekumar Othumpangat, Ph.D., a researcher in the WVU Pediatric Research Institute.

Children born prematurely as well as those with chronic lung or heart disease are at higher risk for severe RSV infections.

The laboratory studies were done using human cells. Now that Piedimonte's team has discovered how RSV prolongs the life of its host cell, they are proceeding with other studies to see if they can pinpoint the same mechanism in common cold and influenza viruses.

The paper's other authors are Laura F. Gibson, deputy director of the Mary Babb Randolph Cancer Center at WVU, and Lennie Samsell, a research assistant in the Pediatric Research Institute.

The article, "NGF Is an Essential Survival Factor for Bronchial Epithelial Cells during Respiratory Syncytial Virus Infection," is available online at http://dx.plos.org/10.1371/journal.pone.0006444.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

FDA Reviewing Preliminary Safety Information on Asthma Drug Xolair

The U.S. Food and Drug Administration announced today that it is conducting a safety review of Xolair (omalizumab), a drug used to treat certain adults and adolescents with moderate-to-severe persistent asthma.

Reviewers are looking for a possible association between patients who use Xolair and an increased risk of heart attack, abnormal heart rhythm, heart failure, and stroke. The possible association has been identified based on interim results from an ongoing study of Xolair known as Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS). The study is being conducted by the manufacturer, San Francisco-based Genentech Inc.

An FDA Early Communication is available online.

The Early Communication is in keeping with the FDA’s commitment to inform the public about its ongoing safety reviews of drugs. Once its review is completed, the FDA will communicate its findings and any resulting recommendations to the public. Until the evaluation is completed, health care professionals and patients should be aware that the agency is reviewing data that may suggest a risk of adverse events. The FDA is not advising a change in prescribing or use of the drug.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

FDA Requests Labeling Change for Leukotriene Modifiers

The U.S. Food and Drug Administration today provided further updated safety information on a class of asthma drugs known as leukotriene modifiers. The FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling) regarding neuropsychiatric events (behavior, mood changes) that have been reported in some persons taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR).

Leukotrienes are chemicals the body releases in response to an inflammatory stimulus, such as when a person breathes in an allergen. Montelukast and zafirlukast are leukotriene receptor antagonists that work by blocking leukotrienes. Zileuton is a leukotriene synthesis inhibitor which works by stopping the formation of certain substances that cause swelling, tightening, and mucus production in the airways.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

Folic Acid May Help Treat Allergies, Asthma

Folic acid, or vitamin B9, essential for red blood cell health and long known to reduce the risk of spinal birth defects, may also suppress allergic reactions and lessen the severity of allergy and asthma symptoms, according to new research from the Johns Hopkins Children's Center.

In what is believed to be the first study in humans examining the link between blood levels of folate -- the naturally occurring form of folic acid -- and allergies, the scientists say results add to mounting evidence that folate can help regulate inflammation. Recent studies, including research from Johns Hopkins, have found a link between folate levels and inflammation-mediated diseases, including heart disease. A report on the Johns Hopkins Children's findings appears online ahead of print in the Journal of Allergy & Clinical Immunology.

Cautioning that it's far too soon to recommend folic acid supplements to prevent or treat people with asthma and allergies, the researchers emphasize that more research needs to be done to confirm their results, and to establish safe doses and risks.

Reviewing the medical records of more than 8,000 people ages 2 to 85 the investigators tracked the effect of folate levels on respiratory and allergic symptoms and on levels of IgE antibodies, immune system markers that rise in response to an allergen. People with higher blood levels of folate had fewer IgE antibodies, fewer reported allergies, less wheezing and lower likelihood of asthma, researchers report.

"Our findings are a clear indication that folic acid may indeed help regulate immune response to allergens, and may reduce allergy and asthma symptoms," says lead investigator Elizabeth Matsui, M.D., M.H.S., pediatric allergist at Johns Hopkins Children's. "But we still need to figure out the exact mechanism behind it, and to do so we need studies that follow people receiving treatment with folic acid, before we even consider supplementation with folic acid to treat or prevent allergies and asthma."

The current recommendation for daily dietary intake of folic acid is 400 micrograms for healthy men and non-pregnant women. Many cereals and grain products are already fortified with folate, and folate is found naturally in green, leafy vegetables, beans and nuts.

