Allergy season has come earlier in some parts of the country, thanks to the unseasonable mild weather. 

And, if you haven’t started taking your preventive allergy meds, you may want to get right to it, said Dr. Stanley Fineman, an allergist and president of the American College of Allergy, Asthma and Immunology. “We’re seeing patients who started to have symptoms a month earlier than usual, in early February.” 

Last year pollen counts were barely recorded in the first week of February in Atlanta, but this year the first week of February saw numbers above 80 and as high as 250. Pollen counts above 50 are considered high.  

Though it’s worse in the South, allergy season is also arriving early in the North.

Why the early sniffles? the warmer winter can cause trees to pollinate earlier. In addition, some studies have shown that pollen season is not only getting earlier, but the pollen is getting more potent. 

“With the higher concentration of carbon dioxide in the air, plants seem to produce more potent pollen,” said Fineman, who has a private practice in Atlanta.  

Another factor causing more severe allergies is the priming factor. 

“People who are exposed early in the season to an allergen, which then goes away and then comes back a week or two later, are primed for a more severe reaction,” Fineman said. 

Making things worse for allergy sufferers, a combination of mild weather and rain can lead to an increase in mold spore counts as well.

Many people this time of year may mistake an allergic reaction to a respiratory illness like winter colds and flu. 

“Doctors have to consider that these may be allergies, not viruses,” Fineman added.

Allergists recommend that people who know they’re allergic to certain pollens start medication before allergy season starts. that may be too late for the South, but you may be able to get a headstart on allergies in the Northern states, where pollen counts haven’t gotten that high yet. 

To monitor pollen levels in your area, go to the American Academy of Allergy, Asthma & Immunology’s pollen count map. Pollen counts can not only help you avoid the outdoors when the count is high, but can help you better determine what types of pollens are triggering your symptoms.

Laurie Tarkan is an award-winning health journalist whose work appears in the new York Times, among other national magazines and websites. She has authored several health books, including “Perfect Hormone Balance for Fertility.” Follow her on Twitter and Facebook. 

March 22, 2011 12:50 PM Eastern Daylight Time 

Phase III data presented at AAAAI builds upon Sunovion legacy in respiratory therapies

MARLBOROUGH, Mass.–(BUSINESS WIRE)–Sunovion Pharmaceuticals inc. (Sunovion) today announced that data from a large scale, 671-patient, Phase III clinical study of ciclesonide nasal aerosol in a hydrofluoroalkane (HFA) formulation were presented in three separate scientific posters at the 2011 annual meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) in San Francisco, California. the data show statistically significant improvements in reflective total ocular symptom score (rTOSS) in patients treated once daily with 74 µg of ciclesonide nasal aerosol as well as statistically significant improvements in nasal symptoms of seasonal allergic rhinitis (SAR) in patients treated once daily with both 74 µg and 148 µg of ciclesonide nasal aerosol. the overall incidence of adverse events (including epistaxis) was low and comparable to placebo. furthermore, the data also demonstrated statistically significant improvements with 74 µg of ciclesonide nasal aerosol in the overall rhinoconjunctivitis quality of life questionnaire (RQLQ) vs. placebo with a difference of 0.64.

“A Post-Hoc Analysis of Asthma Control and Lung Function following Treatment with Ciclesonide 80 ?g HFA-MDI twice Daily in Subjects with Mild-to-Moderate Persistent Asthma Previously Receiving low Dose Fluticasone Propionate/Salmeterol”

the delivery system in development is designed to dispense a small volume of the fine, dry mist of ciclesonide medication to a patient’s nose. This delivery system may be able to reduce some of the sensory effects such as back-of-the-throat run-off and run-out out of the nose that sometimes occur with aqueous-based corticosteroids for the treatment of allergic rhinitis.

“These findings indicate that ciclesonide HFA nasal aerosol may offer value for patients with seasonal allergic rhinitis including symptoms such as congestion, itchy / watery eyes and itchy nose,” said Charles P. Andrews, MD, of Diagnostics Research Group and a lead investigator of this ciclesonide HFA nasal aerosol clinical study. “We are encouraged by the results and look forward to continuing our efforts to develop treatment options for allergy sufferers.”

About the Phase III Ciclesonide HFA Nasal Aerosol (CIC-HFA) SAR Study

In this Phase III, placebo-controlled, double blind, parallel group study, 671 subjects, 12 years of age or older with SAR were randomized to either CIC-HFA 74 µg (N=226), 148 µg (N=225) or placebo (N=220), administered once-daily in the morning for two weeks during the Texas Mountain Cedar pollen season.

