FeNO After Hypoxia in Asthma Patients

March 11, 2015 updated by: Medical University of Graz

Effects of Intermittent Hypoxia on the Asthmatic Inflammation of Asthma Patients - a Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Styria
      • Graz, Styria, Austria, 8036
        • Medical University of Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 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.
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
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.
Device: sham hypoxia in hypoxic chamber
Intervention lasts 4 hours per day for 6 days in a row.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in forced exhaled nitric oxide after 6 days of hypoxia/sham
Time Frame: 1 week
Forced exhaled nitric oxide will be measured every day before and after the treatment
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in blood parameters after 6 days of hypoxia/sham
Time Frame: 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
1 week
Change in lung function parameters after 6 days of hypoxia/sham
Time Frame: 1 week
Lung function testing will be performed before the first and after the last intervention
1 week
Change in Quality of Life and Asthma questionnaires after 6 days of hypoxia/sham
Time Frame: 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
1 week
Change in finger pulse oximetry
Time Frame: 1 week
Finger pulse oximetry will be measured hourly during the intervention for safety reasons.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Collaborators

Ludwig Boltzmann Institute for Lung Vascular Research

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

January 26, 2015

First Submitted That Met QC Criteria

March 11, 2015

First Posted (Estimate)

March 18, 2015

Study Record Updates

Last Update Posted (Estimate)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 11, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUG-FeNO-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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