Other findings of the study:

People with the lowest folate levels (below 8 nanograms per milliliter) had 40 percent higher risk of wheezing than people with the highest folate levels (above 18 ng/ml).
People with the lowest folate levels had a 30 percent higher risk than those with the highest folate levels of having elevated IgE antibodies, markers of allergy predisposition.
Those with the lowest folate levels had 31 percent higher risk of atopy (allergic symptoms) than people with the highest folate levels.
Those with lowest folate levels had 16 percent higher risk of having asthma than people with the highest folate levels.
Blacks and Hispanics had lower blood folate levels - 12 and 12.5 nanograms per milliliter, respectively - than whites (15 ng/ml), but the differences were not due to income and socio-economic status.

The Johns Hopkins team is planning a study comparing the effects of folic acid and placebo in people with allergies and asthma.

Asthma affects more than 7 percent of adults and children in the United States, and is the most common chronic condition among children, according to the Centers for Disease Control and Prevention. Environmental allergies are estimated to affect 25 million Americans, according to the CDC.

Co-investigator on the study: William Matsui, M.D, of the Johns Hopkins Kimmel Cancer Center.

The research was funded by the National Institutes of Health.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

Asthma Sufferers Breathe Easier as Walmart Announces $9 Environmentally Sustainable Inhaler

/PRNewswire-FirstCall/ -- As part of its continued commitment to provide accessible, affordable medications to those who need it most, Walmart today announced it will carry an environmentally friendly albuterol rescue inhaler starting at $9, the lowest-priced inhaler on the market. The ReliOn(R) Ventolin HFA inhalers, sold exclusively at Walmart*, will ease the transition as asthma sufferers are forced to replace their CFC-powered inhalers with new HFA inhalers in the new year to comply with an FDA mandate.

"While some HFA inhalers may sell for as much as $60 for certain brands, our $9 ReliOn Ventolin HFA inhaler will ease the financial burden for sufferers of asthma who should not go without these life-saving medications," said Sandy Kinsey, Walmart's divisional merchandise manager for pharmacy. "As an advocate for our customers, we're committed to ensuring they have access to affordable medicine they cannot live without."

According to the 2007 National Institutes of Health (NIH) asthma treatment guidelines, overuse of albuterol is a sign of uncontrolled asthma. With 60 metered inhalations, the ReliOn Ventolin HFA inhaler helps both patients and health care professionals monitor and track usage via the dose counter to identify overuse of albuterol. Additionally, it helps patients track how many puffs remain in their inhaler so they do not run out of their rescue medication when they need it most.

Walmart offers other affordable medications* for those suffering from the disease, including:

Albuterol 2mg tab $4 for 90 tablets $10 for 270 tablets
Albuterol 4mg tab $4 for 60 tablets $10 for 180 tablets
Albuterol 2mg/5ml syrup $4 for 120ml $10 for 360ml


For further information about Walmart's affordable prescription program, customers can visit http://www.walmart.com/pharmacy or discuss the program with their local Walmart, Neighborhood Market or Sam's Club pharmacist.

* Products and pharmacies are not available in North Dakota

-----
www.fayettefrontpage.com
Fayette Front Page
Community News You Can Use
Fayetteville, Peachtree City, Tyrone
www.georgiafrontpage.com
Georgia Front Page

Mayo Clinic Study Finds Increased Risk of Pneumococcal Disease in Asthma Patients

/PRNewswire-USNewswire/ -- Mayo Clinic research shows adults with asthma are at increased risk of serious pneumococcal disease caused by Streptococcus pneumoniae, the most common bacteria causing middle ear infections and community acquired pneumonia. It also causes blood stream infections and brain infections. According to the Centers for Disease Control, pneumococcal infection is one of the leading causes of death from a vaccine-preventable disease. The researchers recommend including asthma as an indication for pneumococcal vaccination in adults. The results of the study were recently published in the October edition of the Journal of Allergy and Clinical Immunology.

"We found that adults with invasive pneumococcal disease, a serious, potentially fatal disease, are seven times more likely to be asthmatics. Our study also showed that 17 percent of the burden of invasive pneumococcal disease can be attributable to asthma at a population level. This is quite a significant impact on the burden of invasive pneumococcal disease," says Young Juhn, M.D., a pediatric and adolescent medicine physician-scientist at Mayo Clinic and lead author of the study. "Invasive pneumococcal disease is a vaccine-preventable disease. The implication is that we have the ability to significantly reduce instances of this potentially fatal disease by expanding the indication for the pneumococcal vaccine to include adults with asthma."

Researchers used a population-based, retrospective case-control study of 3,941 records from the Rochester, Minn. population to see if there was a higher incidence of pneumococcal disease among people with asthma. Adults diagnosed with asthma were almost seven times more likely to develop invasive pneumococcal diseases than adults who were not diagnosed with asthma. In children the sample size for was not large enough to draw a definitive conclusion.

"The Advisory Committee on Immunization Practices (ACIP), which is the governing body for immunization practices in the United States, voted unanimously to include asthma as a pneumococcal vaccine condition at the recent ACIP meeting in October, 2008. Adults with asthma should receive the pneumococcal vaccine," says Dr. Juhn.

Further research implications include finding out why a connection exists between instances of pneumococcal disease and asthma, determining whether the connection between asthma and this particular bacterial infection also exists with other bacterial infections, such as pertussis (whooping cough), and the connection between asthma and other non-infectious diseases, such as inflammatory bowel disease, juvenile diabetes, and rheumatoid arthritis. Dr. Juhn does not believe all asthmatic patients react the same way. He is looking for a subset of asthmatic patients who have an increased susceptibility to microbial infection.

Study authors, in addition to Dr. Juhn, include Hirohito Kita, M.D., Department of Allergic Diseases Research, Mayo Clinic; Barbara Yawn, M.D., Department of Epidemiology, Mayo Clinic; Thomas Boyce, M.D., Department of Pediatric Infectious Diseases, Mayo Clinic; Kwang Yoo, M.D., Ph.D., Department of Internal Medicine, Kunkook University, Republic of Korea; Michaela McGree, Department of Biostatistics, Mayo Clinic; Amy Weaver, Department of Biostatistics, Mayo Clinic; Peter Wollan, Ph.D., Department of Epidemiology, Mayo Clinic; and Robert Jacobson, M.D., Department of Pediatric and Adolescent Medicine, Mayo Clinic.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

CDC Study Finds 3 Million U.S. Children have Food or Digestive Allergies

The number of young people who had a food or digestive allergy increased 18 percent between 1997 and 2007, according to a new report by the Centers for Disease Control and Prevention. In 2007, approximately 3 million U.S. children and teenagers under age 18 – or nearly 4 percent of that age group – were reported to have a food or digestive allergy in the previous 12 months, compared to just over 2.3 million (3.3 percent) in 1997.

The findings are published in a new data brief, “Food Allergy Among U.S. Children: Trends in Prevalence and Hospitalizations.” The data are from the National Health Interview Survey and the National Hospital Discharge Survey, both conducted by CDC′s National Center for Health Statistics.

The report found that eight types of food account for 90 percent of all food allergies: milk, eggs, peanuts, tree nuts, fish, shellfish, soy, and wheat. Reactions to these foods by an allergic person can range from a tingling sensation around the mouth and lips, to hives and even death, depending on the severity of the reaction.

Children with food allergy are two to four times more likely to have other related conditions such as asthma and other allergies, compared to children without food allergies, the report said.
Other highlights:

* Boys and girls had similar rates of food allergy – 3.8 percent for boys and 4.1 percent for girls.
* Approximately 4.7 percent of children younger than 5 years had a reported food allergy compared to 3.7 percent of children and teens aged 5 to 17 years.
* Hispanic children had lower rates of reported food allergy (3.1 percent) than non-Hispanic white (4.1 percent) or non-Hispanic black children (4 percent.)
* In 2007, 29 percent of children with food allergy also had reported asthma compared to 12 percent of children without food allergy.
* Approximately 27 percent of children with food allergy had reported eczema or skin allergy, compared to 8 percent of children without food allergy.
* Over 30 percent of children with food allergy also had reported respiratory allergy, compared with 9 percent of children with no food allergy.
* From 2004 to 2006, there were approximately 9,537 hospital discharges per year with a diagnosis related to food allergy among children from birth to 17 years. Hospital discharges with a diagnosis related to food allergy increased significantly over time between 1998-2000 through 2004-2006.

The mechanisms by which a person develops an allergy to specific foods are largely unknown. Food allergy is more prevalent in children than adults. Most affected children will outgrow food allergies, although food allergy can be a lifelong concern.

The full report is available at www.cdc.gov/nchs.

-----
www.fayettefrontpage.com
Fayette Front Page
Community News You Can Use
Fayetteville, Peachtree City, Tyrone
www.georgiafrontpage.com
Georgia Front Page

Teleflex Medical Introduces the Neb-U-Mask for the Treatment of Acute Asthma Exacerbations

(BUSINESS WIRE)--Teleflex Medical, a leading global supplier of disposable products for critical care and surgical applications, has received clearance from the FDA to market the Hudson RCI Neb-U-Mask®, a respiratory device that allows for the concurrent delivery of aerosolized medication and a high concentration of medical gases to treat acute asthma exacerbations.

Asthma is a chronic inflammatory disease of the airways. According to the National Asthma Education and Prevention Program, asthma affects more than 22 million people in the United States, and is one of the most chronic childhood diseases. It is estimated that asthma accounts for approximately 1 in every 250 deaths worldwide. Many of the deaths are preventable. Despite current available therapy with the use of bronchodilators and corticoids, alleviation of obstruction may not occur rapidly enough to prevent ventilatory failure and endotracheal intubation.

During an acute asthma attack, a patient may be given oxygen or heliox in combination with pharmacologic therapies. The challenge of this treatment approach is the lack of a device that allows for the simultaneous delivery of medical gases and aerosolized medication. In a study published in the Annals of Emergency Medicine in 2002, low oxygen saturation has been correlated inversely with the rate of hospitalization1, which puts caregivers in a difficult situation when faced with the choice of medication delivery over an interruption of high levels of oxygen therapy.

The Neb-U-Mask addresses this unmet clinical need by allowing the concurrent delivery of aerosolized medications and high concentrations of oxygen or heliox. The system is composed of an innovative wye design, featuring a nebulizer connection and MDI adaptor, a non-rebreathing mask with a 750ml gas reservoir bag, and color coded tubing. This patented design promotes positive patient outcomes by avoiding therapy interruption. The nebulizer connection features a valved port, which maintains a closed system when a nebulizer is not in use. This closed system design allows for delivery of high levels of oxygen or heliox gas mixtures.

“We are pleased to add the Neb-U-Mask to our extensive line of asthma management solutions,” said Whitney Reynolds, director of respiratory care marketing. “At Teleflex Medical our ultimate goal is to provide products and education programs to help patients with asthma live a normal, healthy, and productive life. But knowing that acute asthma attacks are prevalent, we must provide caregivers the tools they need to achieve positive patient outcomes.”

The system is available for sale today in both adult and pediatric versions. The system is conveniently packaged with a Micro Mist® nebulizer, allowing for a “grab and go” response in an emergency situation.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

Scientists Identify How Gastric Reflux May Trigger Asthma

Researchers at Duke University Medical Center appear to have solved at least a piece of a puzzle that has mystified physicians for years: why so many patients with asthma also suffer from GERD, or gastroesophageal reflux disease.

Clinicians first noted a relationship between the two diseases in the mid-1970s. Since then, studies have shown that anywhere from 50 to 90 percent of patients with asthma experience some aspect of GERD. But can GERD cause asthma, or, is it the other way around? Perhaps there is some shared mechanism at the root of both disorders causing them to arise together. Physicians could make a case for each scenario, but until now, the exact nature of the relationship was not clear.

Working in laboratory experiments with mice, Dr. Shu Lin, an assistant professor of surgery and immunology at Duke, discovered that inhaling tiny amounts of stomach fluid that back up into the esophagus – a hallmark of GERD – produces changes in the immune system that can drive the development of asthma.

In the experiments, researchers inserted miniscule amounts of gastric fluid into the lungs of mice (mimicking the human process of micro-aspiration, or breathing in tiny amounts) over a period of eight weeks. They compared these animals' immune systems with those of mice that were exposed to allergens but not the gastric fluid.

The immune systems of the two sets of mice responded very differently. Those that had the gastric fluid in their lungs developed what researchers call a T-helper type 2 response, a type of immune system reaction characteristic of asthma. The other mice responded in a more balanced manner, mounting an immune reaction consisting of both T-helper type 1 and T-helper type 2 responses.

"This is the first experimental evidence in a controlled, laboratory setting linking these two very common conditions in humans," says Lin, the senior author of the study published online in the European Journal of Clinical Investigation. "These data suggest that chronic micro-aspiration of gastric fluid can drive the immune system toward an asthmatic response."

