Overview

Inhaled Budesonide and Acute Mountain Sickness

Status:
Completed
Trial end date:
2016-10-01
Target enrollment:
Participant gender:
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
Phase:
Phase 1
Details
Lead Sponsor:
Salzburger Landeskliniken
Collaborator:
University Hospital Heidelberg
Treatments:
Budesonide