Back to resultsPatients With Pulmonary Hypertension or Interstitial Lung Disease at Altitude - Effect of Oxygen on Exercise Performance
Primary Purpose
Precapillary Pulmonary Hypertension, Interstitial Lung Disease
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Moderate altitude sojourn
Low altitude sojourn
Oxygen
Sham oxygen (room air)
Sponsored by
About this trial
This is an interventional treatment trial for Precapillary Pulmonary Hypertension focused on measuring Pulmonary hypertension, Interstitial lung disease, Pulmonary fibrosis
Eligibility Criteria
Inclusion Criteria:
- Precapillary pulmonary hypertension, or interstitial lung disease.
- New York Heart Association class 2-3.
- Residence at low altitude (<800m).
Exclusion Criteria:
- Unstable or exacerbated condition
- Very severe pulmonary hypertension or interstitial lung disease, New York Heart Association class 4
- Requirement for oxygen therapy at low altitude residence
- Hypoventilation
- 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
Sites / Locations
- University Hospital Zurich, Pulmonary Division
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
Moderate altitude sojourn
Low altitude sojourn
Oxygen
Sham oxygen (room air)
Arm Description
Sojourn at moderate altitude (2048 m)
Sojourn at low altitude (490 m, baseline)
Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights
Outcomes
Primary Outcome Measures
6 min walk distance
Difference in the distance walked in 6 min between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2028 m.
Secondary Outcome Measures
6 min walk distance
Difference in the distance walked in 6 min between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2028 m.
Arterial blood gas analysis
Change in arterial oxygen partial pressure, carbon dioxide partial pressure, and pH between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2028 m.
Spirometry
Difference in spirometry between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2028 m.
Perceived exertion
Difference in the perceived exertion rated with the BORG CR10 scale at the end of the 6 min walk between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2028 m.
Perceived exertion
Difference in the perceived exertion rated with the BORG CR10 scale at the end of the 6 min walk between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2028 m.
Severe hypoxemia
Number of participants in whom arterial oxygen saturation measured by pulse oximetry is less than 75% for more than 30 min during the sojourn at 2048 m (altitude) and 490 m (baseline); and during the oxygen and sham oxygen treatment periods at 2028 m.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02143687
Brief Title
Patients With Pulmonary Hypertension or Interstitial Lung Disease at Altitude - Effect of Oxygen on Exercise Performance
Official Title
Patients With Pulmonary Hypertension or Interstitial Lung Disease Travelling to Altitude - Effect of Nocturnal Oxygen Therapy on Exercise Performance
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
October 2021 (Actual)
Study Completion Date
October 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the effect of travelling to moderate altitude and of nocturnal oxygen therapy during a stay at moderate altitude on exercise performance of patients with pulmonary hypertension or with interstitial lung disease.
Detailed Description
Patients with pulmonary hypertension or with interstitial lung disease living below 800 m will be invited to participate in a randomized, cross-over field trial evaluating the hypotheses that: a), exercise capacity during a 2 day sojourn at moderate altitude is reduced in comparison to low altitude; b), exercise capacity during a 2 day sojourn at moderate altitude is improved by nocturnal oxygen therapy compared to room air (sham oxygen) administered during nights at altitude. Outcomes will be assessed at low altitude (Zurich, 490 m, baseline), and during 2 study periods of 2 days each spent at moderate altitude (St. Moritz Salastrains, 2048 m), separated by a wash-out period of at least 2 weeks spent at low altitude (<800 m). The order of stays at the different altitudes and of the treatments will be randomized.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Precapillary Pulmonary Hypertension, Interstitial Lung Disease
Keywords
Pulmonary hypertension, Interstitial lung disease, Pulmonary fibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Moderate altitude sojourn
Arm Type
Experimental
Arm Description
Sojourn at moderate altitude (2048 m)
Arm Title
Low altitude sojourn
Arm Type
Experimental
Arm Description
Sojourn at low altitude (490 m, baseline)
Arm Title
Oxygen
Arm Type
Active Comparator
Arm Description
Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
Arm Title
Sham oxygen (room air)
Arm Type
Placebo Comparator
Arm Description
Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights
Intervention Type
Behavioral
Intervention Name(s)
Moderate altitude sojourn
Other Intervention Name(s)
Moderate altitude sojourn at 2048 m for 2 days
Intervention Description
Participants will travel from Zurich (490 m) to St. Moritz Salastrains (2048 m) and stay there for 2 days
Intervention Type
Behavioral
Intervention Name(s)
Low altitude sojourn
Other Intervention Name(s)
Low altitude sojourn at 490 m (Zurich) for 1.5 days
Intervention Description
Low altitude baseline evaluations will be performed during a stay at Zurich (490)
Intervention Type
Drug
Intervention Name(s)
Oxygen
Other Intervention Name(s)
Nocturnal nasal oxygen administration during stay at 2048 m
Intervention Description
Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
Intervention Type
Drug
Intervention Name(s)
Sham oxygen (room air)
Other Intervention Name(s)
Nocturnal nasal room air administration
Intervention Description
Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights at 490 m and 2048 m
Primary Outcome Measure Information:
Title
6 min walk distance
Description
Difference in the distance walked in 6 min between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2028 m.
Time Frame
Day 2 at 2048 m
Secondary Outcome Measure Information:
Title
6 min walk distance
Description
Difference in the distance walked in 6 min between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2028 m.
Time Frame
day 3 at 2048 m
Title
Arterial blood gas analysis
Description
Change in arterial oxygen partial pressure, carbon dioxide partial pressure, and pH between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2028 m.
Time Frame
Day 2 at 2048 m
Title
Spirometry
Description
Difference in spirometry between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2028 m.
Time Frame
Day 2 at 2048 m
Title
Perceived exertion
Description
Difference in the perceived exertion rated with the BORG CR10 scale at the end of the 6 min walk between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2028 m.
Time Frame
Day 2 at 2048 m
Title
Perceived exertion
Description
Difference in the perceived exertion rated with the BORG CR10 scale at the end of the 6 min walk between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2028 m.
Time Frame
Day 3 at 2048 m
Title
Severe hypoxemia
Description
Number of participants in whom arterial oxygen saturation measured by pulse oximetry is less than 75% for more than 30 min during the sojourn at 2048 m (altitude) and 490 m (baseline); and during the oxygen and sham oxygen treatment periods at 2028 m.
Time Frame
Day 1 to 3 at 2048 m
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Precapillary pulmonary hypertension, or interstitial lung disease.
New York Heart Association class 2-3.
Residence at low altitude (<800m).
Exclusion Criteria:
Unstable or exacerbated condition
Very severe pulmonary hypertension or interstitial lung disease, New York Heart Association class 4
Requirement for oxygen therapy at low altitude residence
Hypoventilation
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konrad E Bloch, MD
Organizational Affiliation
University Hospital, Zürich
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Zurich, Pulmonary Division
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland
12. IPD Sharing Statement
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Patients With Pulmonary Hypertension or Interstitial Lung Disease at Altitude - Effect of Oxygen on Exercise Performance
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