Interstitial Lung DiseasePhase 2NCT01906931
Ambulatory Oxygen for ILD
A Phase 2 study testing Portable oxygen concentrator and Portable oxygen cylinder in people with Interstitial Lung Disease, run by Anne Holland at 1 site in Australia.
Trial summary
People with interstitial lung disease (ILD) are frequently prescribed ambulatory oxygen, to increase oxygen levels in the blood during daily activities. The best way of delivering this type of oxygen has not been established. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- Portable oxygen concentrator and Portable oxygen cylinder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2013to Feb 2014
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a confident diagnosis of ILD made according to established criteria and
- desaturate to less than 90% during a 6-minute walk test
Who cannot join
- primary diagnosis of a respiratory condition other than ILD (eg COPD)
- currently using continuous oxygen therapy
- oxyhaemoglobin saturation (SpO2) is less than 90% on room air
- unable to perform a 6-minute walk test or comorbidities that limit walking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effective Delivery of Ambulatory Oxygen in Interstitial Lung Disease - a Crossover Trial.
People with interstitial lung disease (ILD) are frequently prescribed ambulatory oxygen, to increase oxygen levels in the blood during daily activities. The best way of delivering this type of oxygen has not been established. The aim of this study is to compare two devices for delivering oxygen in people with interstitial lung disease - the traditional method using portable cylinders and a newer method using a portable concentrator. The investigators hypothesise that oxygen levels during exercise will be significantly higher when using a portable cylinder, but this difference will be small.
Read the detailed description
Exercise-induced hypoxaemia (EIA) is very common in individuals with ILD, due to progressive lung fibrosis which results in impaired gas exchange. It is common for people with EIA to be prescribed ambulatory oxygen, in order to normalize oxyhaemoglobin saturation, improve oxygen delivery to the tissues and relieve breathlessness during daily activities.
Ambulatory oxygen is traditionally delivered via a refillable portable oxygen cylinder containing compressed gaseous oxygen. More recently, portable oxygen concentrators (POCs) have emerged as a solution to the problem of finite cylinder life and to improve portability. Because a concentrator is constantly extracting oxygen from air, oxygen supply can continue as long as the battery is charged. This is typically around eight hours, but POCs can be recharged from an AC or DC power source. Portable oxygen concentrators usually weigh around 3.5kg, which is significantly lighter than oxygen cylinders, and are much easier to maneuver. However, there are some theoretical disadvantages to POCs. Like all concentrators, they do not deliver 100% oxygen. Concentrations typically range from 85-95%, depending on the flow rate. Differences in pulse timing and peak pulse flow between POCs may affect the fraction of inspired oxygen (FiO2) that is delivered. However, the clinical implications of these differences have not been documented.
The aim of this study is to compare the effects of ambulatory oxygen delivered during exercise using the EverGo POC to ambulatory oxygen delivered with a standard portable cylinder in individuals with ILD. We hypothesise that oxyhaemoglobin saturation during exercise will be significantly higher when using a portable cylinder, but this difference will not be clinically important.
- Conditions
- Interstitial Lung Disease
- Being tested
- Portable oxygen concentrator, Portable oxygen cylinder
- Keywords
- Interstitial lung disease, Oxygen therapy, Walk
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable oxygen concentratorDevice
Also called Respironics EverGo portable oxygen concentrator
Respironics EverGo portable oxygen concentrator on setting 6
Portable oxygen cylinderDevice
Portable oxygen cylinder at flow rate 5 Litres/min
| Study group | Role | What they receive |
|---|---|---|
| Portable Oxygen Concentrator first | Experimental | Not described Receives: Device: Portable oxygen concentrator; Device: Portable oxygen cylinder |
| Portable oxygen cylinder first | Active comparator | Not described Receives: Device: Portable oxygen concentrator; Device: Portable oxygen cylinder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nadir SpO2
Lowest SpO2 recorded during the 6-min walk test on each device
Measured: During 6-min walk test with each oxygen delivery device
Secondary outcomes (5)
6-min walk distance
The distance walked in 6 minutes with each oxygen delivery device will be compared
Measured: End 6-min walk test with each oxygen delivery device
Borg dyspnoea score
Borg dyspnoea score at the end of the 6-min walk test will be compared between devices
Measured: End 6-min walk test with each oxygen delivery device
Borg fatigue score
Borg fatigue score at the end of the 6-min walk test will be compared between devices
Measured: End 6-min walk test with each oxygen delivery device
Partial pressure of oxygen in arterial blood (PaO2) at rest
PaO2 at rest breathing oxygen from each of the two devices will be compared
Measured: Prior to 6-min walk test with each oxygen delivery device
Proportion of participants who desaturate to less than 80%
Proportion of participants who desaturate to less than 80% with each oxygen delivery device will be compared
Measured: During 6-min walk test on each oxygen delivery device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anne Holland
- Sponsor type
- University, hospital or other
- Collaborators
- The Alfred
- Responsible party
- Sponsor-investigator, Anne Holland, The Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906931
- Sponsor's protocol ID
- 187_13
- Status last verified
- Jun 2014
- First submitted
- 16 Jul 2013
- Last updated
- 25 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Delivery of Ambulatory Oxygen in Interstitial Lung Disease - a Crossover Trial.
