Effect of Long-term Oxygen Therapy on Exercise Capacity and Quality of Life in Patients With Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension
1 other identifier
interventional
30
1 country
1
Brief Summary
In this randomized-controlled, cross-over trial the investigators test the effect of long-term oxygen therapy (\> 16h/day) given for 5 weeks with a wash-out period between phases of 2 weeks on exercise performance and quality of life and many physiological parameters in patients with pulmonary arterial and chronic thromboembolic pulmonary hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2013
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 13, 2013
CompletedFirst Posted
Study publicly available on registry
June 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedMay 5, 2017
May 1, 2017
3.8 years
May 13, 2013
May 4, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
6 minute walk test
6 minute walk distance according to american thoracic society (ATS) guidelines
5 weeks
Quality of life
QoL assessed by the short form of the medical outcome questionnaire (SF-36) physical functioning scale
5 weeks
Secondary Outcomes (9)
Daily activity
5 week
hemodynamics by echocardiography
5 weeks
quality of life
5 weeks
arterial blood gas
5 weeks
operating hours of oxygen concentrator
5 weeks
- +4 more secondary outcomes
Study Arms (2)
Supplemental oxygen
EXPERIMENTALSupplemental oxygen 3 liters/minute given via a nasal cannula for 16 hours a day
Sham room air
SHAM COMPARATORRoom air given at a flow rate of 3 liters per minute for 16 hours a day
Interventions
Eligibility Criteria
You may qualify if:
- \- Adult patients with established diagnosis of pulmonary arterial or chronic thromboembolic pulmonary hypertension (class I and IV according to the latest WHO classification scheme of Dana Point 2008) on optimized medical therapy and in stable condition for at least 4 weeks, who desaturate in the 6 minute walking test by =4% to values \<92%.
You may not qualify if:
- Patients in unstable conditions requiring frequent therapeutic adaption
- pregnant women
- patients with pulmonary venous hypertension due to left heart diseases
- patients with relevant concomitant lung disease and severe daytime hypoxemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Zurich, Division of Pneumology
Zurich, Canton of Zurich, 8091, Switzerland
Study Officials
- PRINCIPAL INVESTIGATOR
Silvia Ulrich Somaini, MD
University Hospital Zurich, Division of Pneumology
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2013
First Posted
June 21, 2013
Study Start
May 1, 2013
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
May 5, 2017
Record last verified: 2017-05