Inhaled Budesonide and Acute Mountain Sickness

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Brief Title

Inhaled Budesonide and Acute Mountain Sickness

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 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.

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Incidence of acute mountain sickness

Secondary Outcome

 Severity of acute mountain sickness

Condition

Acute Mountain Sickness

Intervention

Budesonide 200

Study Arms / Comparison Groups

 budesonide 200
Description:  inhaled budesonide 200 µg bid

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

51

Start Date

June 2016

Completion Date

October 2016

Primary Completion Date

July 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Good physical condition

          -  No relevant pathologies revealed by the pre-investigation prior to the study

          -  Written informed consent to participate in the study

          -  Permanent residency below 1000 m

          -  Males and females are included without prioritization

        Exclusion Criteria:

          -  Acute and chronic lung diseases

          -  Conventional systolic blood pressure (average of two measurements) ≥150 mmHg and
             conventional diastolic blood pressure ≥95 mmHg in untreated or treated subjects

          -  Cardiovascular diseases other than hypertension (coronary heart disease, heart
             failure, atrial fibrillation, peripheral artery disease)

          -  Chronic headache / migraine

          -  Diabetes mellitus

          -  Smoking (>6 cigarettes/day) or equivalent nicotine substitutes

          -  Alcohol (>30 g/d) or drug abuse

          -  Obesity (Body Mass Index >30)

          -  Other conditions deemed relevant by the investigator (including liver disease, renal
             disease)

          -  Sojourn >2000 m within the last 4 weeks before the 1st study day

          -  Drug intake within the last 2 moth before the 1st study day if the drug intake could
             affect the data quality or the safety of the participants

          -  Blood donation within the last 2 month before the 1st study day

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Marc M Berger, MD, ,

Location Countries

Austria

Location Countries

Austria

Administrative Informations

NCT ID

NCT02811016

Organization ID

M2016

Responsible Party

Principal Investigator

Study Sponsor

Salzburger Landeskliniken

Collaborators

 University Hospital Heidelberg

Study Sponsor

Marc M Berger, MD, Principal Investigator, Department of Anesthesiology, University Hospital Salzburg

Verification Date

October 2016