FeNO After Hypoxia in Asthma Patients

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DurumTamamlandı

Sponsorlar

Medical University of Graz

Ortak çalışanlar

Ludwig Boltzmann Institute Lung Vascular Research

KLINIK ÇALIŞMA: NCT02391090

BioSeek: nct02391090

Anahtar kelimeler

Öz

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.

Tarih

Son Doğrulandı:	02/28/2015
İlk Gönderilen:	01/25/2015
Tahmini Kayıt Gönderildi:	03/10/2015
İlk Gönderilen:	03/17/2015
Son Güncelleme Gönderildi:	03/10/2015
Son Güncelleme Gönderildi:	03/17/2015
Fiili Çalışma Başlangıç Tarihi:	10/31/2014
Tahmini Birincil Tamamlanma Tarihi:	02/28/2015
Tahmini Çalışma Tamamlanma Tarihi:	02/28/2015

Durum veya hastalık

Asthma

Müdahale / tedavi

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

Evre

Kol Grupları

Kol	Müdahale / tedavi
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.

Uygunluk kriterleri

Çalışmaya Uygun Yaşlar	18 Years İçin 18 Years
Çalışmaya Uygun Cinsiyetler	All
Sağlıklı Gönüllüleri Kabul Ediyor	Evet
Kriterler	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

Sonuç

Birincil Sonuç Ölçütleri

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

İkincil Sonuç Ölçütleri

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.

FeNO After Hypoxia in Asthma Patients

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