Clinical Trial: Inhaled Budesonide and Acute Mountain Sickness

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional



Official Title: Effect of Inhaled Budesonide on the Incidence and Severity of Acute Mountain Sickness at 4559 m

Brief Summary:

The primary objective of the study is to investigate the effect of inhaled budesonide on the incidence of AMS. The primary study question to ask is:

1. Does inhaled budesonide reduce the incidence of AMS after rapid and active ascent to 4559 m?

In addition, the secondary study questions to ask are:

  1. Does inhaled budesonide reduce the severity of AMS after rapid and active ascent to 4559 m?
  2. Are the effects of inhaled budesonide on AMS incidence and severity related to its plasma concentration?

Study medication Inhaled budesonide at 2 different concentrations (2 x 200 µg, 2 x 800 µg) versus placebo

Study design

  • Prospective, controlled, single-center study on 51 healthy volunteers at 4559 m [Capanna Regina Margherita (Margherita Hut), Italy]
  • With regard to the intervention (inhaled budesonide) double-blinded and randomized