Chronic Obstructive Pulmonary DiseaseNCT00546299
Gas Usage for Those With COPD Who Experience Low Oxygen Levels During Activities Only
A study testing oxygen in people with Chronic Obstructive Pulmonary Disease, run by West Park Healthcare Centre.
Trial summary
Several studies have described the use of supplemental oxygen during exertion or activities of daily living (ambulatory oxygen) in study populations that have different characteristics. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- oxygen
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Feb 2003to Dec 2005
- 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 Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of COPD
- dyspnea limiting daily activities
- desaturation less than or equal to 88% for 2 continuous minutes during a room air six-minute walk test
Who cannot join
- less than or equal to 18 years old
- those who met criteria for mortality reduction with long-term oxygen
- those who received oxygen for palliative care or isolated nocturnal hypoxemia
- those unable to complete the questionnaires or provide informed consent
About this study
Official title: Ambulatory Gas Usage in Patients With COPD and Exertional Hypoxemia
Several studies have described the use of supplemental oxygen during exertion or activities of daily living (ambulatory oxygen) in study populations that have different characteristics. This report, based on specialized randomized controlled trials, characterizes ambulatory gas usage among patients with COPD who experience low oxygen levels during activities.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- oxygen
- Keywords
- Ambulatory oxygen therapy, COPD, exertional hypoxemia
- 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.
oxygenDrug
cylinder and concentrator, dosage to maintain SpO2 above 92%, used during exertion
What is being measured
The primary outcome is the main question the study is designed to answer.
gas usage
Measured: 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2007 (estimated)
- Study startFeb 2003
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Park Healthcare Centre
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, McMaster University, Ontario Ministry of Health and Long Term Care
- Investigators
- Roger Goldstein, MD, Study director, Respiratory Rehabilitation, West Park Healthcare Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00546299
- Sponsor's protocol ID
- 8-42361
- Status last verified
- Oct 2007
- First submitted
- 17 Oct 2007
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulatory Gas Usage in Patients With COPD and Exertional Hypoxemia
- ClinicalTrials.gov ID
- NCT00546299
- Acronym / sponsor ID
- 8-42361
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Ambulatory oxygen therapy, COPD, exertional hypoxemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- West Park Healthcare CentreUniversity, hospital or other
- Collaborators
- University of Toronto, McMaster University, Ontario Ministry of Health and Long Term Care
- Study start
- Feb 2003
- Study completion
- Dec 2005 (actual)
- First posted
- 18 Oct 2007 (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.
Several studies have described the use of supplemental oxygen during exertion or activities of daily living (ambulatory oxygen) in study populations that have different characteristics. This report, based on specialized randomized controlled trials, characterizes ambulatory gas usage among patients with COPD who experience low oxygen levels during activities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of COPD
- dyspnea limiting daily activities
- desaturation less than or equal to 88% for 2 continuous minutes during a room air six-minute walk test
Key exclusion criteria (4 listed)
- less than or equal to 18 years old
- those who met criteria for mortality reduction with long-term oxygen
- those who received oxygen for palliative care or isolated nocturnal hypoxemia
- those unable to complete the questionnaires or provide informed consent
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 |
|---|---|---|
| oxygencylinder and concentrator, dosage to maintain SpO2 above 92%, used during exertion | Drug | – |
Primary outcome
gas usage
Time frame: 2
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 30 Apr 2024.
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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.
Roger Goldstein, MD study director
Respiratory Rehabilitation, West Park Healthcare Centre
Questions about this trial
What is this clinical trial studying?
A study testing oxygen in people with Chronic Obstructive Pulmonary Disease, run by West Park Healthcare Centre.
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 3 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 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
gas usage (time frame: 2). 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 30 Apr 2024.