Placebo-controlled, randomized, double-blind study evaluating the efficacy of fluticasone propionate nasal spray for the treatment of patients with hyposmia/anosmia

Acta Otolaryngol. 2003 Sep;123(7):862-8. doi: 10.1080/00016480310002140.


Objective: To compare the effect on olfaction of topical glucocorticoid treatment versus placebo given for an extended period in addition to oral short-term glucocorticoids in patients with anosmia/hyposmia.

Material and methods: This was a randomized, double-blind, placebo-controlled study. The criterion for inclusion in the blinded phase was an improvement of at least 2 steps in the butanol odor threshold test following open treatment for 10 days with oral and nasal corticosteroids. Forty patients were included: 20 were randomized to treatment with fluticasone propionate, 10 to placebo and 10 others as controls. The topical treatment was continued for 6 months.

Results: The 3 groups showed similar improvements in their sense of smell after the initial 10-day treatment with combined oral and nasal corticosteroids. Patients who continued the local treatment maintained the same level of improvement throughout the study, whether or not they had been given nasal corticosteroids or placebo. We found no significant differences between the treatment groups.

Conclusions: In patients with anosmia/hyposmia partly caused by local inflammation, no further improvement in the olfactory threshold is achieved by continuing with a topical intranasal glucocorticoid after an initial combined topical and systemic glucocorticoid treatment.

Publication types

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

MeSH terms

  • Administration, Topical
  • Adolescent
  • Adult
  • Androstadienes / pharmacology
  • Androstadienes / therapeutic use*
  • Anti-Inflammatory Agents / pharmacology
  • Anti-Inflammatory Agents / therapeutic use*
  • Double-Blind Method
  • Female
  • Fluticasone
  • Humans
  • Male
  • Middle Aged
  • Olfaction Disorders / drug therapy*
  • Olfaction Disorders / physiopathology
  • Smell / drug effects*
  • Tomography, X-Ray Computed
  • Treatment Outcome


  • Androstadienes
  • Anti-Inflammatory Agents
  • Fluticasone