DyspneaNCT00327873
Palliative Oxygen for the Relief of Breathlessness
A study testing Oxygen and Medical Air in people with Dyspnea, run by National Health and Medical Research Council, Australia at 7 sites in 3 countries.
Trial summary
The main goal of this study is to establish the effectiveness of palliative oxygen in the context within which it is usually provided--relief of the sensation of breathlessness and improvement in quality of life for people with maximally-treated life-limiting illness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea
- What is being tested?
- Oxygen and Medical Air
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 7 sitesin 3 countries
- Study dates
- May 2005to Mar 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with intractable dyspnea and PaO2>55mmHg in the setting of terminal illness where the underlying cause has been maximally treated; a medical specialist must document that all identified reversible causes of the dyspnea have been treated; PaO2 measurement must be in the last month
- Dyspnea at rest or with minimal exertion, as measured by a score of ≥ 3 on the Medical Research Council categorical dyspnea exertion scale
- On stable medications over the prior week except routine "as needed" medications.
- Survival of at least 1 month in the opinion of the treating physician
Who cannot join
- Meets international guidelines for long-term oxygen therapy with PaO2 56-59mmHg, i.e. symptomatic pulmonary hypertension with cor pulmonale
- Hemoglobin<10.0g/dL as measured within one month of baseline evaluation
- PaCO2 >50 mm Hg.
- Confusion as measured by Folstein Mini-mental Status Exam <24/30
- Current oxygen therapy or continuous oxygen therapy in previous week
- Actively smoking
Show all 9Show fewer
- Active respiratory or cardiac event in the previous 2 weeks, not including upper respiratory tract infections; illness must be resolved for at least 2 weeks prior to baseline evaluation, as judged by a doctor involved in the care of the patient
- Previous respiratory failure induced by oxygen
- Unable to give informed consent or complete diary entries
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Australia4 sites
Flinders University, Southern Adelaide Palliative Services
Adelaide, South Australia, 5041
Statewide Palliative Care Service
Launceston, Tasmania, 7250
Austin Health
Melbourne, Victoria, 3084
Sydney Area Health Service, Sydney Cancer Centre
Sydney, New South Wales, 2050
United Kingdom2 sites
St Nicholas Hospice
Cambridge, Cambridge, IP33 2QY UK
Nottingham University
Nottingham, Nottingham, NG5 1PB
United States1 site
Duke University Department of Medicine, Division of Medical Oncology
Durham, North Carolina, 27710
About this study
Official title: A Multi-center Randomized Double-blind Controlled Trial of Oxygen Versus Medical Air for the Relief of Breathlessness in Patients With Intractable Dyspnea and PaO2>55mmHg
The main goal of this study is to establish the effectiveness of palliative oxygen in the context within which it is usually provided--relief of the sensation of breathlessness and improvement in quality of life for people with maximally-treated life-limiting illness.
Read the detailed description
When further medical management will not relieve intractable breathlessness, palliative oxygen is often prescribed regardless of whether the person meets the common oxygen funding criteria of severely low blood oxygen levels. The results of this study will inform best practice in the care of people with advanced life-limiting illness and intractable breathlessness, aid in the development of rational funding guidelines, and answer an international debate on the role of palliative oxygen.
This study is a definitive international multi-center randomized double-blind controlled trial of oxygen versus medical air for the relief of breathlessness in participants with intractable dyspnea and PaO2>55mmHg (a measure of blood oxygen levels). Specific aims include demonstration of the effectiveness of oxygen versus medical air in relieving breathlessness in the palliative setting (Specific Aim 1) and improving QOL (Specific Aim 2). Additionally, we will seek to establish which patients derive the greatest benefit (Specific Aim 3), the risks of therapy (Specific Aim 4), and the costs of therapy (Specific Aim 5). The primary hypothesis is that oxygen therapy is superior to air in relieving the sensation of breathlessness for patients with intractable dyspnea due to life-limiting illness in the setting of PaO2>55mmHg.
