Back to resultsEffect of Short-term Oxygen During CPET in COPD
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Oxygen application
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria:
- diagnosis of chronic obstructive pulmonary disease
- on optimized medical therapy and in stable condition for at least 4 week
- desaturate in the 6 minute walking test by at least 4% to values <92%
Exclusion Criteria:
- unstable conditions
- pregnant women
- patients with relevant concomitant lung disease and severe daytime hypoxemia
Sites / Locations
- University Hospital Zurich, Division of Pneumology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Supplemental oxygen
Sham room air
Arm Description
Supplemental oxygen will be applied via a mask during CPET
Room air will be applied similarly to oxygen
Outcomes
Primary Outcome Measures
Watt
Exercise time
Secondary Outcome Measures
Peak Oxygen uptake
Respiratory Exchange ratio
Ventilatory equivalent of carbon dioxide (VE/VCO2) slope
End-tidal pressures of carbon dioxide (PET CO2)
Changes in arterial blood parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03196089
Brief Title
Effect of Short-term Oxygen During CPET in COPD
Official Title
Effect of Short-term Oxygen Therapy on Cardiopulmonary Exercise (CPET) Capacity in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 2, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In a randomized, sham-controlled trial the investigators will test whether supplemental oxygen given during cardiopulmonary exercise testing will improve exercise performance and physiological parameters in patients with chronic obstructive pulmonary disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supplemental oxygen
Arm Type
Experimental
Arm Description
Supplemental oxygen will be applied via a mask during CPET
Arm Title
Sham room air
Arm Type
Sham Comparator
Arm Description
Room air will be applied similarly to oxygen
Intervention Type
Procedure
Intervention Name(s)
Oxygen application
Intervention Description
Supplemental oxygen via mask
Primary Outcome Measure Information:
Title
Watt
Time Frame
1 day
Title
Exercise time
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Peak Oxygen uptake
Time Frame
1 day
Title
Respiratory Exchange ratio
Time Frame
1 day
Title
Ventilatory equivalent of carbon dioxide (VE/VCO2) slope
Time Frame
1 day
Title
End-tidal pressures of carbon dioxide (PET CO2)
Time Frame
1 day
Title
Changes in arterial blood parameters
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of chronic obstructive pulmonary disease
on optimized medical therapy and in stable condition for at least 4 week
desaturate in the 6 minute walking test by at least 4% to values <92%
Exclusion Criteria:
unstable conditions
pregnant women
patients with relevant concomitant lung disease and severe daytime hypoxemia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia Ulrich Somaini, Prof. Dr.
Organizational Affiliation
University Hospital Zurich, Division of Pneumology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Division of Pneumology
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Short-term Oxygen During CPET in COPD
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