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San Antonio, TX , November 18, 2002 -- Data presented at the American College of Allergy, Asthma and Immunology's (ACAAI) 60th Annual Meeting showed that Flonase Nasal Spray, at the maximum recommended daily dose of 200mcg, had no significant effect on growth parameters in a one-year study in children with perennial allergic rhinitis (PAR).
The randomized, double-blind, placebo-controlled study of 150 prepubescent males and females (3.5 to 9.5 years of age) found that children who were treated with Flonase demonstrated comparable height increases and growth velocity as those who received vehicle placebo.
"Historically, there has been some concern about the potential for intranasal corticosteroid therapy with older, more bioavailable products to affect growth in children," said Dr. Eli Meltzer, of the Allergy and Asthma Medical Group and Research Center in San Diego, who presented the findings. "The results of this study clearly demonstrated that long-term use of fluticasone propionate - an intranasal corticosteroid with less than 2% bioavailability - at the maximum recommended daily dose, had no statistically or clinically significant effect on height or growth rate over the one-year treatment period in a pediatric population," added Meltzer.
Growth measures included mean standing height at the end of one year of treatment, mean changes from baseline in standing height measured monthly throughout the treatment period, and growth rate (the increase in standing height) over one year. Study results showed that the effect of Flonase on mean ending height and growth rate after one year was equivalent to the placebo controlled group. In addition, children in both treatment groups had similar increases in height over the same period.
"This research suggests that, unlike some older intranasal corticosteroids, fluticasone propionate has no adverse effect on children's growth," said Meltzer. "This is an important finding because intranasal corticosteroids are the most effective therapy for the treatment of persistent allergic rhinitis."
Over the one-year treatment period, 12% of patients in each treatment group reported at least one adverse event that was considered to be at least possibly related to study medication. The most commonly occurring drug-related adverse event, epistaxis (nosebleed), was reported among 9% of the group using Flonase and 8% of the group using placebo. No adverse events indicative of systemic drug exposure were reported.
Controlled clinical studies have shown that some intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. The growth of pediatric patients receiving intranasal corticosteroids, including Flonase Nasal Spray, should be monitored routinely (e.g., via stadiometry).
About Rhinitis
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 childreni.
Allergic rhinitis can occur seasonally or year-round. Seasonal Allergic Rhinitis (SAR) is triggered by seasonal allergens, such as tree and grass pollens. Perennial Allergic Rhinitis (PAR) occurs year-round and is triggered by allergens such as house dust mites, animal dander and molds.
Nearly half of all allergic rhinitis sufferers, which number one in five of the US populationii, experience symptoms including nasal congestion, runny nose, nasal itching, and associated symptoms of ocular burning and itching at least four months of the yeariii. In fact, nearly 70% of allergic rhinitis patients are treated for nasal congestion - the most frequently treated symptomiv. Most patients with nasal congestion do not get a good night's sleepv. Based on expert panel recommendation, when nasal congestion is a major component of rhinits, an intranasal corticosteroid is first-line therapyvi.
Perennial Non-Allergic Rhinitis (PNAR) is a nasal condition that affects an estimated 35 million Americansvii and is triggered by exposure to irritants such as smoke, strong odors and temperature changes. Symptoms typically include nasal congestion, which may be associated with a runny nose and postnasal drip throughout the year.
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 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 leading Rx antihistamine pill.
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.
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 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.
iii 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.
iv Data on file at GlaxoSmithKline.
v 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.
vi 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.
vii 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.
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