FeNO After Hypoxia in Asthma Patients

Medical University of Graz

Status: Completed

Conditions: Asthma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02391090

MUG-FeNO-2013

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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21 participants in 2 patient groups

hypoxia

Experimental group

Description:

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

Treatment:

Device: hypoxia in hypoxic chamber

Procedure: Pulse oximetry

Other: Asthma and Quality of Life Questionnaires

Procedure: Lung function testing

Procedure: Blood taking

Procedure: FeNO measurement

sham hypoxia

Sham Comparator group

Description:

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

Treatment:

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