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

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.

Study Overview

• Status: Completed
• Conditions: Asthma

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 Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

asthmatics with well-controlled asthma

Description

Inclusion Criteria:

• asthma patient
• positive histamine provocation

Exclusion Criteria:

• exacerbation during the year prior to inclusion

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Asthma patients; all

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the type of airway inflammation evoked by exercise, hypoxia and cold air	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)	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To predict the occurrence of acute mountain sickness during an expedition to the Aconcagua mountain	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	one year

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Study Director: Sven S Seys, MSc, Lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: December 21, 2012
• First Submitted That Met QC Criteria: January 2, 2013
• First Posted (Estimate): January 4, 2013

Study Record Updates

• Last Update Posted (Estimate): January 4, 2013
• Last Update Submitted That Met QC Criteria: January 2, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: ML9478