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

NCT ID: NCT02143609

Last Updated: 2019-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2014-10-31

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).

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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 (room air) via nasal cannula, 3 L/min, at 2048 m

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

Sham oxygen (room air) via nasal cannula, 3 L/min, at 2048 m

Interventions

oxygen

Nocturnal nasal oxygen during stay at 2048 m

Intervention Type: DRUG

sham oxygen (room air)

Sham oxygen (room air) via nasal cannula, 3 L/min, at 2048 m

Intervention Type: DRUG

Other Intervention Names

Nocturnal oxygen via nasal cannula, 3 L/min, at 2048 m; Nocturnal nasal room air during stay at 2048 m

Eligibility Criteria

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

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Konrad E Bloch, MD

Role: STUDY_CHAIR

University Hospital, Zürich

Locations

University Hospital Zurich, Pulmonary Division

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

2013-0088V2A3

Identifier Type: -

Identifier Source: org_study_id