Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
21 participants
INTERVENTIONAL
2014-11-30
2015-03-31
Brief Summary
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Effects of this intermittent hypoxia on the asthmatic inflammation of these patients will be measured. The primary endpoint is the change in forced exhaled nitric oxide (FeNO) before and after the study. Secondary endpoints include blood parameters, lung function testing and questionnaires.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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hypoxia
The hypoxia group receives normobaric hypoxic air while sitting in a hypoxic chamber simulating 2800 meter above sea level.
Interventions: hypoxia in hypoxic chamber, asthma and Quality of Life Questionnaires, lung function testing, blood taking, FeNO measurement, pulse oximetry
hypoxia in hypoxic chamber
Intervention lasts 4 hours per day for 6 days in a row.
Pulse oximetry
Pulse oximetry will be performed hourly during sessions in the hypoxic chamber for safety reasons.
Asthma and Quality of Life Questionnaires
Before every session in the hypoxic chamber as well as on the day after the last session will be completed.
Lung function testing
On the day of the first session in the hypoxic chamber as well as on the day after the last session lung function testing will be performed.
Blood taking
On the day of the first session in the hypoxic chamber as well as on the day after the last session blood samples will be taken.
FeNO measurement
Before every session in the hypoxic chamber as well as on the day after the last session FeNO (forced exhaled nitric oxide) measurement will be performed.
sham hypoxia
The sham group receives normal air while sitting in a hypoxic chamber in about 360 meter above sea level (Graz, Austria).
Interventions: sham hypoxia in hypoxic chamber, asthma and Quality of Life Questionnaires, lung function testing, blood taking, FeNO measurement, pulse oximetry
sham hypoxia in hypoxic chamber
Intervention lasts 4 hours per day for 6 days in a row.
Pulse oximetry
Pulse oximetry will be performed hourly during sessions in the hypoxic chamber for safety reasons.
Asthma and Quality of Life Questionnaires
Before every session in the hypoxic chamber as well as on the day after the last session will be completed.
Lung function testing
On the day of the first session in the hypoxic chamber as well as on the day after the last session lung function testing will be performed.
Blood taking
On the day of the first session in the hypoxic chamber as well as on the day after the last session blood samples will be taken.
FeNO measurement
Before every session in the hypoxic chamber as well as on the day after the last session FeNO (forced exhaled nitric oxide) measurement will be performed.
Interventions
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hypoxia in hypoxic chamber
Intervention lasts 4 hours per day for 6 days in a row.
sham hypoxia in hypoxic chamber
Intervention lasts 4 hours per day for 6 days in a row.
Pulse oximetry
Pulse oximetry will be performed hourly during sessions in the hypoxic chamber for safety reasons.
Asthma and Quality of Life Questionnaires
Before every session in the hypoxic chamber as well as on the day after the last session will be completed.
Lung function testing
On the day of the first session in the hypoxic chamber as well as on the day after the last session lung function testing will be performed.
Blood taking
On the day of the first session in the hypoxic chamber as well as on the day after the last session blood samples will be taken.
FeNO measurement
Before every session in the hypoxic chamber as well as on the day after the last session FeNO (forced exhaled nitric oxide) measurement will be performed.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* unstable Asthma (GINA 3-4)
* history of pneumonia/fever within 3 months
* place of residence \>1000m above sea level
* trip/vacation above \>2500m within 4 weeks
* cystic fibrosis
* diabetes mellitus
* immunodeficiency
* atopic dermatitis
* ciliary dyskinesia
* pregnancy
* chronic obstructive pulmonary disease
* history of smoking (\>1py)
* immunosuppression / systemic corticosteroids within 3 months
* cardiovascular diseases
* interstitial lung disease
* bronchopulmonary dysplasia
18 Years
ALL
No
Sponsors
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Ludwig Boltzmann Institute for Lung Vascular Research
OTHER
Medical University of Graz
OTHER
Responsible Party
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Principal Investigators
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Horst Olschewski, MD, Prof.
Role: PRINCIPAL_INVESTIGATOR
Medical University of Graz, Department of Internal Medicine, Division of Pulmonology
Locations
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Medical University of Graz
Graz, Styria, Austria
Countries
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Other Identifiers
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MUG-FeNO-2013
Identifier Type: -
Identifier Source: org_study_id
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