- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02143609
Patients With Chronic Obstructive Pulmonary Disease at Altitude - Effect of Nocturnal Oxygen on Exercise Performance
May 13, 2019 updated by: University of Zurich
Patients With Chronic Obstructive Pulmonary Disease at Altitude - Effect of Nocturnal Oxygen Therapy on Exercise Performance
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Zurich, Switzerland, CH-8091
- University Hospital Zurich, Pulmonary Division
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Oxygen
oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
|
Nocturnal nasal oxygen during stay at 2048 m
Other Names:
Sham oxygen (room air) via nasal cannula, 3 L/min, at 2048 m
Other Names:
|
Placebo Comparator: Sham oxygen
sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
|
Nocturnal nasal oxygen during stay at 2048 m
Other Names:
Sham oxygen (room air) via nasal cannula, 3 L/min, at 2048 m
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
6 min walk distance
Time Frame: Day 2 at 2048 m
|
Difference in the distance walked in 6 min between the oxygen and sham oxygen period
|
Day 2 at 2048 m
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
6 min walk distance
Time Frame: day 3 at 2048 m
|
Difference in the distance walked in 6 min between the oxygen and sham oxygen period
|
day 3 at 2048 m
|
Arterial blood gas analysis
Time Frame: Day 2 at 2048 m
|
Difference in arterial oxygen partial pressure, carbon dioxide partial pressure, and pH
|
Day 2 at 2048 m
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Spirometry
Time Frame: Day 2 at 2048 m
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Difference in spirometric variables between the oxygen and sham oxygen period
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Day 2 at 2048 m
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Perceived exertion
Time Frame: Day 2 at 2048 m
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Difference in perceived exertion rated with the BORG CR10 scale at the end of the 6 min walk
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Day 2 at 2048 m
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Perceived exertion
Time Frame: Day 3 at 2048 m
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Difference in perceived exertion rated with the BORG CR10 scale at the end of the 6 min walk
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Day 3 at 2048 m
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Severe hypoxemia
Time Frame: Day 1 to 3 at 2048 m
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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.
|
Day 1 to 3 at 2048 m
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2014
Primary Completion (Actual)
October 31, 2014
Study Completion (Actual)
October 31, 2014
Study Registration Dates
First Submitted
May 18, 2014
First Submitted That Met QC Criteria
May 20, 2014
First Posted (Estimate)
May 21, 2014
Study Record Updates
Last Update Posted (Actual)
May 14, 2019
Last Update Submitted That Met QC Criteria
May 13, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-0088V2A3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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