FeNO After Hypoxia in Asthma Patients

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StatusasBaigta

Rėmėjai

Medical University of Graz

Bendradarbiai

Ludwig Boltzmann Institute Lung Vascular Research

KLINIKINIS TYRIMAS: NCT02391090

BioSeek: nct02391090

Raktažodžiai

Santrauka

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.

Datos

Paskutinį kartą patikrinta:	02/28/2015
Pirmasis pateikimas:	01/25/2015
Numatytas registravimas pateiktas:	03/10/2015
Pirmas paskelbtas:	03/17/2015
Paskutinis atnaujinimas pateiktas:	03/10/2015
Paskutinis atnaujinimas paskelbtas:	03/17/2015
Faktinė studijų pradžios data:	10/31/2014
Numatoma pirminio užbaigimo data:	02/28/2015
Numatoma studijų užbaigimo data:	02/28/2015

Būklė ar liga

Asthma

Intervencija / gydymas

Device: hypoxia

Device: sham hypoxia

Procedure: Pulse oximetry

Other: Asthma and Quality of Life Questionnaires

Procedure: Lung function testing

Procedure: Blood taking

Procedure: FeNO measurement

Fazė

Rankų grupės

Ranka	Intervencija / gydymas
Experimental: 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	Device: hypoxia Intervention lasts 4 hours per day for 6 days in a row.
Sham Comparator: 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	Device: sham hypoxia Intervention lasts 4 hours per day for 6 days in a row.

Tinkamumo kriterijai

Amžius, tinkami studijuoti	18 Years Į 18 Years
Tinkamos studijoms lytys	All
Priima sveikus savanorius	Taip
Kriterijai	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

Rezultatas

Pirminės rezultatų priemonės

1. 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

Antrinės rezultatų priemonės

1. 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

2. 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

3. 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

4. Change in finger pulse oximetry [1 week]

Finger pulse oximetry will be measured hourly during the intervention for safety reasons.