Patients With Chronic Obstructive Pulmonary Disease at Altitude

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-01

Study Completion Date

2014-10-31

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 breathing and sleep of patients with chronic obstructive lung disease.

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Detailed Description

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Patients with moderate to severe chronic obstructive pulmonary disease living below 800 m will be invited to participate in a randomized, cross-over field trial evaluating the hypothesis that nocturnal breathing and sleep during nights spent at moderate altitude are improved by oxygen therapy via a nasal cannula compared to room air (sham oxygen). Outcomes will be assessed at low altitude (Zurich, 490 m, baseline), and during 2 study periods of 2 nights each spent at moderate altitude (St. Moritz Salastrains, 2048 m) separated by a wash-out period of at least 2 weeks spent at low altitude (\<800 m).

Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Oxygen

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

Group Type ACTIVE_COMPARATOR

Oxygen

Intervention Type DRUG

Nocturnal nasal oxygen during stay at 2048 m

sham oxygen (room air)

Intervention Type DRUG

Sham oxygen

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

Group Type PLACEBO_COMPARATOR

Oxygen

Intervention Type DRUG

Nocturnal nasal oxygen during stay at 2048 m

sham oxygen (room air)

Intervention Type DRUG

Interventions

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Oxygen

Nocturnal nasal oxygen during stay at 2048 m

Intervention Type DRUG

sham oxygen (room air)

Intervention Type DRUG

Other Intervention Names

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Nocturnal nasal room air during stay at 2048 m

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No