Patients With Chronic Obstructive Pulmonary Disease at Altitude - Effect of Nocturnal Oxygen on Exercise Performance

Study Overview
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Brief Summary
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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
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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).

Official Title
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Patients With Chronic Obstructive Pulmonary Disease at Altitude - Effect of Nocturnal Oxygen Therapy on Exercise Performance

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Drug: oxygen
* Drug: sham oxygen (room air)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxygen<br>oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m | Drug: oxygen<br>* Nocturnal nasal oxygen during stay at 2048 m<br>* Other names: Nocturnal oxygen via nasal cannula, 3 L/min, at 2048 m;Drug: sham oxygen (room air)<br>* Sham oxygen (room air) via nasal cannula, 3 L/min, at 2048 m<br>* Other names: Nocturnal nasal room air during stay at 2048 m;|
| Placebo Comparator: Sham oxygen<br>sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m | Drug: oxygen<br>* Nocturnal nasal oxygen during stay at 2048 m<br>* Other names: Nocturnal oxygen via nasal cannula, 3 L/min, at 2048 m;Drug: sham oxygen (room air)<br>* Sham oxygen (room air) via nasal cannula, 3 L/min, at 2048 m<br>* Other names: Nocturnal nasal room air during stay at 2048 m;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 min walk distance | 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 | Difference in the distance walked in 6 min between the oxygen and sham oxygen period | day 3 at 2048 m | 
| Arterial blood gas analysis | Difference in arterial oxygen partial pressure, carbon dioxide partial pressure, and pH | Day 2 at 2048 m | 
| Spirometry | Difference in spirometric variables between the oxygen and sham oxygen period | Day 2 at 2048 m | 
| Perceived exertion | Difference in perceived exertion rated with the BORG CR10 scale at the end of the 6 min walk | Day 2 at 2048 m | 
| Perceived exertion | Difference in perceived exertion rated with the BORG CR10 scale at the end of the 6 min walk | Day 3 at 2048 m | 
| 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. | Day 1 to 3 at 2048 m | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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airway disease, bronchitis, emphysema, lung