Posts filed under 'Asthma'
Allergic Rhinitis Associated With Decline In Work And School Performance
Allergic rhinitis (AR), more commonly known as “hay fever” can have a profound impact on the daily lives of sufferers beyond its physical effect — including psychological well-being, sleep quality, and ability to learn and process cognitive input, according to a new article scheduled to appear in the on-line issue of Allergy and Asthma Proceedings.
“The Burden of Allergic Rhinitis,” authored by Robert A. Nathan, M.D., Clinical Professor of Medicine, Department of Internal Medicine, Division of Allergy and Immunology, University of Colorado Health Sciences Center, provides an overview of the impact of AR in our society based on findings in the landmark 2006 Allergies in America Survey (AIA) and other noteworthy surveys and studies conducted in the US and Europe. In his article, Dr. Nathan describes the negative cascade of events that adults and children can experience as a result of this condition.
“Nasal congestion profoundly affects quality of life, largely by undermining the restorative power of sleep. Poor-quality sleep leads to daytime drowsiness, fatigue, indecision and significant impairment in learning and cognition,” he writes. “As a result, adults become moody, less efficient, and more likely to experience work-related injury; children are prone to be shy and may also become depressed, anxious or fearful.”
Consequently, presenteeism (decreased productivity at work due to illness) and school absenteeism (habitual absence) escalate.
Lack of Effectiveness of Currently Available Intranasal Sprays
While intranasal corticosteroids are the gold standard for symptom control, patients report problems with effectiveness of currently available options. Only 16 percent of respondents in the AIA survey indicated that intranasal corticosteroids provide relief for all their symptoms, and almost half (48 percent) said they fail to provide 24-hour symptom relief.
“Patients self-adjust their use of over-the-counter and prescription products, but find that currently available options do not always provide the 24-hour relief, and if they do, there are bothersome side effects,” explains Dr. Nathan. Consequently, the author concludes that there is a need for new nasal allergy medications that provide complete 24-hour symptom relief that is sustained over time.
About Allergies in America Survey
The Allergies in America survey is a landmark survey sponsored by ALTANA Pharma US, Inc. and is the largest survey ever conducted in a population of allergic rhinitis sufferers and healthcare practitioners. Analysis of the data from the 2,500 allergy sufferers and 400 physicians, nurse practitioners and physician assistants provides a window into to the behavioral and psychosocial effects of AR.
Asthma & Allergy Associates
http://www.texallergy.com/locations.htm
Add comment March 7, 2007
Flu Vaccine Recommended For People With Asthma
With flu season just around the corner, the American Academy of Allergy, Asthma & Immunology (AAAAI) is recommending that people with asthma and other chronic health conditions receive a flu vaccination as soon as possible.
Each year, millions of people in the United States get influenza. According to the Centers for Disease Control and Prevention (CDC), approximately 36,000 people per year in the United States die from influenza, and over 200,000 people have to be admitted to the hospital as a result of the flu.
Influenza is typically spread from person to person through coughing and sneezing via respiratory droplets. If someone with the flu coughs on you, there is a high chance you will develop flu symptoms within four days after the initial exposure to that person. Common flu symptoms include:
— Fever
— Muscle aches and tenderness
— Headache
— Fatigue
— Dry cough
— Sore throat
— Runny nose
“Symptoms of influenza can be especially severe for patients with respiratory diseases, such as asthma,” said Richard A. Nicklas, MD, FAAAAI, Chair of the AAAAI’s Asthma Diagnosis and Treatment Interest Section. “In severe cases, influenza can cause pneumonia, may require hospitalization and sometimes can be fatal.
” Research has found that the flu vaccine decreases the risk of asthma exacerbations in patients by as much as 22% to 41%. In addition, it can also protect against acute asthma exacerbations in children. Vaccinating all children with asthma could prevent up to 78% of asthma hospitalizations and emergency room visits during influenza seasons.
The flu season usually ranges from November through March, and peaks in December, January and February. It takes approximately two weeks to develop immunity from the vaccine so it is important to get vaccinated each fall in October or November, before the flu season begins.
Contrary to popular belief, you cannot get the flu from the flu vaccine. If you feel sick with flu-like symptoms after being vaccinated, you may have caught another respiratory virus or already had the flu virus in your system when you received the vaccine.
Discuss any questions that you may have regarding influenza or the flu vaccine with your physician. For more information, visit the AAAAI Web site, http://www.aaaai.org, the Centers for Disease Control and Prevention (CDC) Web site, http://www.cdc.gov/nip/flu, or call the CDC Immunization Hot Line at (800) 232-2522.
The AAAAI’s How the Allergist/Immunologist Can Help: Consultation and Referral Guidelines Citing the Evidence provide information to assist patients and health care professionals in determining when a patient may need consultation or ongoing specialty care by the allergist/immunologist. Patients should see an allergist/immunologist if they:
— Need to confirm the diagnosis of asthma
— Need education on asthma and guidance in techniques for self-management.
— Need for daily asthma reliever medications
— Are not using medications as prescribed, and this is limiting their ability to control their asthma
— Have potentially fatal asthma, meaning a prior severe, life threatening episode that included intubation
To find an allergist/immunologist in your area, call the AAAAI Physician Referral and Information Line at (800) 822-2762 or visit the AAAAI Web site at http://www.aaaai.org/physref/.
The AAAAI is the largest professional medical specialty organization in the United States representing allergists, asthma specialists, clinical immunologists, allied health professionals and others with a special interest in the research and treatment of allergic disease. Established in 1943, the AAAAI has more than 6,000 members in the United States, Canada and 60 other countries. The AAAAI serves as an advocate to the public by providing educational information through its Web site at http://www.aaaai.org.
American Academy of Allergy, Asthma & Immunology (AAAAI)
http://www.aaaai.org
Add comment March 7, 2007
New England Journal OF MEDICINE Reports Positive Results From Dynavax’ Ragweed Allergy Therapy Trial
The NEW ENGLAND JOURNAL OF MEDICINE (Vol. 355, October 5, 2006, No.14), today reported that a new approach to allergy therapy not only reduced the acute allergic responses of individuals with ragweed allergies but also sustained that effect for over 12 months. The novel treatment, called “AIC” in the paper, is a TLR9 agonist linked to ragweed allergen, developed by Dynavax Technologies Corporation (Nasdaq: DVAX).
