FeNO After Hypoxia in Asthma Patients

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02391090
• Other study ID #: MUG-FeNO-2013
• Status: Completed
• Phase: N/A
• First received: January 26, 2015
• Last updated: March 11, 2015
• Start date: November 2014
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• hypoxia in hypoxic chamber
Intervention lasts 4 hours per day for 6 days in a row.
• sham 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.
• 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.
• 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.

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz	Styria

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Graz	Ludwig Boltzmann Institute of Lung Vascular Research

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	1 week	No
Secondary	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	1 week	No
Secondary	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	1 week	No
Secondary	Change in finger pulse oximetry	Finger pulse oximetry will be measured hourly during the intervention for safety reasons.	1 week	Yes