Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000457640
Ethics application status
Approved
Date submitted
6/09/2005
Date registered
22/09/2005
Date last updated
22/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of portable, exertional oxygen in chronic obstructive pulmonary disease.
Scientific title
A randomised, double-blinded, controlled trial to evaluate the effects of portable, exertional oxygen upon dyspnoea, quality of life and exercise tolerance in chronic obstructive pulmonary disease
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease 572 0
Condition category
Condition code
Respiratory 648 648 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects who have COPD but are not severely hypoxaemic at rest are randomised to receive either portable, compressed oxygen or portable compressed air to use during exertional activities for a period of 12 weeks.
Intervention code [1] 374 0
None