title: An integrated analysis of the efficacy of fluticasone furoate nasal spray versus placebo on the nasal symptoms of perennial allergic rhinitis.
abstract: Intranasal corticosteroids are widely prescribed for the treatment of perennial allergic rhinitis (PAR). The aim of this analysis was to determine whether the beneficial effects of once-daily (q.d.) fluticasone furoate nasal spray (FFNS) effectively improved individual nasal symptoms of PAR. An integrated analysis was performed on data from three randomized, double-blind, placebo-controlled, parallel-group trials designed to evaluate the efficacy and safety of FFNS at 110 micrograms, q.d. in subjects with PAR. The analysis included 460 subjects who received FFNS and 459 who received placebo for 4 weeks. All subjects evaluated the severity of individual nasal symptoms of nasal congestion, nasal itching, rhinorrhea, and sneezing on a four-point categorical scale. The main efficacy measures included change from baseline in daily reflective total nasal symptom score (rTNSS), reflective daily scores for each individual symptom, and predose instantaneous TNSS (iTNSS). Over 4 weeks of treatment, FFNS significantly improved rTNSS, iTNSS, and the reflective scores for each individual symptom compared with placebo. The least squares (LS) mean treatment difference over weeks 1-4 between FFNS and placebo for rTNSS was -0.93, ranging from -0.20 to -0.28 for the individual nasal symptoms (p < 0.001 for all versus placebo). For the iTNSS, the LS mean treatment difference between FFNS and placebo over weeks 1-4 was -0.95 (95% CI,-1.24, -0.66; p < 0.001). FFNS at 110 micrograms q.d. effectively relieved all nasal symptoms of PAR including nasal congestion over a 24-hour period.
authors.affiliation: Clinical Statistics, Quantitative Sciences Division, Medicines Discovery and Development, Research and Development, GlaxoSmithKline, Research Triangle Park, NC, USA.
authors.forename: Wei
authors.initials: W
authors.lastname: Wu
authors.forename: Richard D
authors.initials: RD
authors.lastname: Walters
authors.forename: Gilbert A
authors.initials: GA
authors.lastname: Nadeau
authors.forename: Warren
authors.initials: W
authors.lastname: Botnick
authors.forename: Nick
authors.initials: N
authors.lastname: Broughton
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000730:Androstadienes / Q000627:therapeutic use*; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D002648:Child; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D016018:Least-Squares Analysis; D008297:Male; D008875:Middle Aged; D059085:Nasal Sprays; D016032:Randomized Controlled Trials as Topic; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000730:Androstadienes; D000893:Anti-Inflammatory Agents; D059085:Nasal Sprays; C523187:fluticasone furoate