NCT02811016

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:

  • 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 23, 2016

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 14, 2016

Status Verified

October 1, 2016

Enrollment Period

1 month

First QC Date

June 14, 2016

Last Update Submit

October 13, 2016

Conditions

Acute Mountain Sickness

Keywords

High Altitudebudesonidehypoxia

Outcome Measures

Primary Outcomes (1)

  • Incidence of acute mountain sickness

    AMS scores positive

    48 hrs at 4559 m

Secondary Outcomes (1)

  • Severity of acute mountain sickness

    48 hrs at 4559 m

Study Arms (3)

budesonide 200

EXPERIMENTAL

inhaled budesonide 200 µg bid

Drug: Budesonide 200

budesonide 800

EXPERIMENTAL

inhaled budesonide 800 µg bid

Drug: Budesonide 800

placebo

PLACEBO COMPARATOR

inhaled placebo bid

Drug: Placebo

Interventions

Budesonide 200DRUG

200 µg inhaled at 7:00 a.m. and 7 p.m.

Also known as: Pulmicort Turbohaler
budesonide 200
Budesonide 800DRUG

800 µg inhaled at 7:00 a.m. and 7 p.m.

Also known as: Pulmicort Turbohaler
budesonide 800
PlaceboDRUG

Placebo Inhalation at 7:00 a.m. and 7 p.m.

Also known as: Lactose-Monohydrate
placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, University Hospital

Salzburg, Salzburg, 5020, Austria

Location

Related Publications (1)

  • Berger MM, Macholz F, Sareban M, Schmidt P, Fried S, Dankl D, Niebauer J, Bartsch P, Mairbaurl H. Inhaled budesonide does not prevent acute mountain sickness after rapid ascent to 4559 m. Eur Respir J. 2017 Sep 10;50(3):1700982. doi: 10.1183/13993003.00982-2017. Print 2017 Sep. No abstract available.

    PMID: 28890439DERIVED

MeSH Terms

Conditions

Altitude SicknessHypoxia

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marc M Berger, MD

    Department of Anesthesiology, University Hospital Salzburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med.

Study Record Dates

First Submitted

June 14, 2016

First Posted

June 23, 2016

Study Start

June 1, 2016

Primary Completion

July 1, 2016

Study Completion

October 1, 2016

Last Updated

October 14, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)