Dr. Peter Creticos, principal investigator and lead author of the paper, entitled, “Immunotherapy with a Ragweed-Toll-like Receptor 9 Agonist Vaccine for Allergic Rhinitis,” said that the pilot study “appears to offer a means of achieving long-term clinical efficacy in ragweed allergic rhinitis as the clinical effects suggest the induction of long-lasting disease modification. Furthermore, the demonstrated therapeutic properties and safety pave the way for a therapeutic intervention that is qualitatively superior to standard immunotherapy.” Dr. Creticos is Associate Professor of Medicine and Clinical Director of the Division of Clinical Immunology of The Johns Hopkins University School of Medicine. He serves as Medical Director of the Johns Hopkins Asthma and Allergy Center in Baltimore, Maryland.
In the paper, Dr. Creticos pointed to statistically significant efficacy results including peak Nasal Symptom Complex Score (NSCS) reductions in AIC-treated patients of 55% (p=0.03) in 2001 which persisted through the 2002 ragweed season (53% reduction in NSCS, p=0.02) with no additional therapy. Additionally, the AIC-treated group used no relief medication at all during the second season, while placebo patients used antihistamines for 8 days (average) and decongestants for 4 days (average) of the two-week peak season. The intervention also generated clinically significant quality of life improvements for patients. Dr. Creticos added that the intervention was safely tolerated as no treatment-associated serious adverse reactions were reported, nor did any lab tests show abnormalities in the patients tested.
With funding from the National Institute of Allergy and Infectious Diseases and the Immune Tolerance Network, and the study drug provided by Dynavax, Dr. Creticos conducted a blinded, randomized, placebo-controlled, clinical trial in 25 ragweed allergic patients beginning in May 2001 and concluding in October, 2002. Patients were treated with either the drug or placebo, using a 6-injection regimen, prior to the first ragweed season, and were followed for two years. Dynavax supplied the study drug, now known as TOLAMBA(TM), and contributed to trial design, but did not participate in data accrual, analysis, or funding of the trial. TOLAMBA, consisting of a TLR9 agonist linked to a specific ragweed allergen, is currently being evaluated in late-stage clinical trials for the treatment of allergic rhinitis.
DYNAVAX Clinical Trials Update
In the paper, Dr. Creticos recommends additional large-scale studies, which are now underway at Dynavax. Since the reported study’s initiation in 2001, Dynavax has generated a substantial amount of data in 14 clinical trials in the U.S., France, and Canada. More than 7,000 TOLAMBA injections have been administered to over 1,100 patients. In these trials, TOLAMBA was shown to be safe and well tolerated, to provide measurable improvements in allergy symptoms, and to reduce medication use.
TOLAMBA consists of 1018 ISS, a TLR9 agonist, linked to the purified major allergen of ragweed, called Amb a 1. The linking of ISS to Amb a 1 ensures that both ISS and ragweed allergen are presented simultaneously to the same immune cells, producing a highly specific and potent effect suppressing the Th2 cells responsible for inflammation associated with ragweed allergy. Moreover, this treatment reprograms the immune response away from the Th2 response and toward a Th1 memory response so that, upon subsequent natural exposure to the ragweed allergen, long-term protection is achieved.
Other Clinical Results; Trial Background
A Dynavax-funded, 30-center, placebo-controlled study in 738 ragweed allergic subjects, aged 18 to 55 years, is expected to produce interim data at one-year in the first quarter of 2007. The study known as “DARTT” (Dynavax Allergic Rhinitis TOLAMBA Trial) randomized subjects into three arms: the same dosing regimen that was used in the completed Phase 2/3 trial; a higher total dose regimen; and placebo. Subjects received six doses over six weeks prior to the start of the 2006 ragweed season. Ragweed symptoms were followed over the 2006 ragweed season and will also be followed through the 2007 season. The primary endpoint is reduction in total nasal symptom scores (TNSS) during the second (2007) peak ragweed season. Dynavax anticipates that data from the DARTT interim analysis, if positive, combined with the safety and efficacy data from the recently completed two-year Phase 2/3 trial, and from an ongoing trial in ragweed allergic children, could provide sufficient patient data for determining the potential timeline to registration for the intervention.
Additionally, Dynavax is evaluating TOLAMBA in a three-year, 19-center, pediatric trial with over 300 patients, ages six to 15 years. The primary endpoint of the study is reduction in TNSS during the 2006 peak ragweed season; a key secondary endpoint is the prevention of progression to asthma. The study was initiated in early 2005. Primary endpoint data for the study is expected in early 2007.
In January 2006, Dynavax announced that results from a two-year Phase 2/3 clinical trial of TOLAMBA showed that patients treated with TOLAMBA experienced a statistically significant 28.5% reduction in total nasal symptom scores (TNSS) compared to placebo-treated patients in the second year of the trial (p=0.024). Results also showed significant clinical benefit relative to secondary endpoints, including composite hay fever symptoms and ocular effects, and a significant reduction in antihistamine use (p=0.01). These results were achieved after a single short course of therapy prior to the first ragweed season (2004), and demonstrated that a booster dose prior to the second season (2005) was not required to achieve clinical benefit. The safety profile of TOLAMBA was favorable; systemic side effects were indistinguishable from placebo and local injection site tenderness was minor and transient.
TOLAMBA represents the foundation of a comprehensive allergy franchise for Dynavax, and has the potential to be a novel entrant in the multibillion- dollar global allergy market. In the U.S. alone, approximately 40 million people suffer from allergic rhinitis. Ragweed is the single most common seasonal allergen, affecting up to 75% of those with allergic rhinitis, or 30 million Americans. Current therapeutic options are mainly limited to symptomatic therapies and conventional allergy immunotherapy, which generally requires 60-90 shots over three to five years and represents a significant treatment burden for allergy sufferers. Dynavax believes that TOLAMBA has the potential to become the first of several new and important disease-modifying therapeutic options for patients and physicians.