"This does not mean that everyone with GERD is going to develop asthma, by any means," says William Parker, an assistant professor of surgery at Duke and a co-author of the study. "But it may mean that people with GERD may be more likely to develop asthma. If there is an upside to this, it is that developing GERD is something we can pretty much treat and control."

Parker says poor diet, a lack of exercise and obesity all contribute to the development of GERD, and that rising rates of reflux disease are part of a "perfect storm" of environmental and behavioral factors driving escalating rates of asthma, particularly in Western cultures. "People should avoid the risk factors for GERD. We strongly believe that the rise in asthma, particularly among adults in the country, is in large measure due to lifestyle choices that can be changed."

Lin and Parker agree that much more work needs to be done to fully understand the cellular and molecular mechanisms involved in the relationship between reflux disease and asthma, but both feel their study offers new directions for developing additional treatment options for both problems.

Lin says patients who already have GERD can minimize gastric reflux – and thereby lessen their chances of developing asthma – by following a few simple guidelines: Eat smaller meals and eat several hours before going to bed; raise the head of the bed a few inches; maintain a healthy weight; and limit fatty goods, coffee, tea, caffeine and alcohol – they can relax the esophageal sphincter and make reflux more likely.

Funding for the study came from the Society of American Gastrointestinal Endoscopic Surgeons Research Grant and the Parks Protocol Memorial Fund.

Additional co-authors from Duke include lead author Andrew Barbas, Tacy Downing, Keki Balsara, Hung-Enn Tan, Gregory Rubinstein, Zoie Holzknecht, Bradley Collins and R. Duane Davis.

Note to Pediatricians: Taper Meds in Kids with Stable Asthma

A study of how pediatricians prescribe asthma medications suggests that while most would readily increase a child’s medication if needed, many are reluctant to taper off drug use when less might be best. A report on the study, led by Johns Hopkins Children’s Center researchers, appears in the July issue of Pediatrics.

“Asthma medications can have serious, albeit infrequent, side effects, and while under-treatment is undeniably a big problem, not stepping down treatment when a child is doing well may be too,” says lead investigator Sande Okelo, M.D., an asthma specialist at Hopkins Children’s.

In the research, conducted among 310 pediatricians nationwide, 40 percent said they would not step down high-dose treatment even if a child’s symptoms were well controlled and infrequent.

“If a child is doing well and her symptoms are well under control, why not take that chance and see if a smaller dose would do the trick?” says senior investigator Gregory Diette, M.D., M.H.S., a lung specialist at Hopkins.

Beyond side effects, Okelo says, a failure by pediatricians to taper off drugs may also lead parents to do so on their own by skipping doses or decreasing them.

“Past research shows that when parents are concerned about side effects and their child is doing well, they may take action without a doctor’s approval,” Okelo says.

For the study, the pediatricians were asked to devise treatment plans using different patient scenarios, describing various elements, including whether a child had been hospitalized recently, how bothersome and frequent a child’s symptoms were, whether symptoms had recently intensified or lessened and whether the child had wheezing on a physical exam. Most doctors reported they would step up treatment in patients with:

recent hospitalizations
frequent symptoms
parents who said they were bothered by their child’s symptoms
those who had wheezing on exam
While current treatment guidelines focus on symptom frequency, nearly all pediatricians reported using multiple factors in their decision-making, including quality of life and how bothered parents were by their child’s symptoms.

Okelo says pediatricians might greatly benefit from a step-by-step, “frontlines” tool that tells them how to specifically apply treatment guidelines and how to use different dimensions of the disease in their day-to-day practice.

Because asthma is an unstable disease and can change often and unpredictably, it is essential that children with asthma get regular follow-up exams every three to six months even in the absence of symptoms, researchers recommend.

Asthma is the most common pediatric chronic illness, affecting 6.5 million children in the United States, according to the Centers for Disease Control and Prevention.

The study was funded by the National Heart, Lung and Blood Institute.

Other Hopkins investigators on the study: Cecilia Patino, M.D., Kristin Riekert, Ph.D., Barry Merriman, M.A., Andrew Bilderback, B.S., Nadia Hansel, M.D., M.P.H., Kathy Thompson, R.N., Jennifer Thompson, M.P.H. and Cynthia Rand, Ph.D. Other institutions involved in the study include Howard University, Washington, D.C.

