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

This study is currently recruiting participants.
Verified January 2017 by University of Zurich
Sponsor:
ClinicalTrials.gov Identifier:
NCT02143609
First Posted: May 21, 2014
Last Update Posted: January 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Zurich
  Purpose
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.

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: oxygen Drug: sham oxygen (room air) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Patients With Chronic Obstructive Pulmonary Disease at Altitude - Effect of Nocturnal Oxygen Therapy on Exercise Performance

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

  • Arterial blood gas analysis [ Time Frame: Day 2 at 2048 m ]
    Difference in arterial oxygen partial pressure, carbon dioxide partial pressure, and pH

  • Spirometry [ Time Frame: Day 2 at 2048 m ]
    Difference in spirometric variables between the oxygen and sham oxygen period

  • 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

  • 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

  • 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.


Estimated Enrollment: 50
Study Start Date: May 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oxygen
oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
Drug: oxygen
Nocturnal nasal oxygen during stay at 2048 m
Other Name: Nocturnal oxygen via nasal cannula, 3 L/min, at 2048 m
Drug: sham oxygen (room air)
Sham oxygen (room air) via nasal cannula, 3 L/min, at 2048 m
Other Name: 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
Drug: oxygen
Nocturnal nasal oxygen during stay at 2048 m
Other Name: Nocturnal oxygen via nasal cannula, 3 L/min, at 2048 m
Drug: sham oxygen (room air)
Sham oxygen (room air) via nasal cannula, 3 L/min, at 2048 m
Other Name: Nocturnal nasal room air during stay at 2048 m

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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02143609


Contacts
Contact: Konrad E Bloch, MD +41 44 255 3828 konrad.bloch@usz.ch
Contact: Tsogayl D Latshang, MD +41 44 255 3828 tsogyal.latshang@usz.ch

Locations
Switzerland
University Hospital Zurich, Pulmonary Division Recruiting
Zurich, Switzerland, CH-8091
Contact: Konrad E Bloch, MD    +41 44 255 3828    konrad.bloch@usz.ch   
Principal Investigator: Konrad E Bloch, MD         
Sponsors and Collaborators
University of Zurich
Investigators
Study Chair: Konrad E Bloch, MD University Hospital, Zürich
  More Information

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02143609     History of Changes
Other Study ID Numbers: 2013-0088V2A3
First Submitted: May 18, 2014
First Posted: May 21, 2014
Last Update Posted: January 4, 2017
Last Verified: January 2017

Keywords provided by University of Zurich:
airway disease
bronchitis
emphysema
lung

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases