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

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ClinicalTrials.gov Identifier: NCT01760928
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : January 4, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. Lieven Dupont, Universitaire Ziekenhuizen Leuven

Study Description
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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.

Condition or disease
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 Design
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Study Type : Observational
Actual Enrollment : 18 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Guidance of Patients With Asthma During Preparation and During Expedition to the Aconcagua Mountain
Study Start Date : January 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Groups and Cohorts
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Group/Cohort
Asthma patients
all


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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
induced sputum cells and peripheral blood sample

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
asthmatics with well-controlled asthma
Criteria

Inclusion Criteria:

  • asthma patient
  • positive histamine provocation

Exclusion Criteria:

  • exacerbation during the year prior to inclusion
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760928


Locations
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Belgium
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Study Director: Sven S Seys, MSc lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België
More Information
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Responsible Party: Dr. Lieven Dupont, Prof. dr., Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01760928    
Other Study ID Numbers: ML9478
First Posted: January 4, 2013    Key Record Dates
Last Update Posted: January 4, 2013
Last Verified: January 2013
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases