A double-blind comparison of intranasal budesonide with placebo for nasal polyposis

J Allergy Clin Immunol. 1990 Dec;86(6 Pt 1):946-53. doi: 10.1016/s0091-6749(05)80158-7.

Abstract

Intranasal budesonide, 400 micrograms two times a day, was evaluated in 36 patients referred for treatment of nasal polyposis. The age range was 20 to 68 years. Polypectomy was done 5.6 (mean) times previously. After a 5-week, treatment-free, baseline period, patients were treated in a double-blind fashion with either budesonide or placebo during 4 weeks. After this treatment period, placebo-treated patients started receiving budesonide in an open trial for an additional 4 weeks. The patients rated their nasal symptoms daily. Nasal examinations and nasal inspiratory flow rate (IFR) measurements were done at clinic visits. After 3 and 4 weeks of treatment, the response to budesonide was significantly greater than response to placebo. The greater reduction in nasal blockage caused by polyps, observed on physical examination, p = 0.005, was mirrored by an increase in nasal IFR (p = 0.0001). Patient rating of the severity and frequency of nasal blockage were reduced more by budesonide than by placebo (p less than or equal to 0.0005). Switching placebo-treated patients to budesonide treatment resulted in a reduction of nasal blockage (p less than 0.001) and an increase in nasal IFR (p less than 0.001). The results demonstrate that topical nasal budesonide, 400 micrograms two times a day, is an effective treatment of nasal polyps.

Publication types

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

MeSH terms

  • Administration, Intranasal
  • Budesonide
  • Double-Blind Method
  • Glucocorticoids / therapeutic use
  • Humans
  • Nasal Polyps / drug therapy*
  • Nasal Polyps / physiopathology
  • Patient Compliance
  • Placebos
  • Pregnenediones / adverse effects
  • Pregnenediones / therapeutic use*
  • Pulmonary Ventilation

Substances

  • Glucocorticoids
  • Placebos
  • Pregnenediones
  • Budesonide