- ClinicalTrials.gov ID
- NCT01906931
- Acronym / sponsor ID
- 187_13
- Conditions
- Interstitial Lung Disease
- Keywords
- Interstitial lung disease, Oxygen therapy, Walk
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Anne HollandUniversity, hospital or other
- Collaborators
- The Alfred
- Study start
- Aug 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 24 Jul 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.
People with interstitial lung disease (ILD) are frequently prescribed ambulatory oxygen, to increase oxygen levels in the blood during daily activities. The best way of delivering this type of oxygen has not been established. The aim of this study is to compare two devices for delivering oxygen in people with interstitial lung disease - the traditional method using portable cylinders and a newer method using a portable concentrator. The investigators hypothesise that oxygen levels during exercise will be significantly higher when using a portable cylinder, but this difference will be small.
Detailed description
Exercise-induced hypoxaemia (EIA) is very common in individuals with ILD, due to progressive lung fibrosis which results in impaired gas exchange. It is common for people with EIA to be prescribed ambulatory oxygen, in order to normalize oxyhaemoglobin saturation, improve oxygen delivery to the tissues and relieve breathlessness during daily activities.
Ambulatory oxygen is traditionally delivered via a refillable portable oxygen cylinder containing compressed gaseous oxygen. More recently, portable oxygen concentrators (POCs) have emerged as a solution to the problem of finite cylinder life and to improve portability. Because a concentrator is constantly extracting oxygen from air, oxygen supply can continue as long as the battery is charged. This is typically around eight hours, but POCs can be recharged from an AC or DC power source. Portable oxygen concentrators usually weigh around 3.5kg, which is significantly lighter than oxygen cylinders, and are much easier to maneuver. However, there are some theoretical disadvantages to POCs. Like all concentrators, they do not deliver 100% oxygen. Concentrations typically range from 85-95%, depending on the flow rate. Differences in pulse timing and peak pulse flow between POCs may affect the fraction of inspired oxygen (FiO2) that is delivered. However, the clinical implications of these differences have not been documented.
The aim of this study is to compare the effects of ambulatory oxygen delivered during exercise using the EverGo POC to ambulatory oxygen delivered with a standard portable cylinder in individuals with ILD. We hypothesise that oxyhaemoglobin saturation during exercise will be significantly higher when using a portable cylinder, but this difference will not be clinically important.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Portable Oxygen Concentrator first | Experimental | Device: Portable oxygen concentrator, Device: Portable oxygen cylinder |
| Portable oxygen cylinder first | Active comparator | Device: Portable oxygen concentrator, Device: Portable oxygen cylinder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- a confident diagnosis of ILD made according to established criteria and
- desaturate to less than 90% during a 6-minute walk test
Key exclusion criteria (4 listed)
- primary diagnosis of a respiratory condition other than ILD (eg COPD)
- currently using continuous oxygen therapy
- oxyhaemoglobin saturation (SpO2) is less than 90% on room air
- unable to perform a 6-minute walk test or comorbidities that limit walking
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 oxygen concentratorAlso: Respironics EverGo portable oxygen concentratorRespironics EverGo portable oxygen concentrator on setting 6 | Device | Portable Oxygen Concentrator first, Portable oxygen cylinder first |
| Portable oxygen cylinderPortable oxygen cylinder at flow rate 5 Litres/min | Device | Portable Oxygen Concentrator first, Portable oxygen cylinder first |
Primary outcome
Nadir SpO2
Time frame: During 6-min walk test with each oxygen delivery device
Lowest SpO2 recorded during the 6-min walk test on each device
5 secondary outcomes
6-min walk distance
Time frame: End 6-min walk test with each oxygen delivery device
Borg dyspnoea score
Time frame: End 6-min walk test with each oxygen delivery device
Borg fatigue score
Time frame: End 6-min walk test with each oxygen delivery device
Partial pressure of oxygen in arterial blood (PaO2) at rest
Time frame: Prior to 6-min walk test with each oxygen delivery device
Proportion of participants who desaturate to less than 80%
Time frame: During 6-min walk test on each oxygen delivery device
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 25 Jun 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Portable oxygen concentrator and Portable oxygen cylinder in people with Interstitial Lung Disease, run by Anne Holland 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 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 25 Jun 2014. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Nadir SpO2 (time frame: During 6-min walk test with each oxygen delivery device). 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 25 Jun 2014.