Inhaled Budesonide and Acute Mountain Sickness

Acute Mountain Sickness Clinical Trial

Official title:

Effect of Inhaled Budesonide on the Incidence and Severity of Acute Mountain Sickness at 4559 m

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02811016
• Other study ID #: M2016
• Status: Completed
• Phase: Phase 1
• First received: June 14, 2016
• Last updated: October 13, 2016
• Start date: June 2016
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Salzburger Landeskliniken
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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

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:

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: October 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Mountain Sickness
• Altitude Sickness

Intervention

Drug:
• Budesonide 200
200 µg inhaled at 7:00 a.m. and 7 p.m.
• Budesonide 800
800 µg inhaled at 7:00 a.m. and 7 p.m.
• Placebo
Placebo Inhalation at 7:00 a.m. and 7 p.m.

Locations

Country	Name	City	State
Austria	Department of Anesthesiology, University Hospital	Salzburg

Sponsors (2)

Lead Sponsor	Collaborator
Salzburger Landeskliniken	University Hospital Heidelberg

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of acute mountain sickness	AMS scores positive	48 hrs at 4559 m	No
Secondary	Severity of acute mountain sickness	Height of AMS scores	48 hrs at 4559 m	No