About Dynavax
Dynavax Technologies Corporation discovers, develops, and intends to commercialize innovative TLR9 agonist-based products to treat and prevent allergies, infectious diseases, cancer, and chronic inflammatory diseases using versatile, proprietary approaches that alter immune system responses in highly specific ways. Our clinical development programs are based on immunostimulatory sequences, or ISS, which are short DNA sequences that enhance the ability of the immune system to fight disease and control chronic inflammation. Dynavax’s pipeline includes: TOLAMBA, a ragweed allergy therapeutic, for which a major safety and efficacy trial (DARTT) is currently underway, and that is in a supportive clinical trial in ragweed allergic children; HEPLISAV(TM), a hepatitis B vaccine in Phase 3; and a therapy for non-Hodgkin’s lymphoma in Phase 2. Its preclinical asthma and COPD programs are partnered with AstraZeneca. Funding for the company’s other preclinical programs in cancer, hepatitis B and hepatitis C therapies, and for an influenza vaccine have been provided by Symphony Dynamo and NIH, and represent future partnering opportunities. Preliminary data from the study published today in the NEJM were previously reported at the AAAAI 2003 annual meeting. For more information, please visit http://www.dynavax.com.
This press release contains forward-looking statements that are subject to a number of risks and uncertainties, including statements about our clinical development plans and timelines, business plans, future operating results, intellectual property position and potential sources of funds. Actual results may differ materially from those set forth in this presentation due to the risks and uncertainties inherent in our business, including difficulties or delays in development, achieving the objectives of our collaborative and licensing agreements and obtaining regulatory approval for our products; the scope and validity of patent protection for our products; competition from other companies; our ability to obtain additional financing to support our operations; and other risks detailed in the “Risk Factors” section of our Annual Report on Form 10-K and Quarterly Report on Form 10-Q. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
Dynavax Technologies Corporation
http://www.dynavax.com
Add comment March 7, 2007
Ragweed Allergy Vaccine Effective For At Least One Year
A new vaccine trial has been shown to protect people from ragweed pollen allergy for at least one year, according to an article in the New England Journal of Medicine. This experimental treatment requires just six injections, once a week. Current treatments require taking several medications each day throughout the ragweed season.
Allergic reactions to plant pollens are commonly known as Hay Fever
Trial researchers said further studies have to be carried out on a larger group of volunteers.
Study author, Dr. Peter Socrates Creticos, Johns Hopkins Asthma and Allergy Center, Baltimore, USA, and team, expanded on studies that had been carried out at the University of California, San Diego, which discovered that a bacterium DNA sequence shuts down Th2 (T-helper) cell activity – an inflammatory immune system response. Th2 is commonly found to be a major factor in human allergic responses.
To create a new vaccine the team attached the DNA sequence that halts Th2 response to a portion of the ragweed pollen. Th2 cells often overreact to ragweed pollen – the new vaccine stops the Th2 from overreacting.
The Th2 cells of people who are allergic to ragweed make the body produce igE, which causes the watery eyes and sneezing. The vaccine stops the Th2 cells from sending signals which make the body produce IgE when exposed to ragweed.
The problem with current allergy medications is that they are not well targeted. Current medications have side effects because they undermine the body’s immune system. This new vaccine is finely targeted – there are fewer side effects, say the researchers.
Twenty-five volunteers, aged 23-60, took part in this pilot trial,. All of them suffered from ragweed allergy. 14 were given six injections with the new vaccine, one each week consecutively. The other 11 were given a placebo injection, once a week for six weeks. Both groups started treatment before the ragweed season began.
Allergy symptoms during the ragweed season were 60% lower for the 14 who received the new vaccine, compared to the placebo group. Allergy relief continued during the next season, a year later (no additional treatment had been given).
Ragweed Allergy – Some Facts
The ragweed pollen season runs from August to November. Most areas in the USA see a peak in ragweed pollen levels in mid-September. Pollen counts tend to peak between 5am to 10am.
If you suffer from ragweed pollen allergy
— Try to stay indoors between 5am to 10am – unless there has been some heavy rain
— Try to keep the windows of your home and car closed
— Avoid using fans
— If your allergy is severe, remember that people can bring the pollen into the home on their clothing
— Pets can bring the pollen in
— Avoid drying your clothes by hanging them outside
Symptoms
— eye irritation
— inflamed, itchy nose and throat
— puffy eyes
— runny nose
— sneezing
— stuffy nose
If your allergy is more severe, symptoms may also include the following:
— asthma attacks
— chronic sinusitis
— headaches
— impaired sleep
Immunotherapy with a Ragweed-Toll-Like Receptor 9 Agonist Vaccine for Allergic Rhinitis
Peter S. Creticos, M.D., John T. Schroeder, Ph.D., Robert G. Hamilton, Ph.D., Susan L. Balcer-Whaley, M.P.H., Arouna P. Khattignavong, M.D., Robert Lindblad, M.D., Henry Li, M.D., Ph.D., Robert Coffman, Ph.D., Vicki Seyfert, Ph.D., Joseph J. Eiden, M.D., Ph.D., David Broide, M.B., Ch.B., and the Immune Tolerance Network Group
NEJM Volume 355:1445-1455 – October 5, 2006 – Number 14
Click here to see abstract online
Written by: Christian Nordqvist
Editor: Medical News Today
Add comment March 7, 2007
Allergy Sufferers Offered Longer Relief With Fewer Shots Using Experimental Ragweed Therapy
Americans accustomed to the seasonal misery of sneezing, runny noses and itchy, watery eyes caused by ragweed pollen might one day benefit from an experimental allergy treatment that not only requires fewer injections than standard immunotherapy, but leads to a marked reduction in symptoms that persists for at least a year after therapy has stopped, according to a new study in the October 5 issue of i The New England Journal of Medicine (NEJM). The research was sponsored by the Immune Tolerance Network, which is funded by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), both components of the National Institutes of Health (NIH), and the Juvenile Diabetes Research Foundation International.
“As many as 40 million Americans suffer from seasonal allergies caused by airborne pollens produced by grasses, trees and weeds,” says NIH Director Elias A. Zerhouni, M.D. “Finding new therapies for allergy sufferers is certainly an important research goal.”
“This innovative research holds great promise for helping people with allergies,” says NIAID Director Anthony S. Fauci, M.D. “A short course of immunotherapy that reduces allergic symptoms over an extended period of time will significantly improve the quality of life for many people.”
