Trial record 2 of 14 for:    expedition

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
  Purpose

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
Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Guidance of Patients With Asthma During Preparation and During Expedition to the Aconcagua Mountain

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Biospecimen Retention:   Samples With DNA

induced sputum cells and peripheral blood sample


Enrollment: 18
Study Start Date: January 2009
Study Completion Date: September 2012
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Asthma patients
all

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01760928

Locations
Belgium
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Study Director: Sven S Seys, MSc lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België
  More Information

No publications provided

Responsible Party: Dr. Lieven Dupont, Prof. dr., Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01760928     History of Changes
Other Study ID Numbers: ML9478
Study First Received: December 21, 2012
Last Updated: January 2, 2013
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014