Efficacy was evaluated by subject-reported reflective and instantaneous total nasal symptom scores (rTNSS and iTNSS) assessing the individual nasal symptoms of nasal congestion, itching, sneezing, and runny nose. Efficacy was also evaluated by subject-reported reflective and instantaneous total ocular symptom scores (rTOSS and iTOSS) assessing the individual ocular symptoms of tearing, itchy and red eyes.

furthermore, this study measured the improvement in rhinoconjunctivitis related quality of life by administering a rhinoconjunctivitis quality of life questionnaire with standardized activities (RQLQ[S]).

Results from the Ciclesonide HFA Nasal Aerosol (CIC-HFA) SAR Study Poster Presentations:

• A Study Evaluating the Efficacy and Safety of Ciclesonide Hydrofluoroalkane Nasal Aerosol in the Relief of Nasal Symptoms of Seasonal Allergic RhinitisBoth CIC-HFA 74 µg and 148 µg demonstrated a statistically significant improvement in rTNSS (P<0.0001 for both), iTNSS (P<0.001 for both) and improvements in the individual nasal symptoms of congestion, nasal itching, sneezing and runny nose.the incidence of adverse events (including epistaxis) reported from this study for both doses of CIC-HFA were low and comparable to placebo.

• An Evaluation of the Effect of Ciclesonide Hydrofluoroalkane Nasal Aerosol on the Ocular Symptoms of Seasonal Allergic RhinitisCIC-HFA 74 µg demonstrated a statistically significant improvement in rTOSS (P=0.0124) and CIC-HFA 74 µg (P<0.05) and 148 µg (P<0.05) demonstrated improvement in iTOSS and individual ocular symptoms associated with SAR.

• Results of the Rhinoconjunctivitis Related Quality of Life Questionnaire Administered to Subjects with Seasonal Allergic Rhinitis following Treatment with Ciclesonide Hydrofluoroalkane Nasal AerosolBoth CIC-HFA 74 µg (P<0.0124) and 148 µg (P-value not determined) demonstrated improvements in the overall RQLQ[S].

In addition to the ciclesonide HFA nasal aerosol data presented at AAAAI, Sunovion also presented a poster titled, “A Post-Hoc Analysis of Asthma Control and Lung Function following Treatment with Ciclesonide 80 ?g HFA-MDI twice Daily in Subjects with Mild-to-Moderate Persistent Asthma Previously Receiving low Dose Fluticasone Propionate/Salmeterol” on data pertaining to the inhaled corticosteroid (ICS) asthma therapy, ALVESCO® (ciclesonide HFA inhalation aerosol). the data indicated that ALVESCO monotherapy maintained pulmonary function as measured by FEV1 in patients with mild-to-moderate persistent asthma, who were previously treated with combination low dose ICS and Long Acting Beta Agonist (LABA) therapy.1

About Allergic Rhinitis

Allergic rhinitis, which is commonly referred to as hay fever, is a collection of symptoms, predominantly in the nose and eyes, to allergens such as dust, dander and pollen. the sensitized immune system produces antibodies to these allergens, which cause chemicals called histamines to be released into the bloodstream, causing itching, swelling of affected tissues, mucus production, hives, rashes and other symptoms. Symptoms vary in severity from person to person.2

Allergic rhinitis is estimated to affect approximately 60 million people in the United States. Specifically, it is estimated that between 10% and 30% of adults and as many as 40% of children are affected by the disease. Approximately 12 million physician office visits each year are attributed to allergic rhinitis.3

SAR, which is also often referred to as hay fever, is caused by an allergy to the pollen of trees, grasses, weeds or mold spores. Depending on the allergen, the section of the country and the pollination periods, SAR may occur in the spring, summer or fall and may last until the first frost.

some people have symptoms of rhinitis no matter what the season. This is referred to as perennial allergic rhinitis, and it can be caused by allergens such as animal dander, indoor mold, dust mites and cockroaches.4

About Sunovion Pharmaceuticals inc. (Sunovion)

Sunovion is a leading pharmaceutical company dedicated to discovering, developing and commercializing therapeutic products that advance the science of medicine in the central nervous system (CNS) and respiratory disease areas and improve the lives of patients and their families. Sunovion’s drug development program, together with its corporate development and licensing efforts, has yielded a portfolio of pharmaceutical products including LATUDA® brand lurasidone HCl, LUNESTA® brand eszopiclone, XOPENEX® brand levalbuterol HCI Inhalation Solution, XOPENEX HFA® brand levalbuterol tartrate inhalation aerosol, BROVANA® brand arformoterol tartrate inhalation solution, OMNARIS® brand ciclesonide nasal spray and ALVESCO® brand ciclesonide HFA inhalation aerosol.