Ragweed is one of the most common pollens in the United States and is prevalent in the Northeast, Midwest and the South. In Baltimore, where the NEJM study was conducted, the ragweed pollen season lasts from mid-August to October.
Physicians treat people suffering from mild and moderate ragweed allergies with antihistamines or nasal corticosteroids. However, when people with allergies do not respond to these treatments or experience severe symptoms, the next therapeutic option is a course of subcutaneous injections of the allergen, which is called allergen immunotherapy. Although this standard immunotherapy is often effective, it has two major drawbacks. First, it can cause systemic allergic reactions, such as anaphylaxis, a hypersensitivity reaction that can lead to severe and sometimes life-threatening physical symptoms. Second, to provide long-lasting relief, standard immunotherapy may require frequent injections over a 3- to 5-year period. The large number of injections over such an extended period of time often results in many people not completing the treatment.
In the study detailed in NEJM, lead investigator Peter Creticos, M.D., medical director of the Johns Hopkins Asthma and Allergy Center in Baltimore, and his research team found that an investigational therapy based on the major ragweed allergen, Amb a 1, coupled to a unique short, synthetic sequence of DNA that stimulates the immune system, reduced allergy symptoms in adults for at least one year when given just once a week over a 6-week period. The therapeutic agent was provided by Dynavax Technologies Corp., based in Berkeley, CA.
“For almost 100 years, we’ve been using the tedious process of giving allergy sufferers one to two shots a week for up to 4 to 5 years to ensure its success,” Dr. Creticos says. “This study is an important immunotherapy advance in that we’ve shown you can induce long-lasting relief from allergic rhinitis with just a few weeks of injections.”
The study initially involved 25 adult volunteers, ages 23 to 60, with a history of seasonal allergic rhinitis, positive skin test reactions to ragweed pollen, and an immediate reaction when nasally challenged with ragweed. Prior to the start of the 2001 fall ragweed season, the study participants received six injections, each a week apart, of either the investigational therapy in increasingly higher doses or a placebo. They received no other injections throughout the course of the study. Fourteen volunteers received the study drug; 11 were given the placebo. The therapy was well-tolerated and caused only limited local reactions, which required neither medication nor change in treatment dose. No clinically significant, therapy-related adverse events occurred.
Throughout the 2001 and 2002 ragweed seasons, the volunteers were monitored for allergy-related symptoms, including the number of sneezes and the degree of post-nasal drip, allergy medication use and quality-of-life scores. Compared with the placebo recipients, the group that received the therapy experienced dramatically better outcomes that continued throughout the 2002 ragweed season even though therapy ended one year earlier.
Clearly, the regimen of only six injections showed therapeutic promise when compared with the current therapy, the study authors note. However, because the results are based on a small number of volunteers and the long-term safety of the therapy is unknown, they say additional clinical trials with longer-term follow-up to adequately assess the therapy’s safety and effectiveness are necessary.
How the experimental therapy relieves ragweed allergy symptoms is not fully understood at this time. When exposed to ragweed pollen, people who are allergic to ragweed experience an increase in IgE (immunoglobulin) antibodies; immunotherapy blocks this increase in IgE. Researchers believe the experimental therapy tempers the release of immune regulatory proteins called cytokines, which blocks increases in the level of IgE antibodies.
“Using ragweed as a model allergen system with a predictable seasonal pattern of symptoms and pollen counts, it is possible to correlate pollen levels with symptoms and measure treatment effects on symptoms. This enables us to better understand immune response to allergens and serves as an approach to similar therapies to manage other allergic reactions for which there are currently no treatments, such as food allergies,” says Marshall Plaut, M.D., chief of the Allergic Mechanisms Section of NIAID’s Division of Allergy, Immunology and Transplantation.
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NIAID is a component of the National Institutes of Health. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on basic immunology, transplantation and immune-related disorders, including autoimmune diseases, asthma and allergies.
The National Institutes of Health (NIH)–The Nation’s Medical Research Agency–includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov/.
Reference: PS Creticos et al. Immunotherapy with a ragweed-TLR9 agonist vaccine for allergic rhinitis. The New England Journal of Medicine DOI: 10.1056/NEJMoa052196 (2006).
News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov/.
Contact: Kathy Stover
NIH/National Institute of Allergy and Infectious Diseases
Add comment March 5, 2007
EU Health Research Must Prioritise Allergies
European public health experts are concerned because “allergic diseases” in all their different aspects – from hay fever to fatal attacks of asthma or reactions to peanuts – are not included in the health priorities of the EU research programme. While allergies are mentioned among the food research priorities, the absence of wider allergy problem as a top concern in health research agenda threatens to comprise overall progress in the understanding of this complex condition.
Paul van Cauwenberge, Coordinator of GAІLEN (Global Allergy and Asthma European Network), says that if the European Union does not make it a top concern in health research, researchers and practitioners may fail to contain the allergy epidemic. (1)
“GAІLEN has helped to demonstrate the magnitude of this public health problem and begun to find the solutions,” says Prof. van Cauwenberge of the University of Ghent, Belgium. “But if allergic diseases are not included as a health priority in the next EU framework programme FP7 (2), we are much less likely to build the overall understanding we need to help control this epidemic through effective prevention and treatment.” (2)
While allergy experts welcomed the fact that allergy was considered under the food safety programme in the FP6, they point out that only 8% of allergies in Europe are related to food. Allergic diseases represent a “global” problem in the sense that it has multiple presentations and causes, both genetic and environmental. All the different aspects of the condition and its triggers must be addressed to gain a comprehensive understanding of allergic diseases as a whole.
Prof. van Cauwenberge believes that politicians and different authorities would want to be alerted to the absence of the overall allergy and asthma problem within the research agenda. “If Europe does not continue to make major investments into integrating and co-ordinating research for an overall vision, we are unlikely to get to grips with why the rapid increase in prevalence is occurring, nor to be able to identify and introduce into clinical practice the best ways to prevent and manage the problem,” he says.
Allergic diseases are taking lives daily and creating huge financial costs. According to the World Health Organization, asthma kills someone in Europe every hour. (3) One child in three is allergic today and by 2015, half of the European population may be suffering from one or more allergic condition. (4)
Estimates have put the financial costs of allergic diseases in Europe at up to 100 billion Euros per year. (4) The personal costs fall particularly heavily on families. Parental fears of a serious attack create anxiety, and even with mild allergies family activities may be limited. Children miss days at school and abstain from sport and other recreational activities. Breathing problems and skin rashes can also harm the self-image of young children, adults and especially teenagers. (5)
The GAІLEN network has successfully brought together 26 “centres of excellence” in allergies spread through different European countries with the aim to advance the diagnosis, prevention and treatment of allergic diseases. European researchers and doctors involved are now using standardised skin-prick allergy tests so that Europe-wide comparative analysis can take place. In the last few months, a huge European database of comparable longitudinal epidemiological studies, known as birth cohorts, has been finalised so that significantly more reliable analysis can now be made of the multiple genetic and environmental factors causing allergies.
Working with partner organizations representing allergy specialists and patients’ groups (1), GAІLEN is developing evidence-based guidelines for health professionals and the patients to help them preventing and managing the disease. GAІLEN urges policy makers to support the European Parliament proposal to include allergic diseases in the health priorities of the 7th research framework programme.
1. GAІLEN – the Global Allergy and Asthma European Network is a “Network of Excellence” funded by the European Union 6th Research Framework Programme. It consists of 26 research centres spread throughout Europe, as well as the European Academy of Allergology and Clinical Immunology (EAACI) and the European Federation of Allergy and Airways Diseases Patients Associations (EFA). More than 30 collaborating centres have joined the network since its launch in 2004.
2. The European Union’s next research programme, known as the Seventh Framework Programme Seven (FP7), begins next year and will run for seven years until 2013.
3. World Health Report 2003, “Shaping the Future”. World Health Organization.
4. “Allergy: An epidemic that must be stopped”, Position Paper, European Academy of Allergology and Clinical Immunology (EAACI). http://www.efanet.org/activities/eu_policy.html
5. “EU 7th Framework Programme for Research”, Position Paper, European Federation of Allergy and Airways Diseases Patients Associations (EFA). http://www.efanet.org/activities/eu_policy.html
GAІLEN – the Global Allergy and Asthma European Network
Add comment March 5, 2007
FDA Approves Allegra(R) (fexofenadine Hydrochloride) Oral Suspension For Treatment Of Seasonal Allergy Symptoms And Chronic Idiopathic Urticaria
Sanofi-aventis U.S. (EURONEXT: SAN and NYSE: SNY) announced today that the U.S. Food and Drug Administration (FDA) has approved Allegra(R) (fexofenadine hydrochloride) Oral Suspension for the twice-daily treatment of symptoms associated with seasonal allergies in pediatric patients, 2 to 11 years of age, and for the treatment of chronic idiopathic urticaria in children 6 months to 11 years of age. This approval makes available a safe and effective seasonal allergy treatment option that is non-impairing to pediatric populations as young as 2 years old.
“Until now, parents had few seasonal antihistamine treatment options that were not associated with cognitively impairing adverse side effects,” says Eli Meltzer, M.D., of the Allergy and Asthma Medical Group and Research Center in San Diego. “However, with Allegra Oral Suspension, which does not cause sedation at any dose and is well-established for its antihistamine activity, a medication is now available in a good tasting, easy-to-swallow formulation that can help reduce the seasonal allergy symptoms of children.”
Seasonal allergic rhinitis is a common chronic condition in children. Symptoms of seasonal allergies include nasal drainage, sneezing, watery eyes and itchy nose, eyes and throat. Studies indicate that seasonal allergy inflammation as well as the impairing side effects of older antihistamines can be disruptive to a child and may affect cognitive skills and function.
Allegra Oral Suspension has also been approved for the treatment of chronic idiopathic urticaria (CIU) in twice-daily 30 mg doses for pediatric patients 2 to 11 years of age and twice-daily 15 mg doses for pediatric patients 6 months to 2 years of age. CIU is a rare and bothersome condition characterized by hives lasting more than 6 weeks from an unknown cause. Its symptoms are caused by a reaction to an unknown trigger in the upper layers of the skin. The condition itself may cause severe itching, but is made worse by scratching.
Allegra Oral Suspension will have a berry flavor* and is expected to be available to consumers in time for the 2007 spring allergy season.
Artificial raspberry-cream flavoring
Important Safety Information
Side effects in children 6 months to 5 years old were similar to placebo. Side effects varied by age. The most commonly reported side effects were: vomiting, pyrexia, cough, otitis media and diarrhea.
Please see full prescribing information for Allegra Oral Suspension at http://products.sanofi-aventis.us/allegra_oral/allegra.pdf.
About sanofi-aventis
Sanofi-aventis is the world’s third largest pharmaceutical company, ranking number one in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine, and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY)
Forward Looking Statements
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sanofi-aventis
http://www.sanofi-aventis.com
Add comment March 5, 2007
First Asthma Census Highlights Lack Of Control Of Condition, UK
An Asthma UK census has revealed that only 4% of those people questioned have their asthma under control.
The shocking results follow Asthma UK’s first ever asthma control census which was launched on World Asthma Day in May this year. It aimed to raise awareness amongst the 4.1 million adults with asthma in the UK that they may be putting up with symptoms that impact unnecessarily on their quality of life.
The Asthma Control Test, a 60-second, five-point questionnaire was completed online by over 16,000 people. The test which gives a score out of 25, helps to identify the level of asthma control.
Results also highlighted that more than a third of people experienced shortness of breath on a daily basis and for 1 in 4, using their reliever inhaler more than three times a day was a regular occurrence. This is a clear indication that their asthma is not under control as asthma management guidelines state that a person’s asthma is not well managed if they use their reliever inhaler more than three times a week.
The census further revealed that as a person got older, their asthma worsened. For those that completed the test, scores decreased for the older age groups and showed that for many, being woken at night or earlier in the morning with asthma symptoms such as coughing or wheezing, was a regular occurrence.
Professor Martyn Partridge, Chief Medical Advisor at Asthma UK said: ‘The results of this census highlight that a high proportion of people in the UK are putting up with unnecessary symptoms on a daily basis. They could be getting a better night’s sleep, going about their everyday life without thinking about their asthma and using their reliever inhaler far less. With simple and safe medication, their asthma could be under control. I would advise making an appointment to see your GP or asthma nurse so that they can have an asthma review. The ultimate aim should be that you control your asthma, and not that it controls you.’
