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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01673685




Registration number
NCT01673685
Ethics application status
Date submitted
15/08/2012
Date registered
28/08/2012
Date last updated
10/04/2017

Titles & IDs
Public title
Trial of Portable Oxygen Cylinders Versus Battery Powered Portable Oxygen Concentrators
Scientific title
Randomised Crossover Trial of Portable Oxygen Cylinders Versus Battery Powered Portable Oxygen Concentrators
Secondary ID [1] 0 0
2010090
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Portable Oxygen

Placebo Comparator: Portable Oxygen Cylinder - Portable Oxygen Cylinder

Active Comparator: Portable Oxygen Concentrator - Portable Oxygen Concentrator


Treatment: Devices: Portable Oxygen
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Quality of life as measured through Chronic Respiratory Questionnaire
Timepoint [1] 0 0
One month
Secondary outcome [1] 0 0
Patient Preference
Timepoint [1] 0 0
One month
Secondary outcome [2] 0 0
Cost effectiveness of portable oxygen concentrator compared to cylinder
Timepoint [2] 0 0
one month
Secondary outcome [3] 0 0
Quality of life as measured through AQoL-8D
Timepoint [3] 0 0
One month

Eligibility
Key inclusion criteria
- Outpatients diagnosed with stable COPD

- currently prescribed and using portable oxygen cylinders with a "pulsed" oxygen
delivery for exertion.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Co-morbidities such as: other major respiratory conditions, cardiac or other
substantial co-morbidities which significantly limit mobility independent of COPD

- Baseline step test which demonstrates a reduced effect on the battery device compared
to oxygen cylinders.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
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
1/10/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2016
Sample size
Target
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
The Queen Elizabeth Hospital - Woodville Road, Woodville
Recruitment postcode(s) [1] 0 0
5022 - Woodville Road, Woodville

Funding & Sponsors
Primary sponsor type
Other
Name
The Queen Elizabeth Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Randomised cross-over study of portable oxygen concentrators compared to oxygen cylinders to
improve quality of life and other outcomes for patients with chronic obstructive pulmonary
disease.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01673685
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Brian J Smith, MBBS, FRACP, PhD
Address 0 0
The Queen Elizabeth Hospital
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01673685