Pulmonary Disease, Chronic ObstructivePhase 3NCT02079753
Single Portable Pulse-dose-conserving Device vs. Combined Use of Stationary and Portable.
A Phase 3 study testing Inogen and Combination system of a portable and a stationary device. in people with Pulmonary Disease, Chronic Obstructive, run by Hospital Son Espases at 1 site in Spain.
Trial summary
Introduction: Portable oxygen devices simplify and facilitate patient therapy. This study was designed to compare oxygen saturation and patient satisfaction with a portable oxygen concentrator or with a combined system consisting of a fixed device with continuous flow oxygen dispensation and a portable device with… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Inogen and Combination system of a portable and a stationary device.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2011to Mar 2014
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 40-80 years
- had been diagnosed with COPD following the GOLD criteria
- were receiving oxygen therapy using a fixed oxygenation system and a portable system for ambulation
- without exacerbation during the previous month
- agreed to participate
Who cannot join
- terminally ill
- unable to understand Spanish
- had high oxygen flow at rest (> 3 lpm)
- high respiratory frequency at rest (> 32 rpm)
- were not achieving adequate O2 saturation levels during titration with the portable oxygen source
- had previously been diagnosed with obstructive sleep apnea hypopnea syndrome (SAHS)
- were receiving mechanical ventilation.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Servicio de Neumología. Hospital Clínico de San Carlos. Facultad de medicina. Universidad complutense de Madrid
Madrid, Madrid, 28040
About this study
Official title: Oxygenation Using a Single Portable Pulse-dose-conserving Device Compared to Combined Use of Stationary and Portable Oxygen Delivery Devices.
Introduction: Portable oxygen devices simplify and facilitate patient therapy. This study was designed to compare oxygen saturation and patient satisfaction with a portable oxygen concentrator or with a combined system consisting of a fixed device with continuous flow oxygen dispensation and a portable device with pulse dispensation for ambulation.
Methods: This cross-over trial assessed 25 patients with COPD (92% men; mean age 72.2 ± 7.4 years; mean FEV 34.14 ± 12.51%) at four hospitals in Madrid. All patients had previously used the combined system, consisting of a fixed oxygenation system and a portable system for ambulation, with 16 (64%) using stationary and portable concentrators and 9 (36%) using a stationary reservoir and portable liquid oxygen bag. Oxygenation settings at rest and while walking were determined at baseline. Patients were maintained on the previous combined system for one week and then switched to the portable oxygen concentrator for one week. Mean SpO2 over 24 hours was calculated by the software in the oximeter, and compliance was monitored
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Inogen, Combination system of a portable and a stationary device.
- Keywords
- COPD, portable concentrator, oxygen sources
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InogenDevice
single pulse dose concentrator (Inogen One G2 portable. Inogen) device for 24 hours
Combination system of a portable and a stationary device.Device
Combination system of a portable and a stationary device (reservoir of liquid oxygen "Liberator 30, Caire" and a liquid Stroller oxygen pack "Caire" for patients using previously liquid oxygen, or a VisionAire5 "Airsep" stationary concentrator and an Inogen One G2 portable "Inogen" concentrator for patients using previously concentrators)
| Study group | Role | What they receive |
|---|---|---|
| combined system | Active comparator | During the first visit, the technician installed a reservoir of liquid oxygen (Liberator 30, Caire) and a liquid Stroller oxygen pack (Caire) for patients using liquid oxygen, or a VisionAire5 (Airsep) stationary concentrator and an Inogen One G2 portable (Inogen) concentrator for patients using concentrators. Receives: Device: Combination system of a portable and a stationary device. |
| single system | Experimental | Inogen One G2 portable concentrator (Inogen) Receives: Device: Inogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time desaturated below 90% when using a combined oxygenation system
oxygenation of patient during use of a combined system consisting of a fixed device with continuous flow oxygen dispensation and a portable device with pulse dispensation for ambulation.
Measured: at day 7
Percentage of time desaturated below 90% using single oxygenation system
Oxygenation of patient during use of a portable oxygen pulse dose concentrator.
Measured: day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startJun 2011
- Primary completionFeb 2012
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Son Espases
- Sponsor type
- University, hospital or other
- Collaborators
- Linde AG
- Responsible party
- Principal investigator, Aina M Yañez, Hospital Son Espases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079753
- Sponsor's protocol ID
- POCs
- Status last verified
- Mar 2014
- First submitted
- 27 Feb 2014
- Last updated
- 6 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yanez AM, Prat JP, Alvarez-Sala JL, Calle M, Diaz Lobato S, Garcia Gonzalez JL, Rodriguez Gonzalez-Moro JM, Galera-Martinez R, Villasante C, Ramos I, Franco-Gay M, de Lucas P. Oxygenation With a Single Portable Pulse-Dose Oxygen-Conserving Device and Combined Stationary and Portable Oxygen Delivery Devices in Subjects With COPD. Respir Care. 2015 Mar;60(3):382-7. doi: 10.4187/respcare.03470. Epub 2014 Nov 25.
PubMed 25425710
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygenation Using a Single Portable Pulse-dose-conserving Device Compared to Combined Use of Stationary and Portable Oxygen Delivery Devices.
- ClinicalTrials.gov ID
- NCT02079753
- Acronym / sponsor ID
- POCs
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- COPD, portable concentrator, oxygen sources
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hospital Son EspasesUniversity, hospital or other
- Collaborators
- Linde AG
- Study start
- Jun 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 6 Mar 2014 (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.
Introduction: Portable oxygen devices simplify and facilitate patient therapy. This study was designed to compare oxygen saturation and patient satisfaction with a portable oxygen concentrator or with a combined system consisting of a fixed device with continuous flow oxygen dispensation and a portable device with pulse dispensation for ambulation.
Methods: This cross-over trial assessed 25 patients with COPD (92% men; mean age 72.2 ± 7.4 years; mean FEV 34.14 ± 12.51%) at four hospitals in Madrid. All patients had previously used the combined system, consisting of a fixed oxygenation system and a portable system for ambulation, with 16 (64%) using stationary and portable concentrators and 9 (36%) using a stationary reservoir and portable liquid oxygen bag. Oxygenation settings at rest and while walking were determined at baseline. Patients were maintained on the previous combined system for one week and then switched to the portable oxygen concentrator for one week. Mean SpO2 over 24 hours was calculated by the software in the oximeter, and compliance was monitored
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combined system | Active comparator | Device: Combination system of a portable and a stationary device.During the first visit, the technician installed a reservoir of liquid oxygen (Liberator 30, Caire) and a liquid Stroller oxygen pack (Caire) for patients using liquid oxygen, or a VisionAire5 (Airsep) stationary concentrator and an Inogen One G2 portable (Inogen) concentrator for patients using concentrators. |
| single system | Experimental | Device: InogenInogen One G2 portable concentrator (Inogen) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged 40-80 years
- had been diagnosed with COPD following the GOLD criteria
- were receiving oxygen therapy using a fixed oxygenation system and a portable system for ambulation
- without exacerbation during the previous month
- agreed to participate
Key exclusion criteria (7 listed)
- terminally ill
- unable to understand Spanish
- had high oxygen flow at rest (> 3 lpm)
- high respiratory frequency at rest (> 32 rpm)
- were not achieving adequate O2 saturation levels during titration with the portable oxygen source
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 |
|---|---|---|
| Inogensingle pulse dose concentrator (Inogen One G2 portable. Inogen) device for 24 hours | Device | single system |
| Combination system of a portable and a stationary device.Combination system of a portable and a stationary device (reservoir of liquid oxygen "Liberator 30, Caire" and a liquid Stroller oxygen pack "Caire" for patients using previously liquid oxygen, or a VisionAire5 "Airsep" stationary concentrator and an Inogen One G2 portable "Inogen" concentrator for patients using previously concentrators) | Device | combined system |
Primary outcome
Percentage of time desaturated below 90% when using a combined oxygenation system
Time frame: at day 7
oxygenation of patient during use of a combined system consisting of a fixed device with continuous flow oxygen dispensation and a portable device with pulse dispensation for ambulation.
Percentage of time desaturated below 90% using single oxygenation system
Time frame: day 14
Oxygenation of patient during use of a portable oxygen pulse dose concentrator.
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 6 Mar 2014.
- Derived from this study: PubMed 25425710Yanez AM, Prat JP, Alvarez-Sala JL, Calle M, Diaz Lobato S, Garcia Gonzalez JL, Rodriguez Gonzalez-Moro JM, Galera-Martinez R, Villasante C, Ramos I, Franco-Gay M, de Lucas P. Oxygenation With a Single Portable Pulse-Dose Oxygen-Conserving Device and Combined Stationary and Portable Oxygen Delivery Devices in Subjects With COPD. Respir Care. 2015 Mar;60(3):382-7. doi: 10.4187/respcare.03470. Epub 2014 Nov 25.
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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 3 study testing Inogen and Combination system of a portable and a stationary device. in people with Pulmonary Disease, Chronic Obstructive, run by Hospital Son Espases at 1 site in Spain.
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 5 inclusion and 7 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 6 Mar 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 Spain. 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 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?
Percentage of time desaturated below 90% when using a combined oxygenation system (time frame: at day 7). 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?
On the ClinicalTrials.gov record for NCT02079753, which also lists 1 linked publication.
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 6 Mar 2014.