1. The Asthma Control Test is suitable for people with asthma aged 12 and over.
2. ©2002, by QualityMetric Incorporated. Asthma Control Test is a trademark of QualityMetric Incorporated. “US English version modified for use in UK”
3. Asthma UK is the charity dedicated to improving the health and well being of the 5.2 million people in the UK whose lives are affected by asthma. For up-to-date news on asthma, information and publications, visit the Asthma UK website http://www.asthma.org.uk.
4. For independent and confidential advice on asthma, call the Asthma UK Adviceline, which is staffed by asthma nurse specialists. It is open weekdays from 9am to 5pm on 08457 01 02 03. Or email an asthma nurse at http://www.asthma.org.uk/adviceline.
Add comment March 5, 2007
Allergists Explore Rising Prevalence And Unmet Needs Attributed To Allergic Rhinitis
As the prevalence of allergic rhinitis appears to be rising, there are increasing concerns about its impact on health, sleep, work and school performance, as well as unmet patient needs regarding its treatment according to experts presenting new data at the Annual Meeting of the American College of Allergy, Asthma and Immunology (ACAAI).
“There is epidemiological evidence that the prevalence of allergic rhinitis is rising worldwide. Reports indicate that it has increased 100 percent in each of the last three decades in developed countries,” said Eli O. Meltzer, M.D., co-director, Allergy & Asthma Medical Group & Research Center, and clinical professor of pediatrics at the University of California in San Diego.
“With allergic disorders estimated to affect some 1.4 billion people globally, there appears to be a worldwide epidemic of allergic diseases. Studies suggest this is likely a consequence of our changing environment, reduced infections and genetic susceptibilities.”
According to Dr. Meltzer, the true prevalence of allergic rhinitis is unknown. Published prevalence rates differ because:
— It is largely undiagnosed
— There are differences in definitions of the condition
— There are differences in sampling frame and data collections methods
— The data are not collected by the federal government.
Current estimates indicate that more than 50 million people in the United States suffer from allergic rhinitis. It is the most prevalent chronic condition in patients under age 18. In one study, 42 percent of children had physician-diagnosed allergic rhinitis by 6 years of age.
Substantial Burden
Two landmark U.S. surveys – the Burden of Rhinitis Survey 2004 and the Allergies in America Survey 2006 – document the high prevalence and substantial burden of allergic rhinitis. Both surveys indicate a strong relationship between allergic rhinitis and co-morbidities including depression, migraine and asthma.
According to Michael S. Blaiss, M.D., clinical professor of pediatrics and medicine at the University of Tennessee Health Science Center in Memphis, Tenn., the scope and impact of allergic rhinitis has reached epidemic proportions and is estimated to account for 100 million days of lost work annually, 28 million days of lost productivity and 1.5 million missed school days per year. Allergic rhinitis is responsible for 16.7 million physician office visits per year and results in 5.9 billion dollars annually in direct expenditures.
“Many patients with allergic rhinitis suffer from symptoms that cause them to feel tired, miserable and irritable during allergy season,” Dr. Blaiss said. “Lack of treatment, under-treatment, or non-adherence to treatment in allergic rhinitis may increase direct and indirect costs. This reinforces the need for patient education and for physicians to implement existing evidence-based guidelines for prevention and treatment.”
Allergic rhinitis symptoms profoundly affect the quality of life as well as work productivity according to Myron J. Zitt, M.D., clinical associate professor of medicine, State University of New York, Stony Brook, N.Y. “Adults may have mood swings and be less efficient at work or at home. They often have a poor quality of sleep, may suffer from obstructive sleep apnea and thereby experience daytime fatigue.” He noted a correlation between high pollen counts and low work productivity.
“Children with allergic rhinitis often experience increased shyness, anxiety and fatigue. Nasal congestion and other symptoms can cause significant impairment in learning and cognition,” he said.
“Another area of concern is the trivialization of allergic rhinitis. It is an important illness, but it is underappreciated, under-diagnosed and under-treated. Polls show that only 19 percent of people taking medications for allergic rhinitis are being seen by a specialist, who are the best qualified to treat the disease,” Dr. Zitt said.
In a Harris Interactive Survey of 4,000 patients who experience congestion, 93 percent of patients surveyed awaken feeling congested and 87 percent awaken feeling tired. Lack of relief of congestion affects their ability to concentrate (54 percent), performance of physical exercise and sports (63 percent) and time spent outdoors (73 percent).
Typical physical findings reported by Bobby Q. Lanier, M.D., clinical professor of pediatrics at the University North Texas Health Science Center in Fort Worth, include: the “Allergic Salute” wiping of the nose; “Allergic Shiners” referring to dark circles under the eyes; “Allergic Crease” around the nose; “Dennie’s Lines” under the eyes; mouth breathing; red, itchy eyes and eye tearing.
“Comorbidities of allergic rhinitis are significant. Allergic rhinitis is present in 58 percent of asthma patients, and the treatment of allergic rhinitis reduces the incidence and severity of asthma. It also contributes between 40 percent to 80 percent of chronic rhinosinusitis. Nasal polyps reoccur in 36 percent of allergic individuals versus 18 percent in non-allergic individuals,” said Dr. Lanier.
Treatment of Allergic Rhinitis
Recent surveys show that 37 percent of patients are not satisfied with their current allergy treatment, and patients may take up to 2 to 4 medications at a time for relief of allergy symptoms noted Dr. Lanier.
“Patients are not as well informed as they should be about their allergy medications,” he said. Of those surveyed, 42 percent were confused by choices of medication, and 59 percent wished they knew more about the drugs they take.
“Healthcare providers overestimate patient satisfaction with therapy. Patient dissatisfaction often results in frequent medication changes or noncompliance. Lack of insurance coverage for prescribed medications influences patients’ willingness to try new medications,” Dr. Lanier said.
Current treatment options for allergic rhinitis are environmental control measures, medications, subcutaneous specific immunotherapy and allergen avoidance. Medications include oral antihistamines (sedating and non-sedating or low-sedating), intranasal antihistamines, intranasal corticosteroids or intranasal cromolyn sodium.