Sunovion, an indirect, wholly-owned subsidiary of Dainippon Sumitomo Pharma co., ltd., is headquartered in Marlborough, Mass. More information about Sunovion Pharmaceuticals inc. is available at sunovion.com.

About Dainippon Sumitomo Pharma co., ltd. (DSP)

DSP is a multi-billion dollar, top-ten listed pharmaceutical company in Japan with a diverse portfolio of pharmaceutical, animal health and food and specialty products. DSP aims to produce innovative pharmaceutical products in the CNS field, which has been designated as the key therapeutic area and will also focus in on other specialty disease categories with significant unmet medical needs, which are designated as frontier therapeutic areas. DSP is based on the merger in 2005 between Dainippon Pharmaceutical co., ltd., and Sumitomo Pharmaceuticals co., ltd. Today, DSP has more than 7,000 employees worldwide. Additional information about DSP is available through its corporate website at ds-pharma.com.

1 Meltzer EO, Korenblat PE, Weinstein SF, et al. Efficacy and safety evaluation of ciclesonide in mild-to moderate persistent asthma previously treated with inhaled corticosteroids. Allergy Asthma Proc 30:293-303, 2009.

2 Medline plus, a service of the U.S. National Library of Medicine and the National Institutes of Health. [Internet]. Available from nlm.nih.gov/medlineplus/ency/imagepages/19319.htm. Accessed: February 25, 2011.

3 American Academy of Allergy, Asthma and Immunology (AAAAI). [Internet]. Available from http:/aaaai.org/media/statistics/allergy-statistics.asp. Accessed: February 25, 2011.

4 American Academy of Allergy, Asthma and Immunology (AAAAI). [Internet]. Available from aaaai.org/patients/gallery/rhinitissinusitis.asp. Accessed: February 25, 2011.

LATUDA is a registered trademark of Dainippon Sumitomo Pharma co., ltd. LUNESTA, XOPENEX, XOPENEX HFA and BROVANA are registered trademarks of Sunovion Pharmaceuticals inc. OMNARIS and ALVESCO are registered trademarks of Nycomed GmbH.

For a copy of this release or any recent release,visit Sunovion’s web site at sunovion.com

LOS ANGELES — People with suspected food allergies may need to submit to an oral food challenge — ingesting the food in a doctor’s office while symptoms are assessed — in order to receive an accurate diagnosis, according to new guidelines issued Monday by a consortium of food allergy experts led by the National Institute of Allergy and Infectious Diseases.

The guidelines specifically rule out attempting to diagnose a food allergy solely by skin-prick or blood tests that merely suggest an individual is “sensitized” to a particular food. those tests, however, may be combined with a medical history and physical exam and, if needed, an oral food challenge, to arrive at a diagnosis.

Adherence to the recommendations should help people discover whether they are truly allergic to certain foods, said Dr. Hugh Sampson, a professor of pediatrics at Mount Sinai School of Medicine in New York and past-president of the American Academy of Allergy, Asthma & Immunology.

“A lot of physicians order large numbers of blood tests of various foods and when they find small amounts of antibody present, they indicate to the patient that they are allergic to this food and shouldn’t ingest it,” he said. many patients, especially children, are placed on “highly restricted diets” that are probably not necessary.

Doctors use a broad range of criteria to diagnose and define food allergies. The variation has led to wildly divergent estimates of food allergies that range from 1 percent to 10 percent of the U.S. population. Most likely, about 3 percent to 4 percent of Americans have some type of food allergy, Sampson said, although the prevalence appears to be increasing. The guidelines should help identify those people and free others to expand their food choices.

The guidelines also stress that some food allergies will disappear. for example, 80 percent of children with allergies to eggs or milk will outgrow the problem.

“Each food is different, and each allergy is different,” said Dr. Amal Assa’ad, a professor of pediatrics, allergy and immunology at Cincinnati Children’s Hospital Medical Center. “Some food allergies resolve with time. We want to get the message across that food allergy needs consistent follow-up. It’s not a lifetime verdict.”

