COPDNCT01673685
Trial of Portable Oxygen Cylinders Versus Battery Powered Portable Oxygen Concentrators
A study testing Portable Oxygen in people with COPD, run by The Queen Elizabeth Hospital at 1 site in Australia.
Trial summary
Randomised cross-over study of portable oxygen concentrators compared to oxygen cylinders to improve quality of life and other outcomes for patients with chronic obstructive pulmonary disease. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- COPD
- What is being tested?
- Portable Oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2010to Sep 2016
- Phase
- Interventional
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients diagnosed with stable COPD
- currently prescribed and using portable oxygen cylinders with a "pulsed" oxygen delivery for exertion.
Who cannot join
- Co-morbidities such as: other major respiratory conditions, cardiac or other substantial co-morbidities which significantly limit mobility independent of COPD
- Baseline step test which demonstrates a reduced effect on the battery device compared to oxygen cylinders.
Trial locations and contacts
1 site in 1 country.
Australia1 site
The Queen Elizabeth Hospital
Woodville Road, Woodville, South Australia, 5022
About this study
Official title: Randomised Crossover Trial of Portable Oxygen Cylinders Versus Battery Powered Portable Oxygen Concentrators
Randomised cross-over study of portable oxygen concentrators compared to oxygen cylinders to improve quality of life and other outcomes for patients with chronic obstructive pulmonary disease.
Read the detailed description
Many patients with Chronic Obstructive Pulmonary Disease (COPD) have limited activities of daily living (shopping, visiting friends, going for a walk) due to exertional dyspnoea. State Government funding provides up to 4 oxygen cylinders to be delivered to patients requiring portable oxygen per month. However, the more active and motivated COPD patients often find these gratis supplies run out well before the month is up. Recent technology has developed battery powered portable oxygen concentrators. The latest models weigh less than a typical oxygen cylinder and have the advantage that the battery plug can be plugged into a car cigarette lighter outlet, or into the power point of any house. This means that the COPD patient has the potential to be far more mobile for far longer periods of time and visit friends almost infinitely by recharging the battery pack during the course of their travels. The latest battery powered oxygen device weighs 2kgs which is about half that of an oxygen cylinder. However, there is an upfront expense to these devices and inevitably a sound business case with cost considerations (amortization of the initial purchase price, recharging the battery costing the patient's electricity etc) needs consideration. Also, before assuming these devices are superior (or at least as good as) oxygen cylinders, because they have a pulsed delivery of oxygen technology i.e. the oxygen is delivered in bursts with each inspiration that is detected, unlike oxygen cylinders which can run continuously, one cannot assume without rigorous evaluation that mobility and quality of life necessarily is good or superior with the new devices. Hence, quality of life evaluation with emphasis on enjoyed activities by each COPD patient are essential as well as costing issues for the funding stakeholder (i.e. hospital site specific funds). Should a sound business case be made (i.e. improved quality of life with less costs over a longer period of time), then a sound justification can be made to funding bodies that COPD patients are better off and the funding body is shouldering less cost by wider usage of these devices following evaluation of this project. The design will be a randomised crossover such that COPD patients will spend one month on oxygen or battery powered concentrator devices and then switch over to the other oxygen delivery. Chronic Respiratory Questionnaire (Quality of Life) will be administered at the end of each month.
- Conditions
- COPD
- Being tested
- Portable Oxygen
- Keywords
- COPD, Oxygen cylinder, Portable oxygen cylinder, Battery powered delivery device, mobility, dyspnoea, Quality of Life, Cost effectiveness
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable OxygenDevice
Also called Respironics Airsep (rental) AssetNumber 38269
| Study group | Role | What they receive |
|---|---|---|
| Portable Oxygen Cylinder | Placebo comparator | Portable Oxygen Cylinder Receives: Device: Portable Oxygen |
| Portable Oxygen Concentrator | Active comparator | Portable Oxygen Concentrator Receives: Device: Portable Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life as measured through Chronic Respiratory Questionnaire
only two subdomains of the Chronic Respiratory Questionnaire (CRQ) were used: the Shortness of Breath (SoB) domain and the Mastery domain
Measured: One month
Secondary outcomes (3)
Patient Preference
Five 7-point Likert Scales, ranging from 1 (none of the time) to 7 (all of the time) on portability ("the equipment was portable enough for my needs"), operation ("I was able to set up and operate the equipment properly"), noise ("Noise from the equipment affected me"), comprehension ("I was able to understand the functions of the equipment, e.g. alarms") and duration ("The oxygen lasted long enough for me to perform my normal activities"). Furthermore, patients were asked to provide comments on use of the POCs and the Cylinders after they completed the respective stage of the trial.
