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FeNO After Hypoxia in Asthma Patients

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
hypoxia in hypoxic chamber
sham hypoxia in hypoxic chamber
Pulse oximetry
Asthma and Quality of Life Questionnaires
Lung function testing
Blood taking
FeNO measurement
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Asthma focused on measuring asthma, hypoxia, forced exhaled nitric oxide, inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of Graz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

hypoxia

sham hypoxia

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 26, 2015
Last Updated
March 11, 2015
Sponsor
Medical University of Graz
Collaborators
Ludwig Boltzmann Institute for Lung Vascular Research
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1. Study Identification

Unique Protocol Identification Number
NCT02391090
Brief Title
FeNO After Hypoxia in Asthma Patients
Official Title
Effects of Intermittent Hypoxia on the Asthmatic Inflammation of Asthma Patients - a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz
Collaborators
Ludwig Boltzmann Institute for Lung Vascular Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, hypoxia, forced exhaled nitric oxide, inflammation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hypoxia
Arm Type
Experimental
Arm Description
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
Arm Title
sham hypoxia
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
hypoxia in hypoxic chamber
Intervention Description
Intervention lasts 4 hours per day for 6 days in a row.
Intervention Type
Device
Intervention Name(s)
sham hypoxia in hypoxic chamber
Intervention Description
Intervention lasts 4 hours per day for 6 days in a row.
Intervention Type
Procedure
Intervention Name(s)
Pulse oximetry
Intervention Description
Pulse oximetry will be performed hourly during sessions in the hypoxic chamber for safety reasons.
Intervention Type
Other
Intervention Name(s)
Asthma and Quality of Life Questionnaires
Intervention Description
Before every session in the hypoxic chamber as well as on the day after the last session will be completed.
Intervention Type
Procedure
Intervention Name(s)
Lung function testing
Intervention Description
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
Intervention Name(s)
Blood taking
Intervention Description
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
Intervention Name(s)
FeNO measurement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in forced exhaled nitric oxide after 6 days of hypoxia/sham
Description
Forced exhaled nitric oxide will be measured every day before and after the treatment
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Change in blood parameters after 6 days of hypoxia/sham
Description
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
Time Frame
1 week
Title
Change in lung function parameters after 6 days of hypoxia/sham
Description
Lung function testing will be performed before the first and after the last intervention
Time Frame
1 week
Title
Change in Quality of Life and Asthma questionnaires after 6 days of hypoxia/sham
Description
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
Time Frame
1 week
Title
Change in finger pulse oximetry
Description
Finger pulse oximetry will be measured hourly during the intervention for safety reasons.
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Horst Olschewski, MD, Prof.
Organizational Affiliation
Medical University of Graz, Department of Internal Medicine, Division of Pulmonology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz
City
Graz
State/Province
Styria
ZIP/Postal Code
8036
Country
Austria

12. IPD Sharing Statement

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FeNO After Hypoxia in Asthma Patients

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