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Inhaled Budesonide and Acute Mountain Sickness

Primary Purpose

Acute Mountain Sickness

Status
Completed
Phase
Phase 1
Locations
Austria
Study Type
Interventional
Intervention
Budesonide 200
Budesonide 800
Placebo
Sponsored by
Salzburger Landeskliniken
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Mountain Sickness focused on measuring High Altitude, budesonide, hypoxia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

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)
  • 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

Sites / Locations

  • Department of Anesthesiology, University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

budesonide 200

budesonide 800

placebo

Arm Description

inhaled budesonide 200 µg bid

inhaled budesonide 800 µg bid

inhaled placebo bid

Outcomes

Primary Outcome Measures

Incidence of acute mountain sickness
AMS scores positive

Secondary Outcome Measures

Severity of acute mountain sickness
Height of AMS scores

Full Information

First Posted
June 14, 2016
Last Updated
October 13, 2016
Sponsor
Salzburger Landeskliniken
Collaborators
University Hospital Heidelberg
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1. Study Identification

Unique Protocol Identification Number
NCT02811016
Brief Title
Inhaled Budesonide and Acute Mountain Sickness
Official Title
Effect of Inhaled Budesonide on the Incidence and Severity of Acute Mountain Sickness at 4559 m
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Salzburger Landeskliniken
Collaborators
University Hospital Heidelberg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: Does inhaled budesonide reduce the severity of AMS after rapid and active ascent to 4559 m? 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
Detailed Description
Primary objective 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: Does inhaled budesonide reduce the severity of AMS after rapid and active ascent to 4559 m? 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 budensoide) double-blinded and randomized Study population 51 healthy volunteers Study site Prior to the study the pre-investigations will be performed at the University Hospital Salzburg, Austria. The high-altitude part will take place at the Capanna Regina Margherita (Margherita Hut, Italy) at 4559 m. Interventions and investigations Ascend from Alagna (1130 m, Italy) to the Margherita Hut (4559 m) in less than 24 h, with a preceding overnight stay at 3611 m (Gnifetti Hut, Italy). Stay at the Margherita Hut for 48 hours Randomized inhalation of budesonide at two different concentrations (2 x 200 µg 2 x 800 µg, respectively) or placebo Assessment of incidence and severity of acute mountain sickness by use of 2 internationally standardized and well established questionnaires Venous (and capillary) blood drawings Pulmonary function tests Transthoracic echocardiography for assessing pulmonary artery systolic pressure Number and volume of blood drawings For the study venous blood samples (volume: 20 ml each) will be drawn at 5 different time points (5 x 20 ml = 100 ml). Together with the blood drawing for the pre-investigation (20 ml) a total blood volume of 120 ml will be taken. At the same time points capillary blood samples (1 ml) will be taken from the ear lobe for blood gas analyses (5 x 1 ml = 5 ml in total). Observational period The study will only start after approval by the ethic committee responsible for the study (ethic committee of the Paracelsus Medical University). If the study is approved it will be performed in July 2016.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Mountain Sickness
Keywords
High Altitude, budesonide, hypoxia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
budesonide 200
Arm Type
Experimental
Arm Description
inhaled budesonide 200 µg bid
Arm Title
budesonide 800
Arm Type
Experimental
Arm Description
inhaled budesonide 800 µg bid
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
inhaled placebo bid
Intervention Type
Drug
Intervention Name(s)
Budesonide 200
Other Intervention Name(s)
Pulmicort Turbohaler
Intervention Description
200 µg inhaled at 7:00 a.m. and 7 p.m.
Intervention Type
Drug
Intervention Name(s)
Budesonide 800
Other Intervention Name(s)
Pulmicort Turbohaler
Intervention Description
800 µg inhaled at 7:00 a.m. and 7 p.m.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Lactose-Monohydrate
Intervention Description
Placebo Inhalation at 7:00 a.m. and 7 p.m.
Primary Outcome Measure Information:
Title
Incidence of acute mountain sickness
Description
AMS scores positive
Time Frame
48 hrs at 4559 m
Secondary Outcome Measure Information:
Title
Severity of acute mountain sickness
Description
Height of AMS scores
Time Frame
48 hrs at 4559 m

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 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) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc M Berger, MD
Organizational Affiliation
Department of Anesthesiology, University Hospital Salzburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology, University Hospital
City
Salzburg
ZIP/Postal Code
5020
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28890439
Citation
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.
Results Reference
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Inhaled Budesonide and Acute Mountain Sickness

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