COPDBRVB-OCDNCT02627599
A Prospective Observational Study of the Breath Responsive Variable Bolus Oxygen Conserving Device
An observational study of COPD, run by StratiHealth at 3 sites in United States.
Trial summary
Evaluate subjects in an prospective observational study Subjects will be administered scientifically validated questionnaires Evaluate Quality Improvement and Oxygen Utilization Improvements. 1. Functional capability, dyspnea, oxygen saturation as primary endpoints 1. Baseline Dyspnea Index (BDI) 2. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- Breath Responsive Variable Bolus Oxygen Conserving Device
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2015to Nov 2016
- Phase
- Observational
- 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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Chronic Obstructive Pulmonary Disease
Who may be able to join
- Primary diagnosis of chronic obstructive pulmonary disease (COPD)
- Clinically stable disease at the time of consent
- Current prescription of oxygen 24 hours a day
- Previous or current oximetry desaturation at rest or activity (≤88% on one occasion)
- Highest measured FEV1, 70% predicted; and
- Highest measured FEV1/FVC, 70% predicted
Show all 11Show fewer
- Capable of giving informed consent
- Currently using a portable oxygen source that is a portable tank
- Mobility without a walker, cane or rollator
- Spo2 ≥ 90% on portable oxygen source at rest and activity
- Non-smoker at time of consent
Who cannot join
- Cardiovascular disease - New York Heart Association Functional Class III
- Degenerative bone or joint disease with limited functional ability
- Current homeless persons
- Active drug/alcohol dependence
- Recent drug or alcohol abuse history within the past two years
- Clinically unstable at the time of consent
- Currently a tobacco smoker
Trial locations and contacts
3 sites in 1 country.
United States3 sites
KP Oceanside Medical Office Building
Oceanside, California, 92054
Tcmc - Mob
Vista, California, 92054
Pathway Medical Group
Westminster, California, 92683
About this study
Official title: A Study to Evaluate Improvement in the Quality of Life and Health and Economic Outcomes of Patients Diagnosed With Chronic Obstructive Pulmonary Disease (COPD)
- Evaluate subjects in an prospective observational study
- Subjects will be administered scientifically validated questionnaires
- Evaluate Quality Improvement and Oxygen Utilization Improvements.
- Functional capability, dyspnea, oxygen saturation as primary endpoints
- Baseline Dyspnea Index (BDI)
- Transitional Dyspnea Index (TDI)
- Chronic Respiratory Disease Questionnaire (CRQ)
- Six minute walk distance (6MWD)
- Oxygen saturation using pulse oximeter
- The secondary endpoints:
- Portable oxygen source utilization
- Health care utilization (emergency room encounters, hospital admissions)
Read the detailed description
Evaluate subjects in an prospective observational study in which subjects will be screened and administered scientifically validated questionnaires at study entry and during the observation period at specified intervals to determine Quality Improvements through using the Breath Responsive Variable Bolus Oxygen Conserving Device with a Portable/Ambulatory Oxygen Source on improvements in functional capability, dyspnea, oxygen saturation, quality of life as primary endpoints, and portable oxygen source utilization, health care utilization as secondary endpoints.
- Conditions
- COPD
- Being tested
- Breath Responsive Variable Bolus Oxygen Conserving Device
- Keywords
- COPD, LTOT, Long-Term Oxygen Therapy, Oxygen Conserving Device, Quality of Life, Six Minute Walk Distance, Portable Oxygen Source, Oxygen Saturation, Breath Responsive Variable Bolus Oxygen Conserving Device, BRVB-OCD, Pulse Oximetry
- 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.
Breath Responsive Variable Bolus Oxygen Conserving DeviceDevice
Also called SmartDose®
Mini Electronic Oxygen Conserving Device
| Study group | Role | What they receive |
|---|---|---|
| Chronic Obstructive Pulmonary Disease | * More than 12 million adults are diagnosed with COPD
* COPD is the 3rd leading cause of death in the U.S.
