Flunisolide nasal spray 0.025% in the prophylactic treatment of nasal polyposis after polypectomy. A randomized, double blind, parallel, placebo controlled study.
This double blind, parallel study compared flunisolide 2 X 25 mcg in each nostril twice daily, with placebo in the prophylaxis of nasal polyposis recurrence after surgery. The treatment lasted for 12 months. The study was conducted according to the recommendations of the Declaration of Helsinki, and the patients gave verbal consent to participate. The study was reviewed by the Norwegian Medicines Control Authority. Forty-one patients with first or recurrent polypectomy were enrolled. Thirty-seven patients completed the 12 months' period. Four patients dropped out prematurely for reasons unrelated to the test drug. Flunisolide was significantly superior to placebo in preventing recurrence of polyps during 6 to 12 months' treatment, both with respect to number (p = 0.05) and size (p = 0.03) of polyps. Nasal symptoms of sneezing and stuffiness decreased significantly for flunisolide treated patients during treatment. In the placebo group, there was a significant increase in stuffiness throughout the year. For runny nose, there was no difference between the treatments. Six flunisolide patients and 10 placebo patients reported side effects during the one year treatment, transient mild itching being the most common complaint. Three cases of secretion with bloody traces were reported. No patient withdrew for drug related reasons. In this study, flunisolide was significantly more effective than placebo in preventing recurrence of nasal polyposis during one year's treatment after polypectomy.
D000293:Adolescent; D000336:Aerosols; D000368:Aged; D004341:Drug Evaluation; D005446:Fluocinolone Acetonide / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000627:therapeutic use; D006801:Humans; D008297:Male; D009298:Nasal Polyps / Q000517:prevention & control* / Q000601:surgery; D011184:Postoperative Period; D012008:Recurrence
D000336:Aerosols; D005446:Fluocinolone Acetonide; C007734:flunisolide