FeNO After Hypoxia in Asthma Patients

NCT02391090 | Completed DMC

• 1 other identifier: MUG-FeNO-2013
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

asthma; hypoxia; forced exhaled nitric oxide; inflammation

Outcome Measures

Primary Outcomes (1)

• Change in forced exhaled nitric oxide after 6 days of hypoxia/sham

  Forced exhaled nitric oxide will be measured every day before and after the treatment

  1 week

Secondary Outcomes (4)

• Change in blood parameters after 6 days of hypoxia/sham

  1 week

• Change in lung function parameters after 6 days of hypoxia/sham

  1 week

• Change in Quality of Life and Asthma questionnaires after 6 days of hypoxia/sham

  1 week

• Change in finger pulse oximetry

  1 week

Study Arms (2)

hypoxia

EXPERIMENTAL

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; Procedure: Pulse oximetry; Other: Asthma and Quality of Life Questionnaires; Procedure: Lung function testing; Procedure: Blood taking; Procedure: FeNO measurement

sham hypoxia

SHAM COMPARATOR

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 in hypoxic chamber; Procedure: Pulse oximetry; Other: Asthma and Quality of Life Questionnaires; Procedure: Lung function testing; Procedure: Blood taking; Procedure: FeNO measurement

Interventions

hypoxia in hypoxic chamber DEVICE

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

hypoxia

sham hypoxia in hypoxic chamber DEVICE

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

sham hypoxia

Pulse oximetry PROCEDURE

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

hypoxia; sham hypoxia

Asthma and Quality of Life Questionnaires OTHER

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

hypoxia; sham hypoxia

Lung function testing 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.

hypoxia; sham hypoxia

Blood taking 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.

hypoxia; sham hypoxia

FeNO measurement 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.

hypoxia; sham hypoxia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• stable Asthma (GINA 1-2)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead
• Ludwig Boltzmann Institute for Lung Vascular Research: collaborator

Study Sites (1)

Medical University of Graz

Graz, Styria, 8036, Austria

Location

MeSH Terms

Conditions

Asthma; Hypoxia; Inflammation

Interventions

Oximetry

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Blood Gas Analysis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Study Officials

• Horst Olschewski, MD, Prof.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2015
• First Posted: March 18, 2015
• Study Start: November 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 18, 2015

Record last verified: 2015-03

Locations

AU (1)