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

University of Zurich (UZH)

Status and phase: Completed; Phase 4

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: sham oxygen (room air); Drug: oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT02143609

2013-0088V2A3

Details and patient eligibility

About

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.

Full 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).

Enrollment: 32 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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32 participants in 2 patient groups, including a placebo group

Oxygen

Active Comparator group

Description:

oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m

Treatment:

Drug: oxygen

Drug: sham oxygen (room air)

Sham oxygen

Placebo Comparator group

Description:

sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m

Treatment:

Drug: oxygen

Drug: sham oxygen (room air)