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Completed

NCT Number: NCT02391090

FeNO After Hypoxia in Asthma Patients

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Graz

Graz, Styria, 8036, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hypoxia in hypoxic chamber

Device

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

sham hypoxia in hypoxic chamber

Device

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

Pulse oximetry

Procedure

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

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.

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.

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.

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Change in finger pulse oximetry

    Time frame: 1 week

    Finger pulse oximetry will be measured hourly during the intervention for safety reasons.

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Collaborators

  • Ludwig Boltzmann Institute for Lung Vascular Research

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 18, 2015
Registry last updated
Mar 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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