Guidance of Patients With Asthma During Preparation and During Expedition to the Aconcagua Mountain

Completed

• Conditions: Asthma

• Registration Number: NCT01760928
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

A selection of asthma patients were followed during preparation to climb the Aconcagua mountain. The primary goal of this follow up was to optimize patients' asthma status. Also during expedition, these patients were daily consulted by a physician. All data obtained during preparation and expedition will now be retrospectively analyzed.

Detailed Description

Preparation phase:

Eighteen asthma patients were selected based on physical and medical characteristics. During the year of preparation, several time points of evaluation were planned: evaluation at baseline, maximal exercise test in hypoxia (FiO2: 11%), 24hour stay at cold air environment.

At baseline, medical history was evaluated and clinical examination, ECG, lung function, Fraction of exhaled NO measurement and histamine provocation were performed.

During a second visit, patients stayed for approximately one hour in a chamber to simulate high altitude (FiO2:11%) and performed a maximal exercise test after 30 minutes of rest. Oxygen saturation, ECG and oxygen consumption were continuously monitored. Lung function and fraction of exhaled NO were assessed before and after the test. Also, peripheral blood was drawn before and after the test. This test allowed us to identify whether patients may develop acute mountain sickness later on during expedition.

During a third visit, patients stayed for 24 hours in a indoor ski centre to practice climbing techniques, building up a tent and working with the specialized materials. Temperature at the ski piste varies between -5°C and -10°C. Lung function, fraction of exhaled NO and induced sputum was assessed before and after the stay at the ski centre.

During the expedition, clinical status, heart rate and oxygen saturation were measured daily. Also, lung function and fraction of exhaled NO were regularly measured. A screening for acute mountain sickness was performed daily. Asthmatics patients were supported by two pulmonologist. Before and after expedition, spirometry, histamine provocation and induced sputum were performed.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2010-01
• Study Completion: 2012-09
• Study First Submitted: 2012-12-21
• Status Verified: 2013-01
• Study First Submitted QC: 2013-01-02
• Last Update Submitted: 2013-01-02
• Study First Posted: 2013-01-04
• Last Update Posted: 2013-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• asthma patient
• positive histamine provocation

Exclusion Criteria

• exacerbation during the year prior to inclusion

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the type of airway inflammation evoked by exercise, hypoxia and cold air	one year	Sputum cells and cytokine messenger ribonucleic acid will be analyzed to determine the type of airway inflammation that is induced by several triggers (exercise, hypoxia and cold air)

Secondary Outcome Measures

Name	Time	Method
To predict the occurrence of acute mountain sickness during an expedition to the Aconcagua mountain	one year	* Mean Lake Louise Score in subjects; * Number of subjects with Lake Louise Score \> 5; * Mean change in daily asthma symptom score; * Mean change in Asthma control test score; * Number of participants with an acute asthma exacerbation

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium