Efficacy and tolerability of fluticasone propionate nasal drops 400 microgram once daily compared with placebo for the treatment of bilateral polyposis in adults.
BACKGROUND
Chronic eosinophilic rhinosinusitis underlies a range of respiratory disorders including nasal polyposis. Surgical and medical methods are used to control polyps, with topical steroids commonly being used for their anti-inflammatory properties. Fluticasone propionate nasal drops (FPND) is a formulation developed specifically for an effective and well tolerated corticosteroid treatment of nasal polyposis.


OBJECTIVE
To assess efficacy and tolerability of FPND in the treatment of bilateral nasal polyposis in adults.


METHODS
This multicentre, randomized, parallel-group study compared FPND 400 microgram once daily (o.d.) with placebo for 12 weeks in adult patients with mild to moderate bilateral polyposis. The primary efficacy endpoint was visual assessment of polyp size by the physician at monthly clinic visits. Nasal blockage, rhinitis, peak nasal inspiratory flow (PNIF), olfactory function and requirement for polypectomy were also assessed at visits. The patients kept diary card records of symptoms, PNIF, and use of rescue antihistamine. Additional safety data were provided by a 12-week open extension, when all patients received FPND 400 microgram o.d.


RESULTS
After 12 weeks double-blind treatment with FPND (n = 52) or placebo (n = 52), polyp size was reduced in 27% and 16% of patients, respectively; clinical reduction of nasal blockage significantly favoured FPND over placebo (55% vs 22%; P = 0.002), and clinic PNIF had increased significantly with FPND (by 52 L/min vs -3 L/min for placebo; P < 0.001). Diary card measurements showed significant benefits of FPND vs placebo for daily PNIF, nasal blockage, rhinitis and use of loratadine rescue medication. Both treatments were well tolerated and no serious adverse events occurred during randomized treatment. Epistaxis was more frequent with FPND than placebo but was generally mild and did not result in withdrawals. Mean serum cortisol levels did not change significantly with either treatment.


CONCLUSIONS
This study showed FPND 400 microgram o.d. to be an effective and well tolerated treatment for bilateral nasal polyposis in adults.
Keith
P
P
McMaster University Medical Centre, Hamilton, Ontario, Canada, Päijät-Häme Hospital, Lahti, Finland, GlaxoWellcome Research & Development, UK.
Nieminen
J
J
Hollingworth
K
K
Dolovich
J
J
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000730:Androstadienes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D000068298:Fluticasone; D005938:Glucocorticoids; D006801:Humans; D008297:Male; D008875:Middle Aged; D009298:Nasal Polyps / Q000188:drug therapy*
D000730:Androstadienes; D000893:Anti-Inflammatory Agents; D005938:Glucocorticoids; D000068298:Fluticasone