Asthma
Conditions
Keywords
asthma, hypoxia, forced exhaled nitric oxide, inflammation
Brief summary
Stable Asthma patients (GINA 1-2) stay 6 days in a row for 4 hours per day in a hypoxic chamber simulating 2800m above sea level. Study participants will be blinded to the treatment given and divided into a hypoxic and a sham group (about 360m above sea level). 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.
Interventions
DEVICEhypoxia in hypoxic chamber
Intervention lasts 4 hours per day for 6 days in a row.
DEVICEsham hypoxia in hypoxic chamber
Intervention lasts 4 hours per day for 6 days in a row.
PROCEDUREPulse oximetry
Pulse oximetry will be performed hourly during sessions in the hypoxic chamber for safety reasons.
OTHERAsthma 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.
PROCEDURELung 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.
PROCEDUREBlood 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.
PROCEDUREFeNO 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.
Sponsors
Ludwig Boltzmann Institute for Lung Vascular Research
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* stable Asthma (GINA 1-2)
Exclusion criteria
* autoimmune disease * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in forced exhaled nitric oxide after 6 days of hypoxia/sham | 1 week | Forced exhaled nitric oxide will be measured every day before and after the treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in blood parameters after 6 days of hypoxia/sham | 1 week | Blood parameters including c-reactive protein, complete blood cell count, total immunoglobulin e (IgE), specific IgE of seasonal inhalative antigens and eosinophilic cationic protein will be measured. Blood samples will be taken before the first and after the last intervention |
| Change in lung function parameters after 6 days of hypoxia/sham | 1 week | Lung function testing will be performed before the first and after the last intervention |
| Change in Quality of Life and Asthma questionnaires after 6 days of hypoxia/sham | 1 week | Questionnaires include Asthma Control Test, Asthma Quality of Life Questionnaire, Asthma Control Questionnaire, a quality of life questionnaire and the Asthma Control Diary. Documents will be collected every day before the intervention |
| Change in finger pulse oximetry | 1 week | Finger pulse oximetry will be measured hourly during the intervention for safety reasons. |
Countries
Austria
Outcome results
None listed