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

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:

  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 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