Inhaled Budesonide and Acute Mountain Sickness
Condition: Acute Mountain Sickness
MeSH terms: Altitude Sickness
Study type: Interventional
Phase: Phase 1

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 description: 
      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 the Margherita Hut for 48 hours

        -  Randomized inhalation of budesonide at two different concentrations (2 x 200 µg 2 x 800
           µg, respectively) or placebo

        -  Assessment of incidence and severity of acute mountain sickness by use of 2
           internationally standardized and well established questionnaires

        -  Venous (and capillary) blood drawings

        -  Pulmonary function tests

        -  Transthoracic echocardiography for assessing pulmonary artery systolic pressure

      Number and volume of blood drawings For the study venous blood samples (volume: 20 ml each)
      will be drawn at 5 different time points (5 x 20 ml = 100 ml). Together with the blood
      drawing for the pre-investigation (20 ml) a total blood volume of 120 ml will be taken. At
      the same time points capillary blood samples (1 ml) will be taken from the ear lobe for blood
      gas analyses (5 x 1 ml = 5 ml in total).

      Observational period The study will only start after approval by the ethic committee
      responsible for the study (ethic committee of the Paracelsus Medical University). If the
      study is approved it will be performed in July 2016.
    

Intervention name(s): Budesonide 200; Budesonide 800; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 200 µg inhaled at 7:00 a.m. and 7 p.m.; 800 µg inhaled at 7:00 a.m. and 7 p.m.; Placebo Inhalation at 7:00 a.m. and 7 p.m.
Other intervention name(s): Pulmicort Turbohaler; Pulmicort Turbohaler; Lactose-Monohydrate
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: High Altitude; budesonide; hypoxia