Guidance of Patients With Asthma During Preparation and During Expedition to the Aconcagua Mountain
|ClinicalTrials.gov Identifier: NCT01760928|
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : January 4, 2013
|Condition or disease|
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|
|Actual Enrollment :||18 participants|
|Official Title:||Guidance of Patients With Asthma During Preparation and During Expedition to the Aconcagua Mountain|
|Study Start Date :||January 2009|
|Primary Completion Date :||January 2010|
|Study Completion Date :||September 2012|
- To assess the type of airway inflammation evoked by exercise, hypoxia and cold air [ Time Frame: 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)
- To predict the occurrence of acute mountain sickness during an expedition to the Aconcagua mountain [ Time Frame: 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
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760928
|Leuven, Vlaams-Brabant, Belgium, 3000|
|Study Director:||Sven S Seys, MSc||lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België|