NEW ORLEANS, Nov. 10 /PRNewswire/ -- Azelastine hydrochloride (ASTELIN(R) Nasal Spray) may improve nasal congestion in patients with symptomatic seasonal allergic rhinitis, according to an open-label pilot study presented today by researchers from the Allergy and Asthma Medical Group and Research Center (AAMGRC) at the annual meeting of the American College of Allergy, Asthma & Immunology (ACAAI).
"Oral antihistamines are effective in treating most symptoms of seasonal allergic rhinitis, but are generally marginally effective in relieving nasal congestion, the number-one complaint of allergy sufferers," said Eli O. Meltzer, M.D., clinical professor of pediatrics, University of California at San Diego, co-director and principle investigator from the Allergy and Asthma Medical Group and Research Center. "Our study found that the azelastine nasal spray provides both the benefits of a traditional second-generation antihistamine and measurably reduces nasal obstruction."
The open-label study enrolled 30 patients with seasonal allergic rhinitis to determine whether the intranasal antihistamine azelastine would improve nasal congestion. The study consisted of a one-week screening period, followed by a one-week treatment period with azelastine nasal spray. Patients were qualified for enrollment using the Total Nasal Symptom Score (TNSS) and were measured before and during treatment using nasal peak inspiratory flow rates (nPIFR).
Study results showed statistically significant (P<.05) improvements from the baseline nPIFR were observed beginning at 30 minutes after administration of azelastine nasal spray and continuing at each time interval up to 120 minutes. In addition, a statistically significant improvement from baseline was seen after seven days of treatment with azelastine nasal spray.
"We are encouraged by these preliminary results, and believe they warrant further investigation to evaluate the efficacy of azelastine nasal spray in relieving nasal congestion in a larger patient population," said Dr. Meltzer.
These new data follow two studies -- one also presented at this week's ACAAI meeting, and another published in the August 2003 issue of Annals of Allergy, Asthma and Immunology -- showing that intranasal administration of azelastine hydrochloride provided relief of allergy symptoms in patients who experience unsatisfactory relief from either the oral antihistamine fexofenadine hydrochloride (Allegra(R)) or loratadine (Claritin(R)), respectively.
Allergic Rhinitis
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 on a typical school day. It also can lead to a number of complications, including sinusitis, Eustachian-tube dysfunction, sleep disturbances, asthma, and ear infections.
Physicians can use a variety of tests to diagnose allergic rhinitis, including in vitro lab testing, scratch or puncture tests and intradermal tests. Once diagnosed, there are three main approaches for managing the disease: environmental control, pharmacotherapy and immunotherapy. Avoidance of the allergen(s), when possible, helps manage allergic rhinitis. Drug therapy, also known as pharmacotherapy, is particularly important because complete avoidance is often difficult.
Current prescription or over-the-counter treatments include oral and intranasal antihistamines, intranasal corticosteroids, mast-cell stabilizers, oral and intranasal decongestants and leukotriene-receptor antagonists. If a physician concludes that avoidance and pharmacotherapy do not provide sufficient relief and if the symptoms are severe enough, he/she may suggest desensitization or immunotherapy.
About ASTELIN (azelastine hydrochloride) Nasal Spray, 137 mcg
ASTELIN is indicated for the treatment of the symptoms of seasonal allergic rhinitis (patients 5 years of age and older) and nonallergic vasomotor rhinitis (patients 12 years of age and older).
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. Discontinuation rates due to adverse events in patients taking ASTELIN Nasal Spray in the seasonal allergic rhinitis and nonallergic vasomotor rhinitis clinical trials were no different than those for placebo.
Please see full prescribing information available at http://www.astelin.com/ About MedPointe Pharmaceuticals
MedPointe Pharmaceuticals is a privately held, specialty pharmaceutical company located at 265 Davidson Avenue, Suite 300, Somerset, New Jersey, 08873-4120; 732-564-2200. MedPointe specializes in respiratory, allergy, central nervous system, cough-cold, and pediatric products. The company maintains a manufacturing facility in Decatur, Illinois. For more information on MedPointe, visit http://www.medpointepharma.com/.
For additional information and/or full Prescribing Information on ASTELIN(R) (azelastine hydrochloride) Nasal Spray, 137 mcg, please call 1-800-598-4856 or visit http://www.astelin.com/.
Contact information: Jamie DiGiovanni MCS Public Relations (800) 477-9626 jamieD@mcspr.com
MedPointe PharmaceuticalsCONTACT: Jamie DiGiovanni, MCS Public Relations, 1-800-477-9626,jamieD@mcspr.com, for MedPointe Pharmaceuticals
Web site: http://www.medpointepharma.com/
