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

Effect of inhaled budenoside on the incidence and severity of Acute Mountain Sickness at 4559 m - Inhaled budenoside and AMS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000160-42-AT

Enrollment

Registered

2016-03-22

Start date

2016-05-17

Completion date

Unknown

Last updated

2016-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteer trial at 4459m to investigate the effect of inhaled budenoside on the incidence and severity of Acute Mountain Sickness. MedDRA version: 19.0 Level: LLT Classification code 10020045 Term: High altitude illness System Organ Class: 100000004863

Interventions

Trade Name: Budenoside 0,1 Product Name: Budesonid 0,1mg Pharmaceutical Form: Inhalation powder INN or Proposed INN: BUDESONIDE CAS Number: 51333-22-3 Pharmaceutical form of the placebo: Inhalation po

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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? 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	—

Measure

Time frame

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? 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

Measure	Time frame
Secondary end point(s): 1. Severity of Acute Mountain Sickness 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	—

Countries

Austria

Contacts

Public ContactSekretariat

UK für Anästhesiologie und allgemeine Intensivmedizin

ma.berger@salk.at00435725524001

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026