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Denver, CO, March 8, 2003 -- Data presented at the American Academy of Allergy, Asthma and Immunology's (AAAAI) 60th Annual Meeting showed that Flonase Nasal Spray, at the maximum recommended daily dose of 200mcg, was more effective than oral montelukast (10mg once daily) for relief of nasal congestion and other daytime and nighttime seasonal allergic rhinitis symptoms.
The randomized, double-blind, double-dummy study of 736 seasonal allergic rhinitis patients found that patients treated with Flonase showed significantly greater clinical improvements, based on self-rated scores of symptom severity, compared to patients treated with montelukast. Daytime symptoms rated included nasal congestion, nasal itching, runny nose and sneezing; nighttime symptoms included nasal congestion upon awakening, difficulty going to sleep and nighttime awakenings due to nasal symptoms.
"Millions of Americans complain about the discomfort of nasal congestion during allergy season. Symptoms can last for days and range from mild to severe," said Dr. Bruce G. Martin, D.O., Southwest Allergy-Asthma Center, San Antonio, Texas, and lead study author. "In fact, most patients with nasal congestion do not get a good night's sleep. The results of this study clearly demonstrated that fluticasone propionate is more effective than montelukast in relieving nasal congestion - both daytime and upon awakening - as well as other nasal allergy symptoms," added Martin.
Statistically significant differences in favor of Flonase over montelukast were observed for the mean change from baseline in daytime total nasal symptom scores (p<0.001), daytime individual nasal symptom scores (p<0.001), and for the total (p<0.001) and all three individual nighttime nasal symptom scores (p<0.02).
"These are important findings which support the use of fluticasone propionate as a first-line therapy for the treatment of nasal symptoms associated with seasonal allergic rhinitis," said Martin.
During the study, men and women in each treatment group self-administered active study medication and dummy placebo in the evening. Both medications were well tolerated throughout the treatment period. There were no differences in the incidence of adverse events between treatment groups. The most commonly-reported drug-related adverse events (headache and nose bleed) in both treatment groups, were generally mild and transient.
About Seasonal Allergic Rhinitis and Nasal Congestion
Allergic rhinitis is one of the most prevalent and chronic diseases in the United States, affecting up to 40 million people annually, including 10 to 30% of adults and 40% of children.i
Allergic rhinitis can occur seasonally or year-round. Seasonal allergic rhinitis is triggered by seasonal allergens, such as tree and grass pollens.
Nearly 70% of allergic rhinitis patients are treated for nasal congestion - the most frequently treated symptom. ii Nasal congestion occurs as part of a chain reaction when an allergen, such as pollen, lands on the mucous membranes lining the nose. Cells in these tissues release histamine and other chemicals that dilate small blood vessels in the nose. This allows fluids to escape, which causes nasal passages to swell, resulting in nasal congestion. iii
Based on expert panel recommendation, when nasal congestion is a major component of rhinitis, an intranasal corticosteroid is first-line therapy. iv
About Flonase Nasal Spray, 50mcg
Flonase (fluticasone propionate) Nasal Spray, 50mcg, is an intranasal corticosteroid spray that helps reduce inflammation and relieves the nasal symptoms associated with seasonal and perennial allergic and perennial non-allergic rhinitis in patients ages 4 and above. Flonase is the only aqueous nasal spray approved to treat the nasal congestion associated with SAR, PAR and PNAR in patients as young as 4 years of age. In fact, Flonase treats more triggers than any leadingv allergy medicine.
Flonase received FDA approval for marketing in 1994. It has been approved for use in more than 60 countries and is now the #1 prescribed brand of intranasal corticosteroid in the United States.
For best results, use Flonase daily. Results may vary. If side effects occur, they are generally mild and may include headache, nosebleed and sore throat. Flonase Nasal Spray is available by prescription only.
Flonase was developed and is marketed by GlaxoSmithKline. GlaxoSmithKline, one of the world's leading research-based pharmaceutical and health care companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer. The company is an industry leader
in respiratory research and has a broad portfolio of commercially available respiratory therapies.
Please consult full complete prescribing information.
For prescribing information or more information, please contact Robin Gaitens at GlaxoSmithKline, (919) 483-2839 or via cell (919) 271-6560, or Kim Hamilton at Marina Maher Communications, (212) 485-6848.
i Dykewicz, M., Fineman, S., "Executive Summary of Joint Task Force Practice Parameters on
Diagnosis and Management of Rhinitis." Diagnosis and Management of Rhinitis: Parameter Documents of the Joint Task Force on Practice Parameters in Allergy, Asthma, and Immunology, Joint Council of Allergy, Asthma, and Immunology. 1998;81:463-468.
ii Data on file at GlaxoSmithKline.
iii "Something In The Air: Airborne Allergens."
http://www.niaid.nih.gov/publications/allergens/symptoms.html. Accessed 19 February, 2003.
iv Taskforce on Allergic Disorders - American Academy of Allergy Asthma and Immunology. The Allergy Report, AAAAI Web site. Available at www.aaaai.org, Accessed October 8, 2000.
v Scott-Levin's SourceTM Prescription Audit (SPA) from Verispan; October 2001 - September 2002.
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