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

May 13, 2019 updated by: University of Zurich

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

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Zurich, Switzerland, CH-8091
        • University Hospital Zurich, Pulmonary Division

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oxygen
oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
Nocturnal nasal oxygen during stay at 2048 m
Other Names:
  • Nocturnal oxygen via nasal cannula, 3 L/min, at 2048 m
Sham oxygen (room air) via nasal cannula, 3 L/min, at 2048 m
Other Names:
  • Nocturnal nasal room air during stay at 2048 m
Placebo Comparator: Sham oxygen
sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
Nocturnal nasal oxygen during stay at 2048 m
Other Names:
  • Nocturnal oxygen via nasal cannula, 3 L/min, at 2048 m
Sham oxygen (room air) via nasal cannula, 3 L/min, at 2048 m
Other Names:
  • Nocturnal nasal room air during stay at 2048 m

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 min walk distance
Time Frame: Day 2 at 2048 m
Difference in the distance walked in 6 min between the oxygen and sham oxygen period
Day 2 at 2048 m

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 min walk distance
Time Frame: day 3 at 2048 m
Difference in the distance walked in 6 min between the oxygen and sham oxygen period
day 3 at 2048 m
Arterial blood gas analysis
Time Frame: Day 2 at 2048 m
Difference in arterial oxygen partial pressure, carbon dioxide partial pressure, and pH
Day 2 at 2048 m
Spirometry
Time Frame: Day 2 at 2048 m
Difference in spirometric variables between the oxygen and sham oxygen period
Day 2 at 2048 m
Perceived exertion
Time Frame: Day 2 at 2048 m
Difference in perceived exertion rated with the BORG CR10 scale at the end of the 6 min walk
Day 2 at 2048 m
Perceived exertion
Time Frame: Day 3 at 2048 m
Difference in perceived exertion rated with the BORG CR10 scale at the end of the 6 min walk
Day 3 at 2048 m
Severe hypoxemia
Time Frame: 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.
Day 1 to 3 at 2048 m

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

October 31, 2014

Study Completion (Actual)

October 31, 2014

Study Registration Dates

First Submitted

May 18, 2014

First Submitted That Met QC Criteria

May 20, 2014

First Posted (Estimate)

May 21, 2014

Study Record Updates

Last Update Posted (Actual)

May 14, 2019

Last Update Submitted That Met QC Criteria

May 13, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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