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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Lieven Dupont, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01760928
First received: December 21, 2012
Last updated: January 2, 2013
Last verified: January 2013

December 21, 2012
January 2, 2013
January 2009
January 2010   (final data collection date for primary outcome measure)
To assess the type of airway inflammation evoked by exercise, hypoxia and cold air [ Time Frame: one year ] [ Designated as safety issue: No ]
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)
Same as current
Complete list of historical versions of study NCT01760928 on ClinicalTrials.gov Archive Site
To predict the occurrence of acute mountain sickness during an expedition to the Aconcagua mountain [ Time Frame: one year ] [ Designated as safety issue: No ]
  • 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
Same as current
Not Provided
Not Provided
 
Guidance of Patients With Asthma During Preparation and During Expedition to the Aconcagua Mountain
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

induced sputum cells and peripheral blood sample

Non-Probability Sample

asthmatics with well-controlled asthma

Asthma
Not Provided
Asthma patients
all
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
September 2012
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • asthma patient
  • positive histamine provocation

Exclusion Criteria:

  • exacerbation during the year prior to inclusion
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01760928
ML9478
No
Dr. Lieven Dupont, Universitaire Ziekenhuizen Leuven
Universitaire Ziekenhuizen Leuven
Not Provided
Study Director: Sven S Seys, MSc lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België
Universitaire Ziekenhuizen Leuven
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP