Back to resultsPatients With Chronic Obstructive Pulmonary Disease at Altitude - Effect of Nocturnal Oxygen on Exercise Performance
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
oxygen
sham oxygen (room air)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring airway disease, bronchitis, emphysema, lung
Eligibility Criteria
Inclusion Criteria:
- chronic obstructive pulmonary disease (COPD), GOLD grade 2-3
- residents at low altitude (<800 m)
Exclusion Criteria:
- unstable condition, COPD exacerbation
- mild (GOLD 1) or very severe COPD (GOLD 4)
- requirement for oxygen therapy at low altitude residence
- hypoventilation
- pulmonary hypertension
- more than mild or unstable cardiovascular disease
- use of drugs that affect respiratory center drive
- internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (>20 cigarettes per day), inability to perform 6 min walk test.
- previous intolerance to moderate altitude (<2600m).
- exposure to altitudes >1500m for >2 days within the last 4 weeks before the study.
- pregnant or nursing patients
Sites / Locations
- University Hospital Zurich, Pulmonary Division
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Oxygen
Sham oxygen
Arm Description
oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
Outcomes
Primary Outcome Measures
6 min walk distance
Difference in the distance walked in 6 min between the oxygen and sham oxygen period
Secondary Outcome Measures
6 min walk distance
Difference in the distance walked in 6 min between the oxygen and sham oxygen period
Arterial blood gas analysis
Difference in arterial oxygen partial pressure, carbon dioxide partial pressure, and pH
Spirometry
Difference in spirometric variables between the oxygen and sham oxygen period
Perceived exertion
Difference in perceived exertion rated with the BORG CR10 scale at the end of the 6 min walk
Perceived exertion
Difference in perceived exertion rated with the BORG CR10 scale at the end of the 6 min walk
Severe hypoxemia
Number of participants in whom arterial oxygen saturation measured by pulse oximetry is less than 75% for more than 30 min during the oxygen and sham oxygen treatment periods at 2028 m.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02143609
Brief Title
Patients With Chronic Obstructive Pulmonary Disease at Altitude - Effect of Nocturnal Oxygen on Exercise Performance
Official Title
Patients With Chronic Obstructive Pulmonary Disease at Altitude - Effect of Nocturnal Oxygen Therapy on Exercise Performance
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
October 31, 2014 (Actual)
Study Completion Date
October 31, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the effect of nocturnal oxygen therapy during a stay at moderate altitude on exercise performance of patients with chronic obstructive lung disease.
Detailed Description
Patients with moderate to severe COPD living below 800 m, will be recruited to participate in a randomized cross-over field trial evaluating the hypothesis that exercise capacity during a 2 day sojourn at moderate altitude is improved by nocturnal oxygen therapy via a nasal cannula. Outcomes will be assessed during 2 days in Zurich (490 m, low altitude baseline), and during 2 days at St. Moritz Salastrains (2048 m).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
airway disease, bronchitis, emphysema, lung
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxygen
Arm Type
Active Comparator
Arm Description
oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
Arm Title
Sham oxygen
Arm Type
Placebo Comparator
Arm Description
sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
Intervention Type
Drug
Intervention Name(s)
oxygen
Other Intervention Name(s)
Nocturnal oxygen via nasal cannula, 3 L/min, at 2048 m
Intervention Description
Nocturnal nasal oxygen during stay at 2048 m
Intervention Type
Drug
Intervention Name(s)
sham oxygen (room air)
Other Intervention Name(s)
Nocturnal nasal room air during stay at 2048 m
Intervention Description
Sham oxygen (room air) via nasal cannula, 3 L/min, at 2048 m
Primary Outcome Measure Information:
Title
6 min walk distance
Description
Difference in the distance walked in 6 min between the oxygen and sham oxygen period
Time Frame
Day 2 at 2048 m
Secondary Outcome Measure Information:
Title
6 min walk distance
Description
Difference in the distance walked in 6 min between the oxygen and sham oxygen period
Time Frame
day 3 at 2048 m
Title
Arterial blood gas analysis
Description
Difference in arterial oxygen partial pressure, carbon dioxide partial pressure, and pH
Time Frame
Day 2 at 2048 m
Title
Spirometry
Description
Difference in spirometric variables between the oxygen and sham oxygen period
Time Frame
Day 2 at 2048 m
Title
Perceived exertion
Description
Difference in perceived exertion rated with the BORG CR10 scale at the end of the 6 min walk
Time Frame
Day 2 at 2048 m
Title
Perceived exertion
Description
Difference in perceived exertion rated with the BORG CR10 scale at the end of the 6 min walk
Time Frame
Day 3 at 2048 m
Title
Severe hypoxemia
Description
Number of participants in whom arterial oxygen saturation measured by pulse oximetry is less than 75% for more than 30 min during the oxygen and sham oxygen treatment periods at 2028 m.
Time Frame
Day 1 to 3 at 2048 m
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
chronic obstructive pulmonary disease (COPD), GOLD grade 2-3
residents at low altitude (<800 m)
Exclusion Criteria:
unstable condition, COPD exacerbation
mild (GOLD 1) or very severe COPD (GOLD 4)
requirement for oxygen therapy at low altitude residence
hypoventilation
pulmonary hypertension
more than mild or unstable cardiovascular disease
use of drugs that affect respiratory center drive
internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (>20 cigarettes per day), inability to perform 6 min walk test.
previous intolerance to moderate altitude (<2600m).
exposure to altitudes >1500m for >2 days within the last 4 weeks before the study.
pregnant or nursing patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konrad E Bloch, MD
Organizational Affiliation
University Hospital, Zürich
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Zurich, Pulmonary Division
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland
12. IPD Sharing Statement
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Patients With Chronic Obstructive Pulmonary Disease at Altitude - Effect of Nocturnal Oxygen on Exercise Performance
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