Inhaled Budesonide and Acute Mountain Sickness

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Salzburger Landeskliniken
• Collaborator: University Hospital Heidelberg
• Treatments: Budesonide

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