FeNO After Hypoxia in Asthma Patients

Summary

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.

Conditions

• Asthma

Interventions

DEVICE

hypoxia in hypoxic chamber

Intervention lasts 4 hours per day for 6 days in a row.

DEVICE

sham hypoxia in hypoxic chamber

Intervention lasts 4 hours per day for 6 days in a row.

PROCEDURE

Pulse oximetry

Pulse oximetry will be performed hourly during sessions in the hypoxic chamber for safety reasons.

OTHER

Asthma and Quality of Life Questionnaires

Before every session in the hypoxic chamber as well as on the day after the last session will be completed.

PROCEDURE

Lung function testing

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.

PROCEDURE

Blood taking

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.

PROCEDURE

FeNO measurement

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.

Sponsors & Collaborators

• Ludwig Boltzmann Institute for Lung Vascular Research

  collaborator OTHER

• Medical University of Graz

  lead OTHER

Principal Investigators

• Horst Olschewski, MD, Prof. · Medical University of Graz, Department of Internal Medicine, Division of Pulmonology

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-11-30

Primary Completion

2015-03-31

Completion

2015-03-31

Countries

• Austria

Study Locations