Condition category
Respiratory
Date applied
29/03/2005
Date assigned
10/05/2005
Last edited
07/10/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Amy Abernethy

ORCID ID

Contact details

Southern Adelaide Palliative Services
700 Goodwood Road
Daw Park
South Australia
5041
Australia
+61 8 8275 1732
amy.abernethy@duke.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00327873

Protocol/serial number

N/A

Study information

Scientific title

Acronym

02 Breathe

Study hypothesis

Oxygen therapy is superior to air in relieving the sensation of breathlessness in palliative care patients with intractable dyspnoea and PaO2 >55 mmHg
Null hypothesis: The provision of home oxygen in patients who do not meet the Australian national guidelines for domiciliary oxygen does not improve the subjective sensation of breathlessness.

Ethics approval

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Refractory dyspnea

Intervention

240 participants will be recruited through the palliative care, oncology, pulmonary, cardiology, and general medicine departments at five sites in Australia, two sites in the USA, and two sites in the UK. Participants will receive oxygen or medical air delivered at 2 liters per minute via concentrator and nasal cannulae. Participants are expected to use the treatment for more than 15 hours per day for 7 days. Concentrators will be delivered on the morning of Day 0 and retrieved on the morning of Day 7. Concentrator meters monitored by the company will provide evidence of gas delivery. Participants may continue all normal medications and treatments that they are receiving including physical therapy, exercise, change in position, inhaled treatments, and suctioning. Participants can receive new therapies during the study as would normally be prescribed by their treating doctors. Baseline examination will include medical diagnoses, smoking history, previous experience with oxygen, medications, vital signs, pulse oximetry, Karnofsky performance status, physical examination, resting PaO2, resting PaCO2, hemoglobin, and a description of the breathlessness. Participants will complete a study log twice a day for nine days (days -2 to 7) about the sensation of dyspnea using a 0-10 numeric rating scale (NRS) twice a day, sleep disturbance, breathlessness in the past 24 hours on the NRS, percentage relief of dyspnea, drowsiness, nasal irritation, performance status, vital signs, functional impact, and quality of life (QOL). Functional impact will be measured on the 4-point categorical Modified Medical Research Council of Great Britain (MRC) dyspnea scale and the Dyspnea Exertion Scale (DES).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

0-10 Numeric rating scale for dyspnoea.

Secondary outcome measures

1. McGill Quality of Life Questionnaire
2. Modified Medical Research Council Dyspnoea Scale
3. Dyspnoea Exertion Scale
4. Descriptors of dyspnoea
5. Verbal descriptor scales for nausea, drowsiness, nasal irritation, anxiety, patient preference
6. Costs of oxygen/air usage during and following participation

Overall trial start date

01/10/2004

Overall trial end date

30/06/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult patients with intractable dyspnea and PaO2 >55 mmHg 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.
2. Dyspnea can be at rest or with minimal exertion, as measured by a score of ≥3 on the Medical Research Council categorical dyspnea exertion scale
3. On stable medications over the prior week except routine 'as needed' medications
4. Prognosis of at least 1 month in the opinion of the treating physician

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

240

Participant exclusion criteria

1. Meets international guidelines for long-term oxygen therapy with PaO2 56-59 mmHg i.e. symptomatic pulmonary hypertension with cor pulmonale
2. Hemoglobin <10.0 g/dl as measured within one month of baseline evaluation
3. PaCO2 >50 mmHg
4. Confusion with Folstein Mini-mental Status Exam (MMSE) <24/30
5. Current oxygen therapy or continuous oxygen therapy in previous week
6. Actively smoking
7. Active respiratory or cardiac event in the previous 7 days, not including upper respiratory tract infections. Illness must be resolved for at least 7 days prior to baseline evaluation, as judged by a doctor involved in the care of the patient.
8. Previous respiratory failure induced by oxygen
9. Unable to give informed consent or complete diary entries

Recruitment start date

01/10/2004

Recruitment end date

30/06/2007

Locations

Countries of recruitment

Australia, United Kingdom, United States of America

Trial participating centre

Southern Adelaide Palliative Services
Daw Park, South Australia
5041
Australia

Sponsor information

Organisation

Repatriation General Hospital (Australia)

Sponsor details

Daws Road
Daw Park
South Australia
5041
Australia

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

National Health and Medical Research Council (Australia)

Alternative name(s)

NHMRC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Australia

Funder name

Cancer Council of Tasmania (Australia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Duke Institute for Care at the End of Life (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Doris Duke Charitable Foundation (USA)

Alternative name(s)

DDCF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20816546

Publication citations

  1. Results

    Abernethy AP, McDonald CF, Frith PA, Clark K, Herndon JE, 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, 376, 9743, 784-793, doi: 10.1016/S0140-6736(10)61115-4.

Additional files

Editorial Notes