NEW ORLEANS, Nov. 10 /PRNewswire/ -- Azelastine hydrochloride (ASTELIN(R) Nasal Spray) provides effective symptomatic relief in patients with moderate to severe seasonal allergic rhinitis who have had an unsatisfactory response to treatment with fexofenadine hydrochloride (Allegra(R)), according to data presented this weekend at the annual meeting of the American College of Allergy, Asthma & Immunology (ACAAI).
“Results from this study are consistent with recent comparison data showing that the intranasal antihistamine azelastine hydrochloride is an effective therapeutic option for patients who fail to find satisfactory symptom relief with both prescription and over-the-counter oral antihistamines,” said Craig LaForce, M.D., Medical Director, North Carolina Clinical Research.
The multicenter, placebo-controlled, double-blind trial enrolled 334 patients who had experienced unsatisfactory results on fexofenadine monotherapy for a seven-day period immediately prior to the start of the trial. Study subjects were divided into three groups for a two-week period, using azelastine nasal spray and oral placebo, azelastine nasal spray and fexofenadine, or placebo nasal spray and oral placebo.
Study results demonstrated that patients treated with azelastine nasal spray showed an improvement in their overall Total Nasal Symptom Score (TNSS), experiencing statistically significant symptom relief compared to placebo.
This new data follows a study published in the August 2003 issue of Annals of Allergy, Asthma and Immunology, showing that intranasal administration of azelastine hydrochloride was an effective therapeutic option for patients who experienced unsatisfactory relief from their moderate to severe allergic rhinitis symptoms with the oral antihistamine loratadine (Claritin(R)).
“Our findings add to the growing body of clinical data that validates the efficacy of azelastine nasal spray for seasonal allergic rhinitis,” said Dr. LaForce.
The TNSS measurement tool -- defined as the sum of individual symptom severity scores for runny nose, sneezing, itchy nose, and nasal congestion -- determined drug efficacy. After two weeks of treatment, the mean percentage change in the overall TNSS from baseline with azelastine was significantly greater than that of placebo. The study also found the combination of azelastine and fexofenadine showed no additional clinical benefit compared to azelastine monotherapy.
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/ North Carolina Clinical Research
North Carolina Clinical Research (NCCR) is an independent, multitherapeutic outpatient clinical research site with locations in Raleigh and Chapel Hill, North Carolina. NCCR has conducted phase I, II, III, and IV clinical trials since 1986, completing over 300 studies in a variety of therapeutic areas for approximately 60 different pharmaceutical companies and Clinical Research Organizations.
Contact: Craig F. LaForce, M.D. Karen D. Dunn, M.D. Tel: 919-881-0309 Fax: 919-783-9406 pattib@nccr.com
North Carolina Clinical Research
CONTACT: Craig F. LaForce, M.D., or Karen D. Dunn, M.D., both of NorthCarolina Clinical Research, +1-919-881-0309, Fax, +1-919-783-9406,pattib@nccr.com
Web Site: http://www.astelin.com/
