AsthmaNCT02391090
FeNO After Hypoxia in Asthma Patients
A study testing hypoxia in hypoxic chamber, Pulse oximetry and Asthma and Quality of Life Questionnaires in people with Asthma, run by Medical University of Graz at 1 site in Austria.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- hypoxia in hypoxic chamber, Pulse oximetry and Asthma and Quality of Life Questionnaires
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stable Asthma (GINA 1-2)
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Asthma
- Being tested
- hypoxia in hypoxic chamber, sham hypoxia in hypoxic chamber, Pulse oximetry, Asthma and Quality of Life Questionnaires, Lung function testing
- Keywords
- asthma, hypoxia, forced exhaled nitric oxide, inflammation
- Medical subject headings
- Asthma, Hypoxia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypoxia in hypoxic chamberDevice
Intervention lasts 4 hours per day for 6 days in a row.
sham hypoxia in hypoxic chamberDevice
Intervention lasts 4 hours per day for 6 days in a row.
Pulse oximetryProcedure or surgery
Pulse oximetry will be performed hourly during sessions in the hypoxic chamber for safety reasons.
Asthma and Quality of Life QuestionnairesOther
Before every session in the hypoxic chamber as well as on the day after the last session will be completed.
Lung function testingProcedure or surgery
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 takingProcedure or surgery
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 measurementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week
Secondary outcomes (4)
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
Measured: 1 week
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
Measured: 1 week
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
Measured: 1 week
Change in finger pulse oximetry
Finger pulse oximetry will be measured hourly during the intervention for safety reasons.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startNov 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig Boltzmann Institute for Lung Vascular Research
- Responsible party
- Sponsor
- Investigators
- Horst Olschewski, MD, Prof., Principal investigator, Medical University of Graz, Department of Internal Medicine, Division of Pulmonology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391090
- Sponsor's protocol ID
- MUG-FeNO-2013
- Status last verified
- Mar 2015
- First submitted
- 26 Jan 2015
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intermittent Hypoxia on the Asthmatic Inflammation of Asthma Patients - a Pilot Study
- ClinicalTrials.gov ID
- NCT02391090
- Acronym / sponsor ID
- MUG-FeNO-2013
- Conditions
- Asthma
- Keywords
- asthma, hypoxia, forced exhaled nitric oxide, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Ludwig Boltzmann Institute for Lung Vascular Research
- Study start
- Nov 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 18 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypoxia | Experimental | Device: hypoxia in hypoxic chamber, Procedure: Pulse oximetry, Other: Asthma and Quality of Life Questionnaires, Procedure: Lung function testing, Procedure: Blood taking, Procedure: FeNO measurementThe 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 |
| sham hypoxia | Sham comparator | 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 measurementThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- stable Asthma (GINA 1-2)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypoxia in hypoxic chamberIntervention lasts 4 hours per day for 6 days in a row. | Device | hypoxia |
| sham hypoxia in hypoxic chamberIntervention lasts 4 hours per day for 6 days in a row. | Device | sham hypoxia |
| Pulse oximetryPulse oximetry will be performed hourly during sessions in the hypoxic chamber for safety reasons. | Procedure or surgery | hypoxia, sham hypoxia |
| Asthma and Quality of Life QuestionnairesBefore every session in the hypoxic chamber as well as on the day after the last session will be completed. | Other | hypoxia, sham hypoxia |
| Lung function testingOn 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 or surgery | hypoxia, sham hypoxia |
| Blood takingOn 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 or surgery | hypoxia, sham hypoxia |
| FeNO measurementBefore 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. | Procedure or surgery | hypoxia, sham hypoxia |
Primary outcome
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
4 secondary outcomes
Change in blood parameters after 6 days of hypoxia/sham
Time frame: 1 week
Change in lung function parameters after 6 days of hypoxia/sham
Time frame: 1 week
Change in Quality of Life and Asthma questionnaires after 6 days of hypoxia/sham
Time frame: 1 week
Change in finger pulse oximetry
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Horst Olschewski, MD, Prof. principal investigator
Medical University of Graz, Department of Internal Medicine, Division of Pulmonology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypoxia in hypoxic chamber, Pulse oximetry and Asthma and Quality of Life Questionnaires in people with Asthma, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in forced exhaled nitric oxide after 6 days of hypoxia/sham (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2015.