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Inhaled Budesonide and Acute Mountain Sickness

NCT02811016 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2016-10-14

No results posted yet for this study

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

Conditions

  • Acute Mountain Sickness

Interventions

DRUG

Budesonide 200

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

DRUG

Budesonide 800

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

DRUG

Placebo

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

Sponsors & Collaborators

  • University Hospital Heidelberg

    collaborator OTHER

  • Salzburger Landeskliniken

    lead OTHER

Principal Investigators

  • Marc M Berger, MD · Department of Anesthesiology, University Hospital Salzburg

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2016-07-31
Completion
2016-10-31

Countries

  • Austria

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02811016 on ClinicalTrials.gov