By Sandra Ripley Distelhorst
SEATTLE -- November 10, 2008 -- The inhaled corticosteroid fluticasone furoate 110 mcg provided better relief of nighttime symptoms of seasonal allergies than the nonsedating oral antihistamine fexofenadine 180 mg, according to a study presented at the American College of Allergy, Asthma, & Immunology (ACAAI) annual conference.
This double-blind, double-dummy, multicentre study, conducted during the 2007 ragweed season in the central and eastern United States, was presented here on November 9 by co-investigator N. J. Amar, MD, Allergy and Asthma Center, Waco, Texas.
A total of 680 patients aged 12 years or more and diagnosed with ragweed allergy were randomised to receive 1 of 3 treatment regimens once daily for 2 weeks: fluticasone furoate nasal spray 110 mcg (n = 224); fexofenadine 180 mg (n = 227); or placebo (n = 229).
Efficacy of treatment was determined using various outcomes, including patient responses on a nighttime symptom questionnaire, peak nasal inspiratory flow (PNIF), and subject-rated nasal and ocular symptoms.
Dr. Amar presented summary data as the mean change from baseline. Data showed that fluticasone was more effective than fexofenadine at reducing nighttime symptoms, with a significant difference of -0.9 (P < 0.001).
Morning PNIF increased significantly from baseline in the fluticasone group compared with the fexofenadine group (10.6, P < .001).
For nasal symptoms, a significant difference was seen from baseline between fluticasone and fexofenadine in the 12-hour nighttime reflective (-1.3, P < .001) and instantaneous (-1.5, P < 0.001) total nasal scores.
For ocular symptoms, a significant difference was seen in 12-hour nighttime reflective (-0.6, P = 0.002) and instantaneous (-0.6, P = 0.002) total ocular symptom scores.
Dr. Amar reported that fluticasone did better overall when compared with placebo and fexofenadine for nighttime symptoms (P < .034 vs P >= .176, respectively).
Compared with fexofenadine and placebo, fluticasone significantly improved nighttime nasal symptoms of seasonal allergy, with a corresponding increase in morning PNIF.
Fluticasone also showed statistically significant improvement over both fexofenadine and placebo with respect to all subject-rated nasal and ocular symptom assessments.
Dr. Amar noted that there were no serious adverse events, the most common being headache, pharyngolaryngeal pain, and epistaxis.
Funding for this study was provided by GlaxoSmithKline.
[Presentation Title: Fluticasone Furoate Nasal Spray Provides Better Relief From the Nighttime Symptoms of Seasonal Allergic Rhinitis (SAR) Than Oral Fexofenadine. Abstract 30]
E-Mail this DGDispatch to a colleague