* Breathing difficulty is the major reason patients seek medical attention
* COPD patients requiring hospitalization are associated with higher costs
* Oximetry is an important tool for assessing need for Long-Term Oxygen Therapy
* LTOT has been proven to improve survival and quality of life
* Patients provided with a breath responsive variable bolus oxygen conserving device:
1. support increased activity
2. improve quality of life
3. increase functional capability
4. reduce portable oxygen source utilization
5. maintain and/or improve oxygen saturation Receives: Device: Breath Responsive Variable Bolus Oxygen Conserving Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Dyspnea Index (BDI)
Baseline Functional Capability, Dyspnea as measured with the Baseline Dyspnea Index (BDI)
Measured: At baseline once upon entry into the study
Transition Dyspnea Index (TDI)
Improvement in Functional Capability, Dyspnea as measured with the Transition Dyspnea Index (TDI)
Measured: Every two weeks after baseline up to three months
Chronic Respiratory Disease Questionnaire (CRQ)
Improvement in Quality of Life as measured with the Chronic Respiratory Disease Questionnaire
Measured: At baseline upon study entry and change from baseline every two weeks up to three months
Oxygen Saturation
Assess pulse oximetry saturation at baseline on setting to maintain oxygen saturation equal to or greater than 90% at rest and with activity every two weeks to determine improvement or equivalence
Measured: At baseline upon study entry and change from baseline every two weeks up to three months
Six Minute Walk Distance
Assess distance covered in meters at baseline over 6 minutes and every two weeks up to three months to determine improvement in functional capability
Measured: At baseline upon study entry and change from baseline every two weeks up to three months
Secondary outcomes (2)
Portable Oxygen Source Utilization
Reduction in Portable Oxygen Source Use from baseline on enrollment with assessments of use each day throughout study period to determine if there are utilization reductions resulting in cost savings during study period.
Measured: 6 Months
Healthcare Utilization
Unscheduled Hospital, Emergency Room or Physician Office Visits, as measured from baseline 6 months prior to study entry and during study period to identify utilization changes if any.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startMay 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- StratiHealth
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kaiser Permanente, University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Isabel Pereira, MD, Principal investigator, StratiHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627599
- Sponsor's protocol ID
- 01012015DM
- Acronym
- BRVB-OCD
- Status last verified
- Aug 2018
- First submitted
- 24 Nov 2015
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Results will be submitted for publication in peer review
Publications
Gould GA, Scott W, Hayhurst MD, Flenley DC. Technical and clinical assessment of oxygen concentrators. Thorax. 1985 Nov;40(11):811-6. doi: 10.1136/thx.40.11.811.
PubMed 4071456Domingo C, Roig J, Coll R, Klamburg J, Izquierdo J, Ruiz-Manzano J, Morera J, Domingo E. Evaluation of the use of three different devices for nocturnal oxygen therapy in COPD patients. Respiration. 1996;63(4):230-5. doi: 10.1159/000196550.
PubMed 8815970NAUGHTON J, SEVELIUS G, BALKE B. PHYSIOLOGICAL RESPONSES OF NORMAL AND PATHOLOGICAL SUBJECTS TO A MODIFIED WORK CAPACITY TEST. J Sports Med Phys Fitness. 1963 Dec;3:201-7. No abstract available.
PubMed 14099069Hankinson JL, Odencrantz JR, Fedan KB. Spirometric reference values from a sample of the general U.S. population. Am J Respir Crit Care Med. 1999 Jan;159(1):179-87. doi: 10.1164/ajrccm.159.1.9712108.
PubMed 9872837Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
PubMed 16055882Carter R, Tashkin D, Djahed B, Hathaway E, Nicotra MB, Tiep BL. Demand oxygen delivery for patients with restrictive lung disease. Chest. 1989 Dec;96(6):1307-11. doi: 10.1378/chest.96.6.1307.
PubMed 2582836Rinow ME, Saltzman AR. Effectiveness of a new oxygen demand valve in chronic hypoxemia. Chest. 1986 Aug;90(2):204-7. doi: 10.1378/chest.90.2.204.
PubMed 3731892Tiep BL, Nicotra MB, Carter R, Phillips R, Otsap B. Low-concentration oxygen therapy via a demand oxygen delivery system. Chest. 1985 May;87(5):636-8. doi: 10.1378/chest.87.5.636.
PubMed 3921316Moore-Gillon JC, George RJ, Geddes DM. An oxygen conserving nasal cannula. Thorax. 1985 Nov;40(11):817-9. doi: 10.1136/thx.40.11.817.
PubMed 4071457Cranston JM, Crockett AJ, Moss JR, Alpers JH. Domiciliary oxygen for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2005 Oct 19;2005(4):CD001744. doi: 10.1002/14651858.CD001744.pub2.
PubMed 16235285Celli BR, MacNee W; ATS/ERS Task Force. Standards for the diagnosis and treatment of patients with COPD: a summary of the ATS/ERS position paper. Eur Respir J. 2004 Jun;23(6):932-46. doi: 10.1183/09031936.04.00014304. No abstract available.
PubMed 15219010Vestbo J, Hurd SS, Agusti AG, Jones PW, Vogelmeier C, Anzueto A, Barnes PJ, Fabbri LM, Martinez FJ, Nishimura M, Stockley RA, Sin DD, Rodriguez-Roisin R. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013 Feb 15;187(4):347-65. doi: 10.1164/rccm.201204-0596PP. Epub 2012 Aug 9.
PubMed 22878278Strickland SL, Hogan TM, Hogan RG, Sohal HS, McKenzie WN, Petroski GF. A randomized multi-arm repeated-measures prospective study of several modalities of portable oxygen delivery during assessment of functional exercise capacity. Respir Care. 2009 Mar;54(3):344-9.
PubMed 19245728Fuhrman C, Chouaid C, Herigault R, Housset B, Adnot S. Comparison of four demand oxygen delivery systems at rest and during exercise for chronic obstructive pulmonary disease. Respir Med. 2004 Oct;98(10):938-44. doi: 10.1016/j.rmed.2004.03.010.
PubMed 15481269Langenhof S, Fichter J. Comparison of two demand oxygen delivery devices for administration of oxygen in COPD. Chest. 2005 Oct;128(4):2082-7. doi: 10.1378/chest.128.4.2082.
PubMed 16236858
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Improvement in the Quality of Life and Health and Economic Outcomes of Patients Diagnosed With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT02627599
- Acronym / sponsor ID
- BRVB-OCD / 01012015DM
- Conditions
- COPD
- Keywords
- COPD, LTOT, Long-Term Oxygen Therapy, Oxygen Conserving Device, Quality of Life, Six Minute Walk Distance, Portable Oxygen Source, Oxygen Saturation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- StratiHealthIndustry (pharma, biotech, devices)
- Collaborators
- Kaiser Permanente, University of Pennsylvania
- Study start
- May 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 11 Dec 2015 (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.
- Evaluate subjects in an prospective observational study
- Subjects will be administered scientifically validated questionnaires
- Evaluate Quality Improvement and Oxygen Utilization Improvements.
- Functional capability, dyspnea, oxygen saturation as primary endpoints
- Baseline Dyspnea Index (BDI)
- Transitional Dyspnea Index (TDI)
- Chronic Respiratory Disease Questionnaire (CRQ)
- Six minute walk distance (6MWD)
- Oxygen saturation using pulse oximeter
- The secondary endpoints:
- Portable oxygen source utilization
- Health care utilization (emergency room encounters, hospital admissions)
Detailed description
Evaluate subjects in an prospective observational study in which subjects will be screened and administered scientifically validated questionnaires at study entry and during the observation period at specified intervals to determine Quality Improvements through using the Breath Responsive Variable Bolus Oxygen Conserving Device with a Portable/Ambulatory Oxygen Source on improvements in functional capability, dyspnea, oxygen saturation, quality of life as primary endpoints, and portable oxygen source utilization, health care utilization as secondary endpoints.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Obstructive Pulmonary Disease | – | Device: Breath Responsive Variable Bolus Oxygen Conserving Device* More than 12 million adults are diagnosed with COPD * COPD is the 3rd leading cause of death in the U.S. * Breathing difficulty is the major reason patients seek medical attention * COPD patients requiring hospitalization are associated with higher costs * Oximetry is an important tool for assessing need for Long-Term Oxygen Therapy * LTOT has been proven to improve survival and quality of life * Patients provided with a breath responsive variable bolus oxygen conserving device: 1. support increased activity 2. improve quality of life 3. increase functional capability 4. reduce portable oxygen source utilization 5. maintain and/or improve oxygen saturation |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Chronic Obstructive Pulmonary Disease
Key inclusion criteria (11 listed)
- Primary diagnosis of chronic obstructive pulmonary disease (COPD)
- Clinically stable disease at the time of consent
- Current prescription of oxygen 24 hours a day
- Previous or current oximetry desaturation at rest or activity (≤88% on one occasion)
- Highest measured FEV1, 70% predicted; and
Key exclusion criteria (7 listed)
- Cardiovascular disease - New York Heart Association Functional Class III
- Degenerative bone or joint disease with limited functional ability
- Current homeless persons
- Active drug/alcohol dependence
- Recent drug or alcohol abuse history within the past two years
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 |
|---|---|---|
| Breath Responsive Variable Bolus Oxygen Conserving DeviceAlso: SmartDose®Mini Electronic Oxygen Conserving Device | Device | Chronic Obstructive Pulmonary Disease |
Primary outcome
Baseline Dyspnea Index (BDI)
Time frame: At baseline once upon entry into the study
Baseline Functional Capability, Dyspnea as measured with the Baseline Dyspnea Index (BDI)
Transition Dyspnea Index (TDI)
Time frame: Every two weeks after baseline up to three months
Improvement in Functional Capability, Dyspnea as measured with the Transition Dyspnea Index (TDI)
Chronic Respiratory Disease Questionnaire (CRQ)
Time frame: At baseline upon study entry and change from baseline every two weeks up to three months
Improvement in Quality of Life as measured with the Chronic Respiratory Disease Questionnaire
Oxygen Saturation
Time frame: At baseline upon study entry and change from baseline every two weeks up to three months
Assess pulse oximetry saturation at baseline on setting to maintain oxygen saturation equal to or greater than 90% at rest and with activity every two weeks to determine improvement or equivalence
Six Minute Walk Distance
Time frame: At baseline upon study entry and change from baseline every two weeks up to three months
Assess distance covered in meters at baseline over 6 minutes and every two weeks up to three months to determine improvement in functional capability
2 secondary outcomes
Portable Oxygen Source Utilization
Time frame: 6 Months
Healthcare Utilization
Time frame: 6 Months
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 15 Aug 2018.
- Background: PubMed 4071456Gould GA, Scott W, Hayhurst MD, Flenley DC. Technical and clinical assessment of oxygen concentrators. Thorax. 1985 Nov;40(11):811-6. doi: 10.1136/thx.40.11.811.
- Background: PubMed 8815970Domingo C, Roig J, Coll R, Klamburg J, Izquierdo J, Ruiz-Manzano J, Morera J, Domingo E. Evaluation of the use of three different devices for nocturnal oxygen therapy in COPD patients. Respiration. 1996;63(4):230-5. doi: 10.1159/000196550.
- Background: PubMed 14099069NAUGHTON J, SEVELIUS G, BALKE B. PHYSIOLOGICAL RESPONSES OF NORMAL AND PATHOLOGICAL SUBJECTS TO A MODIFIED WORK CAPACITY TEST. J Sports Med Phys Fitness. 1963 Dec;3:201-7. No abstract available.
- Background: PubMed 9872837Hankinson JL, Odencrantz JR, Fedan KB. Spirometric reference values from a sample of the general U.S. population. Am J Respir Crit Care Med. 1999 Jan;159(1):179-87. doi: 10.1164/ajrccm.159.1.9712108.
- Background: PubMed 16055882Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
- Background: PubMed 2582836Carter R, Tashkin D, Djahed B, Hathaway E, Nicotra MB, Tiep BL. Demand oxygen delivery for patients with restrictive lung disease. Chest. 1989 Dec;96(6):1307-11. doi: 10.1378/chest.96.6.1307.
- Background: PubMed 3731892Rinow ME, Saltzman AR. Effectiveness of a new oxygen demand valve in chronic hypoxemia. Chest. 1986 Aug;90(2):204-7. doi: 10.1378/chest.90.2.204.
- Background: PubMed 3921316Tiep BL, Nicotra MB, Carter R, Phillips R, Otsap B. Low-concentration oxygen therapy via a demand oxygen delivery system. Chest. 1985 May;87(5):636-8. doi: 10.1378/chest.87.5.636.
- Background: PubMed 4071457Moore-Gillon JC, George RJ, Geddes DM. An oxygen conserving nasal cannula. Thorax. 1985 Nov;40(11):817-9. doi: 10.1136/thx.40.11.817.
- Results publication: PubMed 16235285Cranston JM, Crockett AJ, Moss JR, Alpers JH. Domiciliary oxygen for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2005 Oct 19;2005(4):CD001744. doi: 10.1002/14651858.CD001744.pub2.
- Results publication: PubMed 15219010Celli BR, MacNee W; ATS/ERS Task Force. Standards for the diagnosis and treatment of patients with COPD: a summary of the ATS/ERS position paper. Eur Respir J. 2004 Jun;23(6):932-46. doi: 10.1183/09031936.04.00014304. No abstract available.
- Results publication: PubMed 22878278Vestbo J, Hurd SS, Agusti AG, Jones PW, Vogelmeier C, Anzueto A, Barnes PJ, Fabbri LM, Martinez FJ, Nishimura M, Stockley RA, Sin DD, Rodriguez-Roisin R. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013 Feb 15;187(4):347-65. doi: 10.1164/rccm.201204-0596PP. Epub 2012 Aug 9.
- Individual participant dataSharing planned: No. Results will be submitted for publication in peer review
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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.
Isabel Pereira, MD principal investigator
StratiHealth
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by StratiHealth at 3 sites in United States.
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 11 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 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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.
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?
Baseline Dyspnea Index (BDI) (time frame: At baseline once upon entry into the study). The study lists 5 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 NCT02627599, which also lists 36 linked publications.
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 15 Aug 2018.