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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

Tracking Information
First Submitted Date December 21, 2012
First Posted Date January 4, 2013
Last Update Posted Date January 4, 2013
Study Start Date January 2009
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 2, 2013)
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)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 2, 2013)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Guidance of Patients With Asthma During Preparation and During Expedition to the Aconcagua Mountain
Official Title Guidance of Patients With Asthma During Preparation and During Expedition to the Aconcagua Mountain
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
induced sputum cells and peripheral blood sample
Sampling Method Non-Probability Sample
Study Population asthmatics with well-controlled asthma
Condition Asthma
Intervention Not Provided
Study Groups/Cohorts Asthma patients
all
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 2, 2013)
18
Original Actual Enrollment Same as current
Actual Study Completion Date September 2012
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • asthma patient
  • positive histamine provocation

Exclusion Criteria:

  • exacerbation during the year prior to inclusion
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT01760928
Other Study ID Numbers ML9478
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. Lieven Dupont, Universitaire Ziekenhuizen Leuven
Study Sponsor Universitaire Ziekenhuizen Leuven
Collaborators Not Provided
Investigators
Study Director: Sven S Seys, MSc lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België
PRS Account Universitaire Ziekenhuizen Leuven
Verification Date January 2013