All participants are enrolled as outpatients. The "eligibility visit" occurs about 5-7 days before starting the study and will include review of the consent form, a short interview, physical exam, and blood tests. The visit can occur in the home or clinic. The blood tests include regular venipuncture and also an arterial blood gas, if these studies have not been done in the preceding month. The "randomization visit" occurs 2 days before the study starts (Day -2) and includes a short interview and quality of life (QOL) questionnaire; this visit is usually done in the home but can also occur in the clinic. The oxygen or air concentrators are delivered to the home on Day 0 by a trained person from the oxygen company. On the same day there is also a brief home visit from the study nurse that includes a short interview and QOL questionnaire. The participant uses the oxygen or medical air gas each of 7 days (Days 0-6) for at least 15 hours each day. While using the oxygen/air the participant fills out a short diary form in the morning and evening, within 30 minutes of waking up or retiring. The diary focuses on the breathlessness, how the participant is feeling, and potential side effects of the gas. The study nurse conducts a "check-in" telephone call on Day 3 to make sure the participant is doing OK. On the last day (Day 6) the nurse visits the home to conduct a brief interview with a short QOL questionnaire. The oxygen company will pick up the concentrator, usually on Day 7.
- Conditions
- Dyspnea
- Being tested
- Oxygen, Medical Air
- Keywords
- breathlessness, shortness of breath, end-of-life care, hospice
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenOther
2L/min for 15 hours or greater per day via concentrator and nasal cannulae for 7 days
Medical AirOther
2L/min for 15 hours or greater per day via concentrator and nasal cannulae for 7 days
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Oxygen Receives: Other: Oxygen |
| B | Active comparator | Medical Air Receives: Other: Medical Air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in relief from the sensation of breathlessness
Measured: 7 days
Secondary outcomes (4)
Changes in quality of life (QOL)
Measured: 7 days
Identification of patients who benefit from palliative oxygen
Measured: 7 days
Identification of side effects
Measured: 7 days
Documentation of costs of palliative oxygen
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2006 (estimated)
- Study startMay 2005
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DyspneaStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Health and Medical Research Council, Australia
- Sponsor type
- University, hospital or other
- Collaborators
- Doris Duke Charitable Foundation, Cancer Council Tasmania, Duke Institute on Care at the End of Life, USA, Flinders Medical Research Institute Small Research Grants Scheme, Australia
- Investigators
- Amy Abernethy, MD, Principal investigator, Duke UniversityDavid Curow, BMed,FRACP,MPH, Principal investigator, Flinders University, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00327873
- Sponsor's protocol ID
- AG0064
- Status last verified
- Feb 2009
- First submitted
- 18 May 2006
- Last updated
- 14 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Abernethy AP, Currow DC, Frith P, Fazekas B. Prescribing palliative oxygen: a clinician survey of expected benefit and patterns of use. Palliat Med. 2005 Mar;19(2):168-70. doi: 10.1177/026921630501900219. No abstract available.
PubMed 15810762Booth S, Wade R, Johnson M, Kite S, Swannick M, Anderson H; Expert Working Group of the Scientific Committee of the Association of Palliative Medicine. The use of oxygen in the palliation of breathlessness. A report of the expert working group of the Scientific Committee of the Association of Palliative Medicine. Respir Med. 2004 Jan;98(1):66-77. doi: 10.1016/j.rmed.2003.08.008.
PubMed 14959816Guyatt GH, McKim DA, Austin P, Bryan R, Norgren J, Weaver B, Goldstein RS. Appropriateness of domiciliary oxygen delivery. Chest. 2000 Nov;118(5):1303-8. doi: 10.1378/chest.118.5.1303.
PubMed 11083678Bruera E, Sweeney C, Willey J, Palmer JL, Strasser F, Morice RC, Pisters K. A randomized controlled trial of supplemental oxygen versus air in cancer patients with dyspnea. Palliat Med. 2003 Dec;17(8):659-63. doi: 10.1191/0269216303pm826oa.
PubMed 14694916Abernethy AP, McDonald CF, Frith PA, Clark K, Herndon JE 2nd, Marcello J, Young IH, Bull J, Wilcock A, Booth S, Wheeler JL, Tulsky JA, Crockett AJ, Currow DC. Effect of palliative oxygen versus room air in relief of breathlessness in patients with refractory dyspnoea: a double-blind, randomised controlled trial. Lancet. 2010 Sep 4;376(9743):784-93. doi: 10.1016/S0140-6736(10)61115-4.
PubMed 20816546
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Randomized Double-blind Controlled Trial of Oxygen Versus Medical Air for the Relief of Breathlessness in Patients With Intractable Dyspnea and PaO2>55mmHg
- ClinicalTrials.gov ID
- NCT00327873
- Acronym / sponsor ID
- AG0064
- Conditions
- Dyspnea
- Keywords
- breathlessness, shortness of breath, end-of-life care, hospice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- National Health and Medical Research Council, AustraliaUniversity, hospital or other
- Collaborators
- Doris Duke Charitable Foundation, Cancer Council Tasmania, Duke Institute on Care at the End of Life, USA, Flinders Medical Research Institute Small Research Grants Scheme, Australia
- Study start
- May 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 19 May 2006 (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.
The main goal of this study is to establish the effectiveness of palliative oxygen in the context within which it is usually provided--relief of the sensation of breathlessness and improvement in quality of life for people with maximally-treated life-limiting illness.
Detailed description
When further medical management will not relieve intractable breathlessness, palliative oxygen is often prescribed regardless of whether the person meets the common oxygen funding criteria of severely low blood oxygen levels. The results of this study will inform best practice in the care of people with advanced life-limiting illness and intractable breathlessness, aid in the development of rational funding guidelines, and answer an international debate on the role of palliative oxygen.
This study is a definitive international multi-center randomized double-blind controlled trial of oxygen versus medical air for the relief of breathlessness in participants with intractable dyspnea and PaO2>55mmHg (a measure of blood oxygen levels). Specific aims include demonstration of the effectiveness of oxygen versus medical air in relieving breathlessness in the palliative setting (Specific Aim 1) and improving QOL (Specific Aim 2). Additionally, we will seek to establish which patients derive the greatest benefit (Specific Aim 3), the risks of therapy (Specific Aim 4), and the costs of therapy (Specific Aim 5). The primary hypothesis is that oxygen therapy is superior to air in relieving the sensation of breathlessness for patients with intractable dyspnea due to life-limiting illness in the setting of PaO2>55mmHg.
All participants are enrolled as outpatients. The "eligibility visit" occurs about 5-7 days before starting the study and will include review of the consent form, a short interview, physical exam, and blood tests. The visit can occur in the home or clinic. The blood tests include regular venipuncture and also an arterial blood gas, if these studies have not been done in the preceding month. The "randomization visit" occurs 2 days before the study starts (Day -2) and includes a short interview and quality of life (QOL) questionnaire; this visit is usually done in the home but can also occur in the clinic. The oxygen or air concentrators are delivered to the home on Day 0 by a trained person from the oxygen company. On the same day there is also a brief home visit from the study nurse that includes a short interview and QOL questionnaire. The participant uses the oxygen or medical air gas each of 7 days (Days 0-6) for at least 15 hours each day. While using the oxygen/air the participant fills out a short diary form in the morning and evening, within 30 minutes of waking up or retiring. The diary focuses on the breathlessness, how the participant is feeling, and potential side effects of the gas. The study nurse conducts a "check-in" telephone call on Day 3 to make sure the participant is doing OK. On the last day (Day 6) the nurse visits the home to conduct a brief interview with a short QOL questionnaire. The oxygen company will pick up the concentrator, usually on Day 7.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: OxygenOxygen |
| B | Active comparator | Other: Medical AirMedical Air |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients with intractable dyspnea and PaO2>55mmHg in the setting of terminal illness where the underlying cause has been maximally treated; a medical specialist must document that all identified reversible causes of the dyspnea have been treated; PaO2 measurement must be in the last month
- Dyspnea at rest or with minimal exertion, as measured by a score of ≥ 3 on the Medical Research Council categorical dyspnea exertion scale
- On stable medications over the prior week except routine "as needed" medications.
- Survival of at least 1 month in the opinion of the treating physician
Key exclusion criteria (9 listed)
- Meets international guidelines for long-term oxygen therapy with PaO2 56-59mmHg, i.e. symptomatic pulmonary hypertension with cor pulmonale
- Hemoglobin<10.0g/dL as measured within one month of baseline evaluation
- PaCO2 >50 mm Hg.
- Confusion as measured by Folstein Mini-mental Status Exam <24/30
- Current oxygen therapy or continuous oxygen therapy in previous week
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 |
|---|---|---|
| Oxygen2L/min for 15 hours or greater per day via concentrator and nasal cannulae for 7 days | Other | A |
| Medical Air2L/min for 15 hours or greater per day via concentrator and nasal cannulae for 7 days | Other | B |
Primary outcome
Changes in relief from the sensation of breathlessness
Time frame: 7 days
4 secondary outcomes
Changes in quality of life (QOL)
Time frame: 7 days
Identification of patients who benefit from palliative oxygen
Time frame: 7 days
Identification of side effects
Time frame: 7 days
Documentation of costs of palliative oxygen
Time frame: 7 days
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 14 Dec 2009.
- Background: PubMed 15810762Abernethy AP, Currow DC, Frith P, Fazekas B. Prescribing palliative oxygen: a clinician survey of expected benefit and patterns of use. Palliat Med. 2005 Mar;19(2):168-70. doi: 10.1177/026921630501900219. No abstract available.
- Background: PubMed 14959816Booth S, Wade R, Johnson M, Kite S, Swannick M, Anderson H; Expert Working Group of the Scientific Committee of the Association of Palliative Medicine. The use of oxygen in the palliation of breathlessness. A report of the expert working group of the Scientific Committee of the Association of Palliative Medicine. Respir Med. 2004 Jan;98(1):66-77. doi: 10.1016/j.rmed.2003.08.008.
- Background: PubMed 11083678Guyatt GH, McKim DA, Austin P, Bryan R, Norgren J, Weaver B, Goldstein RS. Appropriateness of domiciliary oxygen delivery. Chest. 2000 Nov;118(5):1303-8. doi: 10.1378/chest.118.5.1303.
- Background: PubMed 14694916Bruera E, Sweeney C, Willey J, Palmer JL, Strasser F, Morice RC, Pisters K. A randomized controlled trial of supplemental oxygen versus air in cancer patients with dyspnea. Palliat Med. 2003 Dec;17(8):659-63. doi: 10.1191/0269216303pm826oa.
- Derived from this study: PubMed 20816546Abernethy AP, McDonald CF, Frith PA, Clark K, Herndon JE 2nd, Marcello J, Young IH, Bull J, Wilcock A, Booth S, Wheeler JL, Tulsky JA, Crockett AJ, Currow DC. Effect of palliative oxygen versus room air in relief of breathlessness in patients with refractory dyspnoea: a double-blind, randomised controlled trial. Lancet. 2010 Sep 4;376(9743):784-93. doi: 10.1016/S0140-6736(10)61115-4.
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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.
Amy Abernethy, MD principal investigator
Duke University
David Curow, BMed,FRACP,MPH principal investigator
Flinders University, Australia
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen and Medical Air in people with Dyspnea, run by National Health and Medical Research Council, Australia at 7 sites in 3 countries.
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 4 inclusion and 9 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 14 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia, United Kingdom, 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?
Changes in relief from the sensation of breathlessness (time frame: 7 days). 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 NCT00327873, which also lists 5 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 14 Dec 2009; AzTrials last refreshed its copy on 7 Nov 2026.