Relief of sinus pain and pressure with fluticasone propionate aqueous nasal spray: a placebo-controlled trial in patients with allergic rhinitis.
Although allergic rhinitis is commonly associated most with symptoms of nasal congestion, rhinorrhea, sneezing, and itching, the symptom of sinus pain and pressure often prompts the patient to seek medical attention. The effect of fluticasone propionate on this symptom has not been studied. The purpose of this study was to compare the efficacy and safety of fluticasone propionate aqueous nasal spray to placebo vehicle in the treatment of patients with sinus pain and pressure arising from allergic rhinitis. A multicenter, double-blind, parallel-group trial was conducted in 206 symptomatic patients > or = 12 years with seasonal or perennial allergic rhinitis. Patients were treated for 14 days with either fluticasone propionate aqueous nasal spray, 200 mcg once daily, or placebo vehicle. Patients attended clinic visits and kept diary cards rating sinus pain and pressure (measured as one symptom) and nasal congestion symptoms during the study. Treatment with fluticasone propionate provided significantly greater relief of symptoms of sinus pain and pressure compared with placebo over the entire 14-day treatment period. Nasal congestion scores also were significantly reduced compared with placebo at each time point. Treatments were well tolerated, and the incidence of adverse events attributable to study treatments was similar between groups. Our data indicate that symptoms of sinus pain and pressure and nasal congestion can be significantly reduced in patients with allergic rhinitis when treated with fluticasone propionate aqueous nasal spray, 200 mcg once daily.
Ratner
Paul H
PH
HealthQuest Therapy and Research Institute, Austin, Texas, USA.
Howland
William C
WC
Jacobs
Robert L
RL
Reed
Kenneth D
KD
Goode-Sellers
Stacey T
ST
Prillaman
Barbara A
BA
Philpot
Edward E
EE
Cook
Cindy K
CK
D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000730:Androstadienes / Q000009:adverse effects / Q000627:therapeutic use*; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D004311:Double-Blind Method; D004341:Drug Evaluation; D005157:Facial Pain / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D000068298:Fluticasone; D005938:Glucocorticoids; D006801:Humans; D008297:Male; D008875:Middle Aged; D010256:Paranasal Sinuses / Q000187:drug effects* / Q000473:pathology*; D012221:Rhinitis, Allergic, Perennial / Q000150:complications / Q000188:drug therapy; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D028761:Withholding Treatment
D000730:Androstadienes; D000893:Anti-Inflammatory Agents; D005938:Glucocorticoids; D000068298:Fluticasone