Dose-related efficacy and tolerability of fluticasone propionate nasal drops 400 microg once daily and twice daily in the treatment of bilateral nasal polyposis: a placebo-controlled randomized study in adult patients

Clin Exp Allergy. 2000 Jan;30(1):94-102. doi: 10.1046/j.1365-2222.2000.00695.x.

Abstract

Background: Topical corticosteroids are the accepted medical adjunct to surgery in patients suffering from nasal polyposis. Fluticasone propionate (FP) is a potent, topically active corticosteroid which has been formulated as nasal drops specifically for the treatment of polyposis.

Objectives: To evaluate dose-related efficacy and tolerability of FP nasal drops (FPND) in the treatment of mild to moderate bilateral polyposis; in a double-blind, placebo-controlled, multicentre international study.

Methods: Adult patients (n = 142) with bilateral nasal polyps were randomized to receive either FPND 400 microg once daily (o.d.), FPND 400 microg twice daily (b.i.d.) or placebo for 12 weeks. The majority then entered a further 12 week open period during which all patients received FPND 400 microg o.d. The primary efficacy endpoint was the physicians' visual assessment of polyp size. Secondary clinical endpoints were nasal blockage and overall rhinitis (0-3 scores), peak nasal inspiratory flow (PNIF), olfactory function tests, and requirement for polypectomy. The patients also kept twice daily records of symptom scores, peak nasal inspiratory flow (PNIF) and use of rescue medication.

Results: At the end of the 12 week randomized treatment period, polyp size was reduced significantly by FPND 400 microg b.i.d. as compared with placebo (P = 0.006). Clinical assessments of nasal blockage and overall rhinitis showed significant improvements at several stages of treatment with both doses of FPND. Clinic PNIF was also improved significantly by both doses of FPND in comparison with placebo, and FPND 400 microg b.i.d. was significantly more effective than 400 microg o.d. (P = 0.045). Patient diary card scores supported the clinical assessments. Two patients on placebo required polypectomy and all treatments were well tolerated with a similar incidence of adverse events.

Conclusion: FPND 400 microg once or twice daily is an effective and well-tolerated treatment for bilateral nasal polyposis.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Intranasal
  • Adult
  • Aged
  • Aged, 80 and over
  • Androstadienes / administration & dosage*
  • Androstadienes / adverse effects
  • Anti-Inflammatory Agents / administration & dosage*
  • Anti-Inflammatory Agents / adverse effects
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Fluticasone
  • Glucocorticoids
  • Humans
  • Male
  • Middle Aged
  • Nasal Polyps / drug therapy*
  • Nasal Polyps / physiopathology
  • Placebos

Substances

  • Androstadienes
  • Anti-Inflammatory Agents
  • Glucocorticoids
  • Placebos
  • Fluticasone