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Astelin (Azelastine HCl) Nasal Spray Appears to Provide Greater Improvement in Relieving Nasal Allergy Symptoms Than Zyrtec (Cetirizine HCl)

SOMERSET, NJ -- May 11, 2005 -- A new head-to-head, peer-reviewed clinical trial demonstrated that Astelin® Nasal Spray™ (azelastine HCl), marketed by MedPointe Pharmaceuticals, provided 25 percent greater reduction in nasal symptoms than top-selling prescription antihistamine Zyrtec® (cetirizine HCl), marketed by Pfizer Inc. The new data, published in the May 2005 issue of Clinical Therapeutics, also showed that Astelin offered significantly greater improvements in allergy patients' quality of life, compared to Zyrtec.

"Patients with chronic allergies are often frustrated with allergy medications that do not work as well as they had hoped," said lead investigator, Jonathan Corren, MD, Allergy Research Foundation, Inc. "This study provided clear evidence that Astelin offered patients more relief from nasal symptoms than Zytrec and improved their overall quality of life."

The ACT I study (Azelastine Cetirizine Trial) directly compared the efficacy of Astelin versus Zyrtec in patients with moderate-to-severe allergic rhinitis in order to determine which prescription antihistamine was more effective in improving nasal symptoms of seasonal allergic rhinitis. The ACT I study examined the efficacy of Astelin or Zyrtec against common allergy symptoms, including runny nose, sneezing, nasal itching and nasal congestion.

These symptoms collectively were directly measured as the Total Nasal Symptom Score (TNSS). In the ACT I study, patients experienced improvements in TNSS while taking either Astelin or Zytrec; however, patients taking Astelin showed an overall greater improvement in TNSS compared to those taking Zyrtec. The average improvement in TNSS for Astelin was 5.56 (29.3%) compared with 4.32 (23.0%) with Zyrtec, which was significant (P =.015).

In the assessment of onset of action over four hours, the TNSS was significantly improved from baseline in both treatment groups 15 minutes after initial administration (P <.001). The difference between Astelin and Zyrtec was significant at 60 and 240 minutes (both, P =.040). At no time point during the four-hour observation period did the improvement in TNSS with Zyrtec exceed that with Astelin.

Using the Rhinitis Quality of Life Questionnaire (RQLQ), the standard tool of measurement, the ACT I study showed that Astelin offered statistically significant improvements (P = 0.049) in quality of life benefits compared with Zyrtec. "This study once again confirms the efficacy of Astelin and reaffirms the benefit of a topically administered antihistamine," said Paul Edick, President of MedPointe Pharmaceuticals.

ACT I Study Design
Conducted during the 2004 fall allergy season at 20 investigational centers in major geographic regions throughout the U.S., the ACT I trial was a two-week, randomized, double-blind study involving 307 patients with moderate-to-severe allergic rhinitis. Participants were males and females 12 years of age and older with a two-year history of seasonal allergic rhinitis and a documented positive allergy skin test during the previous year. Following a one-week placebo lead-in period, patients were randomized to Astelin two sprays per nostril twice daily plus placebo tablets or Zyrtec 10-mg tablets once daily plus placebo (saline) nasal spray for the two-week, double-blind treatment period. Patients recorded symptoms twice daily in diary cards during the two-week treatment period.

Both Astelin and Zyrtec were well tolerated in the ACT I study. The most common adverse event, or side effect, experienced with Astelin was bitter taste (3.3 %). The most common side effect of Zyrtec was drowsiness (2.6%).

Impact of Allergies
Allergic rhinitis is the fifth most prevalent chronic disease in the United States, affecting up to 40 million adults and children each year. Allergic rhinitis costs the nation approximately $5.3 billion in direct and indirect costs (including time lost from work and school) and accounts for about 10,000 absences from school.

Twenty percent of the U.S. population suffers from seasonal allergies, which are caused by pollen, spores, and other allergens. Millions of Americans suffering from seasonal allergies also may be sensitive to environmental triggers such as air pollution, cigarette smoke, and cleaning solutions. It is critical that patients seek proper diagnosis with physicians to determine which type of allergies they suffer from to determine the best treatment options.

Additional Information About Astelin

Astelin, the only prescription antihistamine approved by the Food and Drug Administration to treat symptoms of seasonal allergic rhinitis and nonallergic vasomotor rhinitis, is the fastest-growing antihistamine in new prescriptions in the past year.

Astelin is indicated for the treatment of the symptoms of seasonal allergic rhinitis (in patients 5 years of age and older) and nonallergic vasomotor rhinitis (in patients 12 years of age and older). Astelin is well tolerated and relieves the full range of rhinitis symptoms, including difficult-to-treat nasal congestion. The most commonly reported adverse events in seasonal allergic rhinitis and nonallergic vasomotor rhinitis patients 12 years of age and older were bitter taste, headache, somnolence, and nasal burning. The adverse event profile in seasonal allergic rhinitis patients 5 to 11 years of age was similar to that in the adult population.

Digestive Allergic Disorder Rising in Kids     HealthDay
August 25, 2004 02:03:56 PM PDT , HealthDay
By E.J. Mundell
HealthDay Reporter
WEDNESDAY, Aug. 25 (HealthDayNews) -- An allergic inflammatory disease of the esophagus triggered by immune cells may be on the rise among U.S. children, a new study finds.

The chronic disorder, called eosinophilic esophagitis (EE), is characterized by irritation and inflammation of the esophagus, the tube that carries food from the throat to the stomach. As the esophagus narrows, children with EE suffer discomfort and difficulty when swallowing food, and vomiting is not uncommon.

Rates for the disease appear to be on the rise. The percentage of children affected with EE may now outrank those with better-known gastrointestinal ailments such as Crohn's disease or ulcerative colitis, according to the study.

The findings are published in a research letter in the Aug. 26 issue of the New England Journal of Medicine.

"Our study found a considerable rise in cases, especially in the past few years," said lead researcher Dr. Marc E. Rothenberg, director of allergy and immunology at Cincinnati Children's Hospital Medical Hospital.

His team reviewed data from the hospital's pathology lab database dating back to 1991. The hospital is the single provider of pediatric gastroenterology care for the greater Cincinnati area, so a review of former patients would give the researchers a sense of any local changes in the incidence of EE.

They identified 315 cases of confirmed disease among pediatric patients, "with only 2.8 percent having been identified before 2000," Rothenberg said. Many of the cases were clustered in families, usually among siblings. This could point to "either genetic links or shared environment" as possible factors, he said.

By the end of 2003, more than four of every 10,000 children in the Cincinnati area were estimated to suffer from EE -- a number similar to that of more common chronic gastrointestinal ailments.

"What's new about this report about eosinophilic esophagitis is that it had been a previously under-appreciated syndrome," said Dr. Lanny J. Rosenwasser, professor of medicine and allergy at the National Jewish Medical and Research Center in Denver. "Its prevalence is really exploding now that it's being recognized, especially in the pediatric age group."

Rosenwasser said it's hard to figure out whether the condition is simply being detected more often or whether there has been a sharp increase in new cases, as has been the case with other allergic conditions, such as asthma. "Some of it may be that people haven't been aware of it," he said. "But it may be that allergic diseases in general are increasing in prevalence, too."

The disease isn't confined to children, either. "It's possible that many cases of GERD in adults are [undiagnosed] EE, that's been unexplored as of yet," Rosenwasser said.

EE is characterized by the abnormal proliferation in the esophagus of eosinophils, which are inflammatory immune cells. Because symptoms often mimic those of gastrointestinal esophageal reflux disorder (GERD), EE is often mistaken for pediatric GERD.

"It's probably misdiagnosed very easily," Rosenwasser said. "I don't know how many doctors are aware of it. It's probably not on the radar screen for many primary-care physicians."

In fact, Rothenberg said, "many patients wait for years before a correct diagnosis is made. Once a proper diagnosis is established, children are treated with antacids and proton pump inhibitor drugs (like Prilosec) to help ease gastrointestinal symptoms, and anti-allergy drugs to help fight the underlying cause of the disorder.

Rothenberg stressed that more study needs to be done to see if the sudden rise in EE is occurring elsewhere in the nation. "It could be something specific to this area," he said.

Scientists need to learn much more about the causes of this emerging threat, as well. "We have to find out why these eosinophils are collecting in the esophagus," Rosenwasser said, "to get a better understanding of their basic biology."

Allergies of the eye: how to relieve redness and itching
Charles H. Feldman, M.D., FAAAAI
Red, itchy eyes and irritated, puffy eyelids occur very frequently, especially among children with hay fever. The good news is that new treatments are now available to control these allergic conditions.
Allergic conjunctivitis is the most common allergy affecting the eyes. The conjunctivae—the thin membranes covering the eyelids and the exposed surface of the eyes—is an active tissue of the immune system that responds to allergies caused by airborne particles, or allergens.
Allergic conjunctivitis can appear in two forms: seasonal and perennial. The seasonal version is much more common, and is related to exposure to specific airborne allergens, such as grass, tree and weed pollens and molds. The perennial form persists throughout the year and is usually triggered by dust mites, animal dander and feathers.
The primary immediate response to allergens touching the eye is the release of histamine by the body’s mast cells, which are the main cells involved in allergic reactions. While eye reactions can occur alone, they are usually associated with nasal symptoms. Typical allergic conjunctivitis symptoms include one or more of the following:
itching of the eyes and the surrounding area;
red, swollen conjunctivae;
profuse tearing and watery secretions;
stinging or burning;
and swollen eyelids, usually on both sides.
If there is prolonged itching of the eyes or if the secretions appear to have pus, an eye infection could be appearing as a complication. The eyes are not sensitive to light during the reaction. Very rarely, permanent visual impairment may result.
There are several components in the treatment of allergic conjunctivitis:
Avoid the allergen.
Use cold compresses for significant relief from eye itching. Generally, all eye medicines, if refrigerated, provide additional relief when immediately applied in a cold state.
Use tear substitutes ("artificial tears") to lubricate, dilute and remove allergens in the eyes.
Use prescribed medications.
Topical eye medications, over-the-counter (OTC) decongestants, prescription antihistamines, mast cell stabilizers and anti-inflammatory drugs are all used for the treatment of allergic conjunctivitis, but there are some differences.
Topical antihistamines (drop form) are effective, with levocabastine (Livostin) having rapid onset of action and prolonged protection. Additionally, several mast-cell stabilizer medications are available. Lodoxamine (Alomide) can be effective, and nedocromil (Zaditor) and cromolyn (Crolom) inhibit mast cells and provide clinical relief. Olopatadine (Patanol) has dual action as a mast cell inhibitor and antihistamine. It provides clinical relief and can be used in children above 3 years. This group of medicines shows the greatest potential for relief of the symptoms of allergic conjunctivitis. Ketorolac (Acular) is a non-steroidal anti-inflammatory drug which blocks production of the allergy mediators, prostaglandins, and relieves itching and burning. This can also be effective.
You may also be tempted to use OTC topical decongestants which claim to relieve eye-related symptoms as well. However, these medications can have potentially serious adverse effects and are not always effective. In addition, oral antihistamines alone often do not provide adequate relief. And while corticosteroids are effective medicines in the treatment of hay fever, they are too potent for routine use in allergic conjunctivitis. Due to potential side effects, their use is limited to extreme situations.
If you’re experiencing symptoms of allergic conjunctivitis, see your allergist/immunologist, who will prescribe the best treatment for you.
Other eye rashes
Because the skin of the eyelid is thin, soft and pliable, there is increased susceptibility to swelling and redness with minor degrees of inflammation. Contact dermatitis is the most common cause of a rash of the eyelid and surrounding area.
The most frequent trigger of this rash is cosmetics applied to the hair, face or fingernails. The sites to which these cosmetics are applied may not be affected at all, but the eye area is. This is especially true for hair dye and nail polish.
The typical onset of this eye rash occurs when cosmetics are applied on or near the eyelids. Symptoms can include stinging and burning of the eyes and eyelids. The lids become red, thickened and scaly in appearance. The treatment is to identify and eliminate the suspected sensitizer and then apply a topical corticosteroid (cream) to the eyelid and surrounding area.
Allergies of the eye can be extremely disturbing, but with the help of an allergist/immunologist, symptoms can be prevented and controlled.
Charles H. Feldman, M.D., FAAAAI, is a Fellow of the Academy and member of the AAAAI Public Education Committee. He practices allergy/immunology in Teaneck, NJ.

Allergy: Keeping Your Home Allergen-Free
For people with allergies, a few simple steps can go a long way in helping keep the home environment as free of allergens as possible. Such steps can make a big difference in quality of life for allergy sufferers by reducing everyday exposure to allergens and other irritants. Start in the bedroom, where most people spend a third of their time, and then work your way through each room in the house.

