FeNO After Hypoxia in Asthma Patients

NCT ID: NCT02391090

Last Updated: 2015-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-03-31

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.

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type EXPERIMENTAL

hypoxia in hypoxic chamber

Intervention Type DEVICE

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

Pulse oximetry

Intervention Type PROCEDURE

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

Asthma and Quality of Life Questionnaires

Intervention Type OTHER

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

Lung function testing

Intervention Type PROCEDURE

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.

Blood taking

Intervention Type PROCEDURE

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.

FeNO measurement

Intervention Type PROCEDURE

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.

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

Group Type SHAM_COMPARATOR

sham hypoxia in hypoxic chamber

Intervention Type DEVICE

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

Pulse oximetry

Intervention Type PROCEDURE

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

Asthma and Quality of Life Questionnaires

Intervention Type OTHER

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

Lung function testing

Intervention Type PROCEDURE

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.

Blood taking

Intervention Type PROCEDURE

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.

FeNO measurement

Intervention Type PROCEDURE

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.

Interventions

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hypoxia in hypoxic chamber

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

Intervention Type DEVICE

sham hypoxia in hypoxic chamber

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

Intervention Type DEVICE

Pulse oximetry

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

Intervention Type PROCEDURE

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.

Intervention Type OTHER

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ludwig Boltzmann Institute for Lung Vascular Research

OTHER

Sponsor Role collaborator

Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Horst Olschewski, MD, Prof.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz, Department of Internal Medicine, Division of Pulmonology

Locations

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Medical University of Graz

Graz, Styria, Austria

Site Status

Countries

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Austria

Other Identifiers

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MUG-FeNO-2013

Identifier Type: -

Identifier Source: org_study_id

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