Effect of a inhaled corticoid on the Acute Mountain Sickness at 4559m

Phase 1

Conditions: Healthy volunteer trial at 4459m to investigate the effect of inhaled budenoside on the incidence and severity of Acute Mountain Sickness.
MedDRA version: 19.0Level: LLTClassification code 10020045Term: High altitude illnessSystem Organ Class: 100000004863
Therapeutic area: Body processes [G] - Physical Phenomena [G01]

Registration Number: EUCTR2016-000160-42-AT

Lead Sponsor: K für Anästhesiologie und allgemeine Intensivmedizin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 51

Inclusion Criteria

-Age 18-60 years
-Good physical condition
-No relevant pathologies upon the pre-examination prior to the study
-Written informed consent to participate in the study
-Males and females are included without prioritization
-Permanent residency below 1000 m
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 51
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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, thyroid disorders)
-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 (eg. corticosteroids) or the safety of the participants (eg. anti- coagulants)
-Blood donation within the last 2 month before the 1st study day

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Does inhaled budenoside reduce the incidence of AMS after rapid and active ascent to 4559 m?;Secondary Objective: 1.Does inhaled budenoside reduce the severity of AMS after rapid and active ascent to 4559 m?<br>2.Are the effects of inhaled budenoside on AMS incidence and severity related to its plasma concentration?;Primary end point(s): Incidence of Acute Mountain Sickness;Timepoint(s) of evaluation of this end point: After 48 h at 4559 m

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Severity of Acute Mountain Sickness<br>2. Relationship between severity of Acute Mountain Sickness and budenoside plasma levels;Timepoint(s) of evaluation of this end point: After 48 h at 4559 m