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:
- Does inhaled budesonide reduce the severity of AMS after rapid and active ascent to 4559 m?
- 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
Detailed Summary:
Primary objective
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:
- Does inhaled budesonide reduce the severity of AMS after rapid and active ascent to 4559 m?
- 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 budensoide) double-blinded and randomized
Study population 51 healthy volunteers
Study site Prior to the study the pre-investigations will be performed at the University Hospital Salzburg, Austria. The high-altitude part will take place at the Capanna Regina Margherita (Margherita Hut, Italy) at 4559 m.
Interventions and investigations
- Ascend from Alagna (1130 m, Italy) to the Margherita Hut (4559 m) in less than 24 h, with a preceding overnight stay at 3611 m (Gnifetti Hut, Italy).
- Stay at
Sponsor: Salzburger Landeskliniken
Current Primary Outcome: Incidence of acute mountain sickness [ Time Frame: 48 hrs at 4559 m ]
AMS scores positive
Original Primary Outcome: Same as current
Current Secondary Outcome: Severity of acute mountain sickness [ Time Frame: 48 hrs at 4559 m ]
Height of AMS scores
Original Secondary Outcome: Same as current
Information By: Salzburger Landeskliniken
Dates:
Date Received: June 14, 2016
Date Started: June 2016
Date Completion:
Last Updated: October 13, 2016
Last Verified: October 2016