“New and emerging solutions for the treatment of allergic rhinitis are on the horizon,” said William E. Berger, M.D., M.B.A., clinical professor, Department of Pediatrics, Division of Allergy and Immunology at the University of California in Irvine. “These therapies include sublingual immunotherapy (SLIT), anti-IgE therapy, new topical nasal antihistamines (olopatadine) and new topical nasal corticosteroids (ciclesonide).”
In Europe, SLIT is widely used for monosensitized patients with mild allergic disease. There is no product approved by the FDA, although clinical trials of SLIT are underway in the United States.
Anti-IgE therapy, a recombinant humanized monoclonal antibody (rhuMab) to IgE, is currently approved for allergic asthma and may have application for patients with severe allergic rhinitis.
According to Dr. Berger, the emerging allergic rhinitis treatments focus on meeting both patient and provider needs for rapid onset, long-lasting and convenient dosing. They will be safer and more cost-effective, and improve patient adherence. Physician’s needs will be met for the introduction of newer, enhanced treatment choices that improve patient quality of life and immune tolerance. The newer therapies will also enhance the effective treatment of co-morbidities of allergic rhinitis.
Non-allergic Rhinitis
Non-allergic rhinitis is characterized by recurrent or chronic symptoms similar to those of allergic rhinitis, but the disorder is not caused by allergy. Examples of rhinitis are infectious rhinitis (the common cold), vasomotor rhinitis, non-allergic rhinitis with eosinophilia syndrome (NARES), hormonal rhinitis, certain types of occupational rhinitis, and gustatory and drug-induced rhinitis.
Irritants that can trigger vasomotor rhinitis include cigarette smoke, strong odors and fumes, including perfume, hair spray, other cosmetics, laundry detergents, cleaning solutions, pool chlorine, car exhaust and other air pollution. Other irritants are spices used in cooking, alcoholic beverages (particularly beer and wine), aspirin and certain medications.
Patient information on allergic diseases is available by calling the ACAAI toll free number at (800) 842-7777 or visiting its Web site at http://www.acaai.org/.
About ACAAI
The American College of Allergy, Asthma and Immunology (ACAAI) is a professional medical organization headquartered in Arlington Heights, Ill., that promotes excellence in the practice of the subspecialty of allergy and immunology. The College, comprising more than 5,000 allergists-immunologists and related health care professionals, fosters a culture of collaboration and congeniality in which its members work together and with others toward the common goals of patient care, education, advocacy and research.
American College of Allergy
85 W. Algonquin Rd., Ste 550
Arlington Heights, IL 60005
United States
http://www.acaai.org/
Add comment March 5, 2007
Research Findings In Allergy-Immunology Unveiled
Investigators are presenting more than 380 abstracts on preliminary findings in the diagnosis and treatment of allergic diseases at the ACAAI Annual Meeting in Philadelphia, Nov. 9-15. Following are highlights of some key investigations on allergic rhinitis and ocular allergies.
ALLERGIC RHINITIS
“Patient Perspectives on the Symptoms of Allergic Rhinitis and the Effect of Allergic Rhinitis on Daily Living.” (Abstract #29: Nov. 12 at 2:00 p.m.) – Michael S. Blaiss, M.D., Memphis, et al – Allergic rhinitis (AR) is a chronic inflammatory disease of the upper airways affecting 10 percent to 25 percent of the world’s population. Of the 2,500 adults with AR who were surveyed by telephone interview, 40 percent reported that congestion was the most frequent symptom and was extremely bothersome. Post-nasal drip (28 percent), runny nose (26 percent) and red, itching eyes (23 percent) were also reported by patients as extremely bothersome symptoms. Approximately one third of patients with nasal allergies also suffered from asthma.
“Yuletide Allergy Symptoms.” (Abstract #P200: Nov. 11-12, Noon – 1:00 p.m.) – Michael Alexander, M.D., Niagara Falls, Canada, et al – This investigation using completed questionnaires from four atopic subjects, and testing with airborne sampling and tree trunk tape lifts, demonstrates that patients with seasonal allergic rhinitis can experience symptoms caused by a Christmas tree in their homes. Christmas trees are a significant source of allergens, particularly mold. Airborne sampling revealed increased mold spores with the introduction of the tree, and a secondary burst of mold spores with the removal of the tree.
“3-Year Treatment of Children with Triamcinolone Acetonide Aqueous for Allergic Rhinitis Does Not Affect Statural Growth.” (Abstract #P217: Nov. 11-12, Noon – 1:00 p.m.) – David Skoner, M.D., Pittsburgh, Pa., et al – Guidelines recommend intranasal corticosteroids for patients with allergic rhinitis (AR) but concerns remain as to possible adverse effects on growth. In an ongoing investigation, the 3-year results show that no statistical difference (at the 0.0005 level) was detected in the height of 19 children (aged 6.1 – 14.0 years at entry) receiving triamcinolone acetonide aqueous treatment for allergic rhinitis.
“Impact of Congestion Associated with Allergic Rhinitis on Sleep, Daytime Somnolence and Fatigue, and Work and School Productivity.” (Abstract #P220: Nov. 11-12, Noon – 1:00 p.m.) – Donald.E. Stull, M.D., Bethesda, Md., et al – Investigators report that symptoms associated with allergic rhinitis (AR) include impaired sleep resulting in day-time somnolence and fatigue, reduced productivity at work or school, and increased health care costs. This study explored the impact of congestion relative to the broader collection of AR symptoms. Authors conclude that nasal congestion alone has a significant, negative impact on patients’ lives, accounting for most of the negative impact of AR symptoms on sleep adequacy. Congestion increases the likelihood of sleep problems, symptoms during sleep time, sleep disturbance, shortness of breath or headache, snoring, daytime somnolence and fatigue.
“Global Climatic Change and its Impact on Oak Pollen Season in the Midwestern US.” (Abstract #P278: Nov. 11-12, Noon – 1:00 p.m.) – Gregory G. Pendell, M.D., et al, Kansas City, Mo. – Authors note that the last decades of the 20th century have been reported to be warmer than any comparable period in the past 1,000 years. This investigation, using a Burkhard spore trap operating from February to November during 1997 through 2006 in the urban core of Kansas City, shows that oak pollen season appears to begin a half day earlier each year. Authors conclude that the trend to an earlier oak pollen season in the Midwest should reach statistical significance in the next five years.
