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Completed

NCT Number: NCT02143609

Patients With Chronic Obstructive Pulmonary Disease at Altitude - Effect of Nocturnal Oxygen 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Zurich, Pulmonary Division

Zurich, CH-8091, Switzerland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxygen

Drug

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)

Drug

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

Other names: Nocturnal nasal room air during stay at 2048 m

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Arterial blood gas analysis

    Time frame: Day 2 at 2048 m

    Difference in arterial oxygen partial pressure, carbon dioxide partial pressure, and pH

  3. Spirometry

    Time frame: Day 2 at 2048 m

    Difference in spirometric variables between the oxygen and sham oxygen period

  4. 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

  5. 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

  6. 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.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 21, 2014
Registry last updated
May 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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