EUCTR2016-000160-42-AT
Active, not recruiting
Phase 1
Effect of inhaled budenoside on the incidence and severity of Acute Mountain Sickness at 4559 m - Inhaled budenoside and AMS
K für Anästhesiologie und allgemeine Intensivmedizin0 sites51 target enrollmentMarch 22, 2016
ConditionsHealthy 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: 100000004863Therapeutic area: Body processes [G] - Physical Phenomena [G01]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Healthy volunteer trial at 4459m to investigate the effect of inhaled budenoside on the incidence and severity of Acute Mountain Sickness.
- Sponsor
- K für Anästhesiologie und allgemeine Intensivmedizin
- Enrollment
- 51
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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)
Outcomes
Primary Outcomes
Not specified
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