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

Phase 4

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Drug: oxygen; Drug: sham oxygen (room air)

• Registration Number: NCT02143609
• Lead Sponsor: University of Zurich

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).

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-18
• Study First Submitted QC: 2014-05-20
• Study First Posted: 2014-05-21
• Primary Completion: 2014-10-31
• Study Completion: 2014-10-31
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-13
• Last Update Posted: 2019-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Perceived exertion	Day 3 at 2048 m	Difference in perceived exertion rated with the BORG CR10 scale at the end of the 6 min walk
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
6 min walk distance	day 3 at 2048 m	Difference in the distance walked in 6 min between the oxygen and sham oxygen period
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.

Trial Locations

Locations (1)

University Hospital Zurich, Pulmonary Division; 🇨🇭 Zurich, Switzerland