Link Shown Between Thunderstorms and Asthma Attacks in Metro Atlanta Area by Team of Researchers from University of Georgia and Emory University

In the first in-depth study of its kind ever done in the Southeastern United States, researchers at the University of Georgia and Emory University have discovered a link between thunderstorms and asthma attacks in the metro Atlanta area that could have a “significant public health impact.”

While a relationship between thunderstorms and increased hospital visits for asthma attacks has been known and studied worldwide for years, this is the first time a team of climatologists and epidemiologists has ever conducted a detailed study of the phenomenon in the American South.

The team, studying a database consisting of more than 10 million emergency room visits in some 41 hospitals in a 20-county area in and around Atlanta for the period between 1993 and 2004, found a three percent higher incidence of visits for asthma attacks on days following thunderstorms.

“While a three percent increase in risk may seem modest, asthma is quite prevalent in Atlanta, and a modest relative increase could have a significant public health impact for a region with more than five million people,” said Andrew Grundstein, a climatologist in the department of geography at UGA and lead author on the research. Grundstein went on to say that “three percent is likely conservative because of limitations in this study.”

The next step for the UGA and Emory team will be, for the first time, to apply Doppler radar, modeling and observational data to the “thunderstorm asthma” problem based on what Grundstein calls an intriguing initial finding. He points out that “radar data coupled with the metro Atlanta database will allow us to correlate thunderstorm-asthma interactions that we are probably missing today.”

Paige Tolbert, professor and chair of the department of environmental and occupational health in the Rollins School of Public Health at Emory and a co-author of the just-published study, said the expertise of the two universities came together strongly in studying the problem.

“The Emory team has experience with a comprehensive emergency department database, and the UGA team can provide a much more refined characterization of thunderstorms than was performed in the previous studies of this question,” she said. “The study will thus provide new insight into the mechanisms under the phenomenon of thunderstorm-induced asthma.”

The research was published in the online edition of the medical journal Thorax. Other authors of the paper include: Marshall Shepherd and Thomas Mote from the UGA department of geography; Luke Naeher from the UGA department of environmental health science; and Stefanie Ebelt Sarnat and Mitchell Klein, who along with Tolbert are from the department of environmental and occupational health in the Rollins School of Public Health at Emory.

About 20 million Americans have asthma, according to the American Academy of Allergy, Asthma and Immunology. There also has been a dramatic increase in reported cases of the disease, with its prevalence increasing 75 percent between 1980 and 1994. Some 5,000 Americans die annually from asthma attacks.

Approximately 210,000 Georgia children under the age of 17 have asthma, according to the Division of Public Health of the Georgia Department of Human Resources. Some 65 percent of that number had an attack within the last year.

While associations between thunderstorm activity and asthma deaths and emergency room visits have been reported around the world, virtually no studies have been done in the American South, where hundreds of thousands suffer from asthma and thunderstorms are prevalent.

Some people may find it odd that thunderstorms, which supposedly “clear the air” of pollen and pollutants, are implicated in asthma attacks. The most prominent hypothesis as to why it happens, the authors of the paper say, is that “pollen grains may rupture upon contact with rainwater, releasing respirable allergens, and that gusty winds from thunderstorm downdrafts spread particles . . . which may ultimately increase the risk of asthma attacks.”

The team used thunderstorm occurrences from meteorological data gathered at Atlanta’s Hartsfield-Jackson International Airport and compared that information with the vast database of emergency room visits to arrive at the figure of a three percent increase in asthma-related emergency room visits following thunderstorms for the study period.

In all, during the 11-year period, there were 564 thunderstorm days, and in order to better understand the physical mechanisms that relate thunderstorms and asthma, the team also mined the information on total daily rainfall and maximum five-second wind gusts, which they used as “a surrogate for thunderstorm downdrafts and to indicate the maximum wind speed of the storm.”

In all, there were 215,832 asthma emergency room visits during the period and 28,350 of these occurred on days following thunderstorms. While the new study is the first of its kind in the South and does clearly indicate a relationship between thunderstorms and asthma in the metro Atlanta area, much more work remains, Grundstein said.

“Obtaining a better understanding of the mechanistic basis of the phenomenon of thunderstorm-induced asthma will allow for better intervention strategies and improved emergencies services planning,” said Stefanie Ebelt Sarnat of Emory. “This will be particularly important in the era of climate change.”