Wash sheets, pillowcases, and blankets in hot water weekly. Keep pillows and mattresses encased in dust-proof covers.
If possible, replace carpets with hardwood, linoleum, or washable area rugs. If that's not possible, vacuum frequently with a vacuum that has a HEPA filter.
Replace horizontal blinds with washable curtains or washable roller-type shades.
Choose furniture that is easy to clean and is not upholstered. Choose leather, wood, metal, or plastic for dressers and nightstands.
Keep the room free of clutter or anything that collects dust, including books, knick-knacks, and photo frames. Store toys, games, and plush toys in plastic bins.
Keep pets out of the bedroom and bathe them weekly.
Buy an air filter, especially one with a HEPA or small-particle filter.
Living room
Replace carpets with hardwood, linoleum, or washable area rugs. If that's not possible, vacuum frequently with a vacuum that has a HEPA filter. Wash rugs weekly and keep floors swept and mopped.
Replace upholstered furniture with a sofa and chairs made of leather, wood, metal or plastic.
Replace horizontal blinds with washable curtains or washable roller-type shades.
Keep windows closed and use air conditioning during pollen season. Check window frames for condensation and clean any mold or mildew you find.
Keep potted plants out of the house; if that's not possible, spread aquarium rocks over the dirt to contain mold.
If you have a pet and don't want to find a new home for it, try to keep it outdoors as much as possible. Vacuum and dust frequently to minimize pet dander.
Use a stovetop exhaust fan to get rid of cooking fumes and humidity. Be sure to use a hood that vents outside instead of just filtering cooking particulates.
Don't let dirty dishes accumulate in the sink; keep the sink clean and faucet clean and free of mold and food particles.
Keep countertops and cabinets free of water and excessive moisture. Use hot water and detergent to clean all surfaces.
Throw away food in the refridgerator that is moldy or past its pull date. Wipe up excessive moisture to prevent mold and mildew, and wipe up any spills on refridgerator shelves. Keep the dripping pan clean and replace any refridgerator door seals that are crumbling or moldy.
Check under the sink and all lower cabinets for plumbing leaks.
Keep food (especially pet food) stored in plastic containers.
Make sure the garbage can has a well-fitting lid that keeps out insects, and take out the trash daily.
If your bathroom doesn't have an exhaust fan, install one to reduce moisture during baths or showers. Keep the fan running 10-20 minutes after your shower to make sure all moisture has dissipated.
Take out any carpet and replace it with wood, linoleum, tile, or any other easily washable flooring. Using washable rugs.
Use mold-resistant enamel paint and replace any wallpaper with tile or painted walls.
Dry the tub, surrounding wall, and shower door (if you have one) after every shower. This will keep mold from accumulating on the tub and plumbing fixtures. Clean or replace moldy shower curtains and bathmats.
Scrub mold from plumbing fixtures, and keep the toilet and sink clean. Fix any leaks.
Replace carpeting with cement, linoleum, or any easily washable flooring. If that's not possible, vacuum frequently using a vacuum with a HEPA filter. Put plastic sheeting (vapor barrier) under carpets to prevent moisture seepage.
Replace upholstered furniture with a sofa and chairs made of leather, wood, metal or plastic.
Repair any water leaks or damage in the foundation, windows and stairwells.
Run a dehumidifier and clean it weekly.
Store collectibles and clothes in plastic containers.
Use an exhaust fan on your clothes dryer to vent moisture outside.
All over the home
Keep your house from becoming a hot, humid breeding ground for dust mites and mold. Keep the temperature at 70 degrees and relative humidity at 30 percent to 50 percent. Keep air ducts clean, and replace furnace and air-conditioning filters at least once a month, or as directed on the filter.
Hire an exterminator if your home has cockroaches or mice, as their residue can trigger allergy symptoms. To control any other insect residue (such as from fleas), vacuum carpets and rugs frequently, and wash hard surfaces with detergent and water. Seal cracks and any other areas where insects can enter your home.
To prevent mold, keep windows and doors closed and use air conditioning. Run a dehumidifier in each room, and keep them clean. Remove any carpet with mold in it. If that's not possible, wash it and any other washable material with a solution of 5 percent chlorine bleach. Wear a protective mask when cleaning away mold.
Establish a weekly cleaning routine that involves wet-washing hard flooring surfaces and vacuuming all carpeting and rugs. When dusting, use a damp cloth, and don't forget the tops of doors, windowsills, and window frames. If possible, have someone other than the allergic person do these tasks. If you are allergic, wear a dust mask if you must do these jobs.
Forbid smoking anywhere in the house.

Certain foods may make you more sensitive to tree pollens, and vice versa.
Foods to avoid during the tree(spring) season.
•apples, •celery,