Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
airway disease, bronchitis, emphysema, lung
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).
Interventions
DRUGoxygen
Nocturnal nasal oxygen during stay at 2048 m
Sham oxygen (room air) via nasal cannula, 3 L/min, at 2048 m
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6 min walk distance | Day 2 at 2048 m | Difference in the distance walked in 6 min between the oxygen and sham oxygen period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6 min walk distance | day 3 at 2048 m | Difference in the distance walked in 6 min between the oxygen and sham oxygen period |
| Arterial blood gas analysis | Day 2 at 2048 m | Difference in arterial oxygen partial pressure, carbon dioxide partial pressure, and pH |
| Spirometry | Day 2 at 2048 m | Difference in spirometric variables between the oxygen and sham oxygen period |
| Perceived exertion | Day 2 at 2048 m | Difference in perceived exertion rated with the BORG CR10 scale at the end of the 6 min walk |
| Severe hypoxemia | Day 1 to 3 at 2048 m | 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. |
Countries
Switzerland
Outcome results
None listed