Inhaled Budesonide and Acute Mountain Sickness

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

Timeline

Start

2016-06

Primary completion

2016-07

Completion

2016-10

Publications

• Berger MM, Macholz F, Sareban M, Schmidt P, Fried S, Dankl D, Niebauer J, Bartsch P, Mairbaurl H. Inhaled budesonide does not prevent acute mountain sickness after rapid ascent to 4559 m. Eur Respir J. 2017 Sep 10;50(3):1700982. doi: 10.1183/13993003.00982-2017. Print 2017 Sep. No abstract available.

Drugs

Indications