FeNO After Hypoxia in Asthma Patients

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Intermittent Hypoxia on the Asthmatic Inflammation of Asthma Patients - a Pilot Study

Conditions
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Asthma

Intervention / Treatment
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* Device: hypoxia in hypoxic chamber
* Device: sham hypoxia in hypoxic chamber
* Procedure: Pulse oximetry
* Other: Asthma and Quality of Life Questionnaires
* Procedure: Lung function testing
* Procedure: Blood taking
* Procedure: FeNO measurement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hypoxia<br>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 | Device: hypoxia in hypoxic chamber<br>* Intervention lasts 4 hours per day for 6 days in a row.<br>Procedure: Pulse oximetry<br>* Pulse oximetry will be performed hourly during sessions in the hypoxic chamber for safety reasons.<br>Other: Asthma and Quality of Life Questionnaires<br>* Before every session in the hypoxic chamber as well as on the day after the last session will be completed.<br>Procedure: Lung function testing<br>* 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.<br>Procedure: Blood taking<br>* 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.<br>Procedure: FeNO measurement<br>* 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.<br>|
| Sham Comparator: sham hypoxia<br>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 | Device: sham hypoxia in hypoxic chamber<br>* Intervention lasts 4 hours per day for 6 days in a row.<br>Procedure: Pulse oximetry<br>* Pulse oximetry will be performed hourly during sessions in the hypoxic chamber for safety reasons.<br>Other: Asthma and Quality of Life Questionnaires<br>* Before every session in the hypoxic chamber as well as on the day after the last session will be completed.<br>Procedure: Lung function testing<br>* 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.<br>Procedure: Blood taking<br>* 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.<br>Procedure: FeNO measurement<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, hypoxia, forced exhaled nitric oxide, inflammation