More than 30 professional groups, along with federal and lay organizations, participated in drafting the guidelines, which were published Monday in the Journal of Allergy and Clinical Immunology. The document is intended for doctors. however, the National Institute of Allergy and Infectious Diseases will release materials to help patients understand the guidelines.

The document lists tests that can be used in making a diagnosis and those that are not recommended. for example, an IgG test, which is a common test for a type of antibody, is not recommended for helping to diagnose food allergy, said Matthew Fenton, chief of the Asthma, Allergy and Inflammation Branch of the Division of Allergy, Immunology and Transplantation at the National Institute of Allergy and Infectious Diseases.

“One of the other things we’ve seen is there are a number of different diagnostic tests that are marketed,” he said. “It’s difficult to know which tests are scientifically validated. We looked deeply at which tests were most helpful.”

Other diagnostic methods are underused, Sampson said. While tests such as skin-prick tests and blood tests to detect IgE — a natural substance that increases when someone is exposed to allergens — are frequently used to indicate a food allergy, far fewer patients undergo an oral, food-challenge test.

“If you are still left in a situation where the diagnosis isn’t clear, (the guidelines) stress that the oral, food test is the only way to get at that answer,” Sampson said.

The guidelines also specify that immunotherapy treatments are not ready for prime time. Immunotherapy treatments expose a patient to the particular allergic food, such as peanuts, in small amounts in order to build tolerance for the food. While studies show immunotherapy is promising, too little is known about its safety and effectiveness at this point in time, Fenton said.

Likewise, no changes were made in existing guidelines concerning the need for people with egg allergies to avoid egg-based vaccines. however, the panel indicated that newer vaccines containing much smaller amounts of egg protein may make it feasible in the future for egg-allergic people to tolerate vaccines.

The panel also said not enough evidence exists to show that avoiding or consuming certain foods during pregnancy or while breast-feeding influences a child’s risk of developing particular food allergies.

Newswise — Millions of Americans suffer unnecessarily with itchy, gritty, watery eyes, according to allergists at the annual scientific meeting of the American College of Allergy, Asthma and Immunology (ACAAI) in Phoenix, Nov. 11-16. The underdiagnosis, undertreatment and self-treatment of eye allergies may seriously diminish quality of life, allergists say.

“For every one eye allergy medicine prescribed, 40 people are treating themselves with over-the-counter eye medicine from their local pharmacy,” allergist Leonard Bielory, MD, chair of the ACAAI Ocular Allergy Committee. “The over-the-counter product may relieve the symptoms for a short time, but long-term, these patients need to see an allergist who can develop a complete treatment plan to eliminate the disease.” Eye allergy symptoms are regularly reported as one of the top three allergy complaints, according to the Allergies in America Survey. Forty percent of adults in the United States experience eye allergies and more than 40 million bottles of eye allergy medicine are sold in the U.S. each year.

“The focus for people with allergies is usually their skin, lungs and nasal symptoms,” said Dr. Bielory. “But what people don’t realize is that the burning, itching, watery, gritty or sandy feeling they have in their eyes can and deserves to be treated. anyone with these symptoms should see an allergist to have their allergies identified and resolved.”

Common eye allergy symptoms or abnormalities are:• itching• tearing, watery• gritty, sandy feeling • burning• redness• absence of proper blinking reflex

“Physicians need to be aware of the seriousness of eye allergies,” said ACAAI Past PresidentMichael S. Blaiss, MD. “These allergies, which often go hand in hand with nasal allergies, may affect one’s capacity to enjoy activities like reading, driving, playing outdoor sports or gardening.”

To help those suffering with eye allergies, Dr. Bielory advises physicians to administer the Ocular Surface Disease Index. This is a standardized, easily performed questionnaire that allows doctors to evaluate symptoms and diagnose eye diseases such as conjunctivitis and dry eye syndrome

“This tool helps us to discover the cause, not just relieve symptoms,” said Dr. Bielory. “From there we can get to the source of the allergy and fix it with one of many treatment options available to our patients, avoidance of the allergen, pharmacotherapy (drugs or medicine), or immunotherapy (allergy shots).”

Those who suspect they may have eye allergies should get tested by an allergist – a physician who is an expert in diagnosing and treating allergies and asthma. to learn more about allergies and asthma, take a free relief self-test or find an allergist near you visit AllergyAndAsthmaRelief.org

About ACAAIThe 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.

Follow the ACAAI annual meeting on Twitter at #ACAAI2010.

The ACAAI Press Room is located in Room 121B at the Phoenix Convention Center, November 12 – 15, 2010; phone 602-514-5360, .

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