Measured: One month
Cost effectiveness of portable oxygen concentrator compared to cylinder
Economic assessment based on treatment cost, readmission data and hospital utilisation
Measured: one month
Quality of life as measured through AQoL-8D
Assessment of Quality of Life (AQoL)-8D Multi-Attribute Utility Instrument
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startOct 2010
- Primary completionJul 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Portable oxygen concentrators vs oxygen cylinders
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Queen Elizabeth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Carson, The Queen Elizabeth Hospital
- Investigators
- Brian J Smith, MBBS, FRACP, PhD, Principal investigator, The Queen Elizabeth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673685
- Sponsor's protocol ID
- 2010090
- Status last verified
- Apr 2017
- First submitted
- 15 Aug 2012
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: IPD will be available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Crossover Trial of Portable Oxygen Cylinders Versus Battery Powered Portable Oxygen Concentrators
- ClinicalTrials.gov ID
- NCT01673685
- Acronym / sponsor ID
- 2010090
- Conditions
- COPD
- Keywords
- COPD, Oxygen cylinder, Portable oxygen cylinder, Battery powered delivery device, mobility, dyspnoea, Quality of Life, Cost effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- The Queen Elizabeth HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jul 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 28 Aug 2012 (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.
Randomised cross-over study of portable oxygen concentrators compared to oxygen cylinders to improve quality of life and other outcomes for patients with chronic obstructive pulmonary disease.
Detailed description
Many patients with Chronic Obstructive Pulmonary Disease (COPD) have limited activities of daily living (shopping, visiting friends, going for a walk) due to exertional dyspnoea. State Government funding provides up to 4 oxygen cylinders to be delivered to patients requiring portable oxygen per month. However, the more active and motivated COPD patients often find these gratis supplies run out well before the month is up. Recent technology has developed battery powered portable oxygen concentrators. The latest models weigh less than a typical oxygen cylinder and have the advantage that the battery plug can be plugged into a car cigarette lighter outlet, or into the power point of any house. This means that the COPD patient has the potential to be far more mobile for far longer periods of time and visit friends almost infinitely by recharging the battery pack during the course of their travels. The latest battery powered oxygen device weighs 2kgs which is about half that of an oxygen cylinder. However, there is an upfront expense to these devices and inevitably a sound business case with cost considerations (amortization of the initial purchase price, recharging the battery costing the patient's electricity etc) needs consideration. Also, before assuming these devices are superior (or at least as good as) oxygen cylinders, because they have a pulsed delivery of oxygen technology i.e. the oxygen is delivered in bursts with each inspiration that is detected, unlike oxygen cylinders which can run continuously, one cannot assume without rigorous evaluation that mobility and quality of life necessarily is good or superior with the new devices. Hence, quality of life evaluation with emphasis on enjoyed activities by each COPD patient are essential as well as costing issues for the funding stakeholder (i.e. hospital site specific funds). Should a sound business case be made (i.e. improved quality of life with less costs over a longer period of time), then a sound justification can be made to funding bodies that COPD patients are better off and the funding body is shouldering less cost by wider usage of these devices following evaluation of this project. The design will be a randomised crossover such that COPD patients will spend one month on oxygen or battery powered concentrator devices and then switch over to the other oxygen delivery. Chronic Respiratory Questionnaire (Quality of Life) will be administered at the end of each month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Portable oxygen concentrators vs oxygen cylinders
| Arm | Type | Receives |
|---|---|---|
| Portable Oxygen Cylinder | Placebo comparator | Device: Portable OxygenPortable Oxygen Cylinder |
| Portable Oxygen Concentrator | Active comparator | Device: Portable OxygenPortable Oxygen Concentrator |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Outpatients diagnosed with stable COPD
- currently prescribed and using portable oxygen cylinders with a "pulsed" oxygen delivery for exertion.
Key exclusion criteria (2 listed)
- Co-morbidities such as: other major respiratory conditions, cardiac or other substantial co-morbidities which significantly limit mobility independent of COPD
- Baseline step test which demonstrates a reduced effect on the battery device compared to oxygen cylinders.
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 |
|---|---|---|
| Portable OxygenAlso: Respironics Airsep (rental) AssetNumber 38269 | Device | Portable Oxygen Concentrator, Portable Oxygen Cylinder |
Primary outcome
Quality of life as measured through Chronic Respiratory Questionnaire
Time frame: One month
only two subdomains of the Chronic Respiratory Questionnaire (CRQ) were used: the Shortness of Breath (SoB) domain and the Mastery domain
3 secondary outcomes
Patient Preference
Time frame: One month
Cost effectiveness of portable oxygen concentrator compared to cylinder
Time frame: one month
Quality of life as measured through AQoL-8D
Time frame: One month
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 10 Apr 2017.
- Individual participant dataSharing planned: Yes. IPD will be available upon request.
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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.
Brian J Smith, MBBS, FRACP, PhD principal investigator
The Queen Elizabeth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portable Oxygen in people with COPD, run by The Queen Elizabeth Hospital at 1 site in Australia.
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 2 inclusion and 2 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 10 Apr 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 Australia. 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.
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?
Quality of life as measured through Chronic Respiratory Questionnaire (time frame: One month). 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 10 Apr 2017.