New Data Showed Fluticasone Furoate Nasal Spray Effectively Treated Nasal Symptoms of Allergic RhinitisStudies Also Demonstrated Improvement in Eye Symptoms in Seasonal Allergic Rhinitis
SAN DIEGO, February 27, 2007 /PRNewswire-FirstCall/ -- An allergy medicine currently under review by the Food and Drug Administration was effective and well-tolerated in treating a range of nasal allergy symptoms such as congestion, sneezing, itchy and runny nose, according to clinical studies presented at the annual meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI).
In two separate Phase III clinical studies (poster #1190, 908, 910, and 906), fluticasone furoate nasal spray (FFNS) was more effective than placebo in relieving both the nasal and eye symptoms of patients 12 years and older with seasonal allergic rhinitis, commonly known as hay fever. One additional Phase III study (poster #254) among individuals with perennial allergic rhinitis -- year-round nasal allergies -- found FFNS to be more effective than placebo in relieving nasal symptoms. What's more, the symptom-relief lasted 24 hours in all three studies.
"These studies are promising for millions of patients who continue to seek relief for their allergy symptoms," said Robert Nathan, M.D., Allergy & Asthma Associates, Colorado Springs, CO, who led one of the studies. "Seasonal and perennial allergies have a significant impact on quality of life, so new, effective medications would be welcomed," he added.
The Data: Seasonal Allergic Rhinitis
Researchers presented two randomized, double-blind, placebo-controlled trials of the effect of FFNS 110 mcg once daily on nasal and eye symptoms in patients with seasonal allergic rhinitis. The results of the studies were detailed in four poster presentations.
Poster #1190 (Hampel et al.): In a study of 302 individuals, age 12 and older, allergic to mountain cedar pollen, FFNS was significantly more effective than placebo in relieving nasal congestion, itching, runny nose, and sneezing. On a validated patient-rated scale of nasal symptoms, the mean change from baseline was -3.03 for FFNS vs. -2.25 for placebo (p=0.003). FFNS was also associated with sustained 24-hour relief from nasal symptoms, as measured by the mean change from baseline in next-day pre-dose symptom scores (-2.38 for FFNS vs. -1.47 for placebo; p<0.001).
Poster #908 (Ratner et al.): In the same seasonal allergic rhinitis study of 302 patients allergic to mountain cedar pollen, FFNS was significantly more effective than placebo in relieving such eye symptoms as burning or itching, redness, and watering or tearing. On a validated patient-rated scale of eye symptoms, the mean change from baseline was -2.15 for patients in the FFNS group vs. -1.60 for patients in the placebo group (p=0.008). As with nasal symptoms, eye-symptom relief was sustained for 24 hours, as measured by mean change from baseline in next-day pre-dose symptoms scores (-1.57 for patients in the FFNS group vs. -1.05 for patients in the placebo group; p=0.009).
Poster #910 (Kaiser et al.): In a second study in seasonal allergic rhinitis -- this one in 299 patients allergic to ragweed -- treatment with FFNS was associated with significantly greater improvement in nasal symptoms compared with placebo. Using the same validated patient self-scoring system, the mean change from baseline in the total scores of nasal congestion, itching, runny nose, and sneezing was -3.55 for FFNS vs. -2.07 for placebo (p<0.001). Moreover, efficacy was sustained over 24 hours (-2.90 for FFNS vs. -1.53 for placebo; p<0.001), and the onset of relief was eight hours after the first dose (p=0.028). Maximum benefit required several days of treatment.
Lead investigator, Harold B. Kaiser, M.D., Allergy & Asthma Specialists, Minneapolis, MN, noted, "In addition to effective relief of allergy symptoms, patients may benefit from the eight-hour onset of action and sustained 24-hour symptom relief, demonstrated in the study."
Poster #906 (Lumry et al.): In the same study of 299 ragweed-allergic patients, those who received FFNS had significant improvement in eye symptoms (-2.23 for FFNS vs. -1.63 for placebo; p=0.004), that was sustained over 24 hours (-1.86 for FFNS vs. -1.30 for placebo; p=0.007). "These are the first two prospectively-designed Phase III studies to demonstrate consistent and significant improvement in eye-related allergy symptoms with an intranasal steroid," commented lead investigator William R. Lumry, M.D., Asthma & Allergy Specialists, Dallas, TX.
The Data: Perennial Allergic Rhinitis
Poster #254 (Nathan et al.): To test the effectiveness of FFNS in patients with perennial allergic rhinitis, researchers conducted a randomized, double-blind, placebo-controlled trial of once-daily FFNS 110 mcg in 302 patients. After four weeks of treatment, patients randomized to FFNS experienced significantly fewer nasal symptoms than did those who took placebo. The mean change from baseline on the validated patient self-scoring system was -2.78 for the FFNS group vs. -2.08 for the placebo group (p=0.005). FFNS patients also experienced sustained 24-hour relief, compared with those in the placebo group (-2.45 for FFNS vs. -1.75 for placebo; p=0.006).
FFNS was well-tolerated and no drug-related serious adverse events were identified in these SAR and PAR studies. The most common adverse events reported were headache and nosebleed. In both the PAR study and the mountain cedar SAR study, the most common adverse event in both groups was headache, and the most common drug-related adverse event was nosebleed. In the ragweed SAR study, headache was the most common drug-related adverse event, followed by nosebleed.
Fluticasone furoate nasal spray is an enhanced affinity intranasal corticosteroid (INS) currently in development by GlaxoSmithKline (GSK) for use in the treatment of the symptoms of allergic rhinitis. As an INS, fluticasone furoate blocks the action of inflammatory mediators early in and throughout the allergy process. FFNS has a unique, side-actuated trigger designed for ease-of-use and patient comfort. The new agent is currently under review by the U.S. Food and Drug Administration to treat the symptoms of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR).
Intranasal corticosteroids (INSs) effectively reduce the nasal inflammation that is a root cause of allergic rhinitis. By acting early and throughout the allergy process, INSs block many allergy mediators, treating the symptoms caused by nasal inflammation such as nasal congestion, sneezing, and runny or itchy nose. This class of medicine is considered first-line therapy when nasal congestion is the primary symptom of the patient's rhinitis.
About Allergic Rhinitis
Allergic rhinitis (AR), known as nasal allergies, is an inflammatory reaction of the nasal passages to allergens, such as dust mites, animal dander, mold spores, and pollens. One of the most prevalent and chronic diseases in the U.S., nasal allergies affect up to 40 million people annually, including 10 to 30 percent of adults and up to 40 percent of children. Within minutes of exposure to an allergen, immune response cells release inflammatory mediators -- such as histamines and leukotrienes -- that lead to inflammation and produce symptoms including nasal congestion, sneezing and runny or itchy nose. Seasonal allergic rhinitis, triggered by pollens, occurs during certain seasons and lasts a few weeks to a few months. Perennial allergic rhinitis, triggered by dust mites, animal dander, and mold, occurs year-round.
GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better, and live longer. For company information visit www.gsk.com.
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Posted: February 2007