NON-ALLERGIC CONJUNCTIVITIS
“Non-allergic, Non-infectious Conjunctivitis. Potential for Urban Eye Syndrome?” (Abstract #P201: Nov. 11-12, Noon – 1:00 p.m.) – Bobby Lanier, M.D., Fort Worth, Texas – Investigators determined by phone survey that almost 25 of 100 patients with non-allergic rhinitis also suffer from ocular symptoms. Itching was the most common symptom (91 percent) following by burning (82 percent), redness (73 percent) and dry eye (55 percent). Seasonality was the most common trigger (77 percent) followed closely by environmental (68 percent), chemicals (50 percent), pollution (36 percent) and animals (9 percent).
IMMUNOTHERAPY
“Safe and Effective Rapid Desensitization: A Cumulative Experience of 1,540 Patients.” (Abstract #20: Nov. 12 at 1:45 p.m.) – William Smits, M.D., Fort Wayne, Ind., et al – Conventional immunotherapy is effective in the treatment of allergic rhinitis, allergic asthma and chronic rhinosinusitus. Authors note that rapid desensitization (or rush immunotherapy) offers the advantages of rapid response, improved compliance and cost effectiveness, but safety continues to be a primary concern for this procedure. Investigators confirm in this study of 1,540 patients that maintenance immunotherapy can be reached quickly, safely and effectively under careful supervision, but caution must be exercised when using this procedure as anaphylaxis does occur.
“Sublingual Immunotherapy for Treatment of Poison Ivy Dermatitis.” (Abstract #P154: Nov. 11-12, Noon – 1:00 p.m.) – M.S. Morris and M. Learned, La Crosse, Wis. – Each year 10 to 50 million Americans develop an allergic reaction after contact with poison ivy according to the investigators. Results of this preliminary retrospective chart review of 115 patients indicate that sublingual immunotherapy may be a viable treatment option for decreasing sensitivity for patients with poison ivy dermatitis. Authors note that this thereapy may allow patients who have occupation or hobbies which bring them into frequent contact with poison ivy to decrease the frequency and severity of outbreaks.
METAL ALLERGY
“Systemic Delayed Hypersensitivity (DH) to Cobalt (Co) after Metal Alloy Knee Arthroplasty.” (Abstract #P6: Nov. 11-12, Noon – 1:00 p.m.) – Frederick C. Cogen, M.D., Meadowbrook, Pa. – Investigators note that joint arthroplasty with insertion of a metal alloy prosthesis is an increasing procedure in our aging population. Reporting on two cases and a cohort of 35 patients with failed knee replacements that had positive patch tests to cobalt, authors caution physicians to be aware of the entity of metal induced systemic delayed hypersensitivity following arthroplasty. They suggest patch testing may be useful in diagnosing DH in arthroplasty failures, and perhaps, in choosing the optimal implant for those with a history of DH to metals.
“Stainless Steel Allergy after the Nuss Procedure for Repair of Pectus Excavatum.” (Abstract #P195: Nov. 11-12, Noon – 1:00 p.m.) – Maripaz B. Morales, M.D., Suffolk, Va., et al – This study evaluated metal allergy and its effects on the increasing use of implantable nickel and chromium bars for minimally invasive pectus excavatum repair treatment with the Nuss procedure in pediatric patients. Investigators conclude that allergy symptoms often are misdiagnosed as infection, but require different treatment. They suggest patients with a history of metal allergy or atopy be tested and a titanium bar be used for this procedure. Because the consequences of metal allergy may include the need to replace the bar, pediatric surgeons should be aware of this occurrence.
SKIN DISORDERS, SEMEN ALLERGY
“Prevalence of Thyroid Disease and Anti-thyroid Antibodies in Patients with Chronic Idiopathic Urticaria.” (Abstract #63: Nov. 13 at 2:30 p.m.) – Yazan Said, M.D., Long Beach, Calif., and Harb Harfi, M.D., Riyadh, Saudia Arabia – Investigators characterize chronic idiopathic urticaria/angiodema (CIU/A) as recurrent or persistent urticarial lesions and/or angioedema, lasting more than six weeks, and a debilitating disease with only supportive therapy. In this study of 165 CIU/A patients, they found an increased prevalence of thyroid disease and auto-antibodies, which may support the role of auto-immunity in its pathogenesis. Authors recommend testing for thyroid function and anti-thyroid antibodies in these patients since its treatment may help control CIU/A.
“Resurgence of Bedbug Bites Misdiagnosed as Allergic Skin Rashes in Inner-City Population.” (Abstract #P199: Nov. 11-12, Noon – 1:00 p.m.) – Sreenivasrao Amara, M.D., et al, Brooklyn, N.Y. – There is an increase in reports of bites from bedbugs (Cimex lectularius), a nocturnal bloodsucking parasite, in the U.S. and worldwide. Investigators report six patients with multiple, cutaneous manifestations misdiagnosed as allergic reactions that were proven bedbug bites. They recommend health care professionals be alert to screen for bedbug bites in any patient with a new refractory rash.
“Seminal Plasma Protein Hypersensitivity: The First Case Report in a Puerto Rican Woman.” (Abstract #P32: Nov. 11-12, Noon – 1:00 p.m.) – Jennifer Collins, M.D., et al, New York, N.Y. – Human seminal plasma protein hypersensitivity is a rare and often misdiagnosed phenomenon, with 80 cases existing in the medical literature including individuals from Europe, the United States, Australia, India, Japan, Israel and Korea, according to the authors. Authors note that, to their knowledge, this investigation is the first case report of seminal plasma protein hypersensitivity in a Puerto Rican female who underwent intravaginal desensitization.
About ACAAI
The American College of Allergy, Asthma and Immunology (ACAAI) is a professional medical organization headquartered in Arlington Heights, Ill., that promotes excellence in the practice of the subspecialty of allergy and immunology. The College, comprising more than 5,000 allergists-immunologists and related health care professionals, fosters a culture of collaboration and congeniality in which its members work together and with others toward the common goals of patient care, education, advocacy and research.
American College of Allergy
85 W. Algonquin Rd., Ste 550
Arlington Heights, IL 60005
United States
http://www.acaai.org/
Add comment March 5, 2007