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| Name | Class |
|---|---|
| Ludwig Boltzmann Institute for Lung Vascular Research | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hypoxia | Experimental | 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 |
|
| sham hypoxia | Sham Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hypoxia in hypoxic chamber | Device | Intervention lasts 4 hours per day for 6 days in a row. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in forced exhaled nitric oxide after 6 days of hypoxia/sham | Forced exhaled nitric oxide will be measured every day before and after the treatment | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood parameters after 6 days of hypoxia/sham | 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 | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Horst Olschewski, MD, Prof. | Medical University of Graz, Department of Internal Medicine, Division of Pulmonology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz | Graz | Styria | 8036 | Austria |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D000860 | Hypoxia |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D010092 | Oximetry |
| ID | Term |
|---|---|
| D001784 | Blood Gas Analysis |
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
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| sham hypoxia in hypoxic chamber |
| Device |
Intervention lasts 4 hours per day for 6 days in a row. |
|
| Pulse oximetry | Procedure | Pulse oximetry will be performed hourly during sessions in the hypoxic chamber for safety reasons. |
|
| Asthma and Quality of Life Questionnaires | Other | Before every session in the hypoxic chamber as well as on the day after the last session will be completed. |
|
| Lung function testing | Procedure | 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 | Procedure | 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 | Procedure | 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. |
|
| Change in lung function parameters after 6 days of hypoxia/sham |
Lung function testing will be performed before the first and after the last intervention |
| 1 week |
| Change in Quality of Life and Asthma questionnaires after 6 days of hypoxia/sham | 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 | 1 week |
| Change in finger pulse oximetry | Finger pulse oximetry will be measured hourly during the intervention for safety reasons. | 1 week |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D008919 | Investigative Techniques |