Grundstein added that in the Atlanta area conditions favorable for an estimated doubling of severe thunderstorms are expected within this century.

By Philip Lee Williams
University of Georgia

Mayo Clinic Researchers Aim to Improve Asthma Patients' Care Through Computer-based Simulation Program

mdash - Mayo Clinic pulmonary researchers have designed and tested a new patient education computer program intended to help people with asthma manage their disease. The program allows asthma patients (an estimated 7 percent of the U.S. adult population) to practice making key decisions in a safe, simulated environment.

The Mayo Clinic group will present results of a study assessing users' experiences at the American Thoracic Society's 2008 International Conference in Toronto.

To improve delivery of asthma patient education messages, the Mayo team created a user-friendly tool called CASPER (Computerized Asthma Self-management Program and Educational Resource for adults). CASPER is an interactive story-based, Web-enabled asthma simulation program to enhance patients' ability to consistently treat their asthma. To progress through CASPER, patients answer questions displayed on the screen following a simulated asthma-attack scenario, such as "Bob's Night Time Wakening." The scenario portrays a familiar asthma event in pictures and text, and asks patients how to treat it. In response to the choice they enter on the computer, patients receive a comment that explains the best action to take in the story scenario, as well as why the other choices are not as effective.

This type of education is needed, researchers say, because learning how to manage asthma can be challenging for patients. They have a range of triggering events to anticipate, varied medications to take, and multiple methods for doing so, such as choosing from among long-term steroids, quick-relief inhalers and over-the-counter medications.

Patient self-management of asthma requires intensive education, says Kaiser Lim, M.D., a specialist in pulmonary and critical care medicine and lead researcher on the project. "Imagine if we are able to empower our patients by simulation and have them learn vicariously," he says. "We envision that this phase of patient education will come after the initial teaching sessions, and it will allow patients to synthesize all the information we have imparted."

Overall, the computer-based experience was positive for users, Dr. Lim says, showing promise as a tool that can help manage disease and control medical costs. "It is well documented that there is an increasing need for innovative educational programs for chronic disease self-management," he says. "But before we can judge the efficacy of this approach, the usability of these programs must be systematically and rigorously evaluated, and that's what we've begun to do with CASPER."

This story-based Web-based simulation approach to patient education holds high potential for improving management of other diseases as well. It can be used to address other pressing health problems, such as how to manage insulin, perform exercise, make food choices, and monitor hypertension and congestive heart failure, Dr. Lim says.

About CASPER

To assess the effectiveness of this educational approach, the Mayo researchers recruited 20 patients who had been diagnosed with asthma. The study articipants used the computer program with minimal instruction while a usability expert evaluated ease of use. More data from the patients' experience was gathered through surveys after patients used the omputer program and from brief interviews about the experience.

Reaction to CASPER

Results from observing and interviewing asthma patients using the computer education program show that CASPER's strengths include its:

* Story-based format. Patients generally found the narratives engaging, enjoyable and easy to f ollow.

* Use of Q&A structure. This organizational technique helped clarify messages.

* Ease of navigation. Even without instruction from a person on how to use the computer program, patients generally progressed as intended through the sequence of educational messages.

* Completion rate. Most users finished each asthma scenario as intended.

Researchers also found that several design elements of CASPER need further refinements, such as preventing detours from the intended messages through hyperlinks that distract from the delivery of a consolidated message.

Conclusions

The research demonstrated two main points about improving the effectiveness of patient-centered, computer-based education programs for adult asthma patients:

* Usability guidelines aren't enough to assure optimal use. Target-audience testing is required, too. Even when the components of design were based on established usability principles, the resulting application still had to be tested by the target audience to fine-tune its operation. Barriers to optimal utilization that emerged in target-audience testing included navigational issues, screen layout, consistency in content and design.

* A story-based, question-and-answer format is effective and helpful in the patient-centered, computer-based education setting for teaching adults about asthma management. Study participants confirmed the desirability of this approach, reporting that they found the program educational, engaging and entertaining.

Collaboration and Support

Other members of the Mayo Clinic research team are Kristin Vickers Douglas, Ph.D.; Marie Ivnik; Thomas Suther and Julie Hathaway. Montgomery Flinsch and his web team collaborated on the project. Their work was supported by the Mayo Foundation for Medical Education and Research.