Pulmonary Arterial and Chronic Thromboembolic Pulmonary HypertensionPhase 3NCT01884012
Effect of Long-term Oxygen Therapy on Exercise Capacity and Quality of Life in Patients With Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension
A Phase 3 study testing long term oxygen therapy in people with Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension, run by University of Zurich at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 85 years
- Conditions the study is for
- Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension
- What is being tested?
- long term oxygen therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2013to Mar 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Pneumology
Zurich, Canton of Zurich, 8091
About this study
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.
- Being tested
- long term oxygen therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
long term oxygen therapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Supplemental oxygen | Experimental | Supplemental oxygen 3 liters/minute given via a nasal cannula for 16 hours a day Receives: Procedure: long term oxygen therapy |
| Sham room air | Sham comparator | Room air given at a flow rate of 3 liters per minute for 16 hours a day Receives: Procedure: long term oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walk test
6 minute walk distance according to american thoracic society (ATS) guidelines
Measured: 5 weeks
Quality of life
QoL assessed by the short form of the medical outcome questionnaire (SF-36) physical functioning scale
Measured: 5 weeks
Secondary outcomes (9)
Daily activity
measured by actigraphy
Measured: 5 week
hemodynamics by echocardiography
Full echocardiographic assessment
Measured: 5 weeks
quality of life
SF-36
Measured: 5 weeks
arterial blood gas
partial pressure of oxygen (PaO2)
Measured: 5 weeks
operating hours of oxygen concentrator
efficacy of oxygen treatment
Measured: 5 weeks
mean nocturnal oxygen saturation
Ambulatory Sleep Study
Measured: 5 weeks
tests of cognitive performance
STROOP-Test
Measured: 5 weeks
Quality of life
Minnesota living with heart failure questionnaire
Measured: 5 weeks
Venous blood
N-terminal brain natriuretic peptide (NT-proBNP)
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial and Chronic Thromboembolic Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvia Ulrich Somaini, MD, Principal investigator, University Hospital Zurich, Division of Pneumology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884012
- Sponsor's protocol ID
- KEK 2012-0538
- Status last verified
- May 2017
- First submitted
- 13 May 2013
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Long-term Oxygen Therapy on Exercise Capacity and Quality of Life in Patients With Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT01884012
- Acronym / sponsor ID
- KEK 2012-0538
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 21 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplemental oxygen | Experimental | Procedure: long term oxygen therapySupplemental oxygen 3 liters/minute given via a nasal cannula for 16 hours a day |
| Sham room air | Sham comparator | Procedure: long term oxygen therapyRoom air given at a flow rate of 3 liters per minute for 16 hours a day |
Who may qualify
- Ages
- 16 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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%.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| long term oxygen therapy | Procedure or surgery | Sham room air, Supplemental oxygen |
Primary outcome
6 minute walk test
Time frame: 5 weeks
6 minute walk distance according to american thoracic society (ATS) guidelines
Quality of life
Time frame: 5 weeks
QoL assessed by the short form of the medical outcome questionnaire (SF-36) physical functioning scale
9 secondary outcomes
Daily activity
Time frame: 5 week
hemodynamics by echocardiography
Time frame: 5 weeks
quality of life
Time frame: 5 weeks
arterial blood gas
Time frame: 5 weeks
operating hours of oxygen concentrator
Time frame: 5 weeks
mean nocturnal oxygen saturation
Time frame: 5 weeks
tests of cognitive performance
Time frame: 5 weeks
Quality of life
Time frame: 5 weeks
Venous blood
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Ulrich Somaini, MD principal investigator
University Hospital Zurich, Division of Pneumology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing long term oxygen therapy in people with Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minute walk test (time frame: 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017.