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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00327873




Registration number
NCT00327873
Ethics application status
Date submitted
18/05/2006
Date registered
19/05/2006
Date last updated
14/12/2009

Titles & IDs
Public title
Palliative Oxygen for the Relief of Breathlessness
Scientific 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
Secondary ID [1] 0 0
AG0064
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dyspnea 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Oxygen
Other interventions - Medical Air

Experimental: A - Oxygen

Active comparator: B - Medical Air


Other interventions: Oxygen
2L/min for 15 hours or greater per day via concentrator and nasal cannulae for 7 days

Other interventions: Medical Air
2L/min for 15 hours or greater per day via concentrator and nasal cannulae for 7 days
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Changes in relief from the sensation of breathlessness
Timepoint [1] 0 0
7 days
Secondary outcome [1] 0 0
Changes in quality of life (QOL)
Timepoint [1] 0 0
7 days
Secondary outcome [2] 0 0
Identification of patients who benefit from palliative oxygen
Timepoint [2] 0 0
7 days
Secondary outcome [3] 0 0
Identification of side effects
Timepoint [3] 0 0
7 days
Secondary outcome [4] 0 0
Documentation of costs of palliative oxygen
Timepoint [4] 0 0
7 days

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2008
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC
Recruitment hospital [1] 0 0
Sydney Area Health Service, Sydney Cancer Centre - Sydney
Recruitment hospital [2] 0 0
Flinders University, Southern Adelaide Palliative Services - Adelaide
Recruitment hospital [3] 0 0
Statewide Palliative Care Service - Launceston
Recruitment hospital [4] 0 0
Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Sydney
Recruitment postcode(s) [2] 0 0
5041 - Adelaide
Recruitment postcode(s) [3] 0 0
7250 - Launceston
Recruitment postcode(s) [4] 0 0
3084 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
North Carolina
Country [2] 0 0
United Kingdom
State/province [2] 0 0
Cambridge
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Other
Name
National Health and Medical Research Council, Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Doris Duke Charitable Foundation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Cancer Council Tasmania
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Duke Institute on Care at the End of Life, USA
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Flinders Medical Research Institute Small Research Grants Scheme, Australia
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Amy Abernethy, MD
Address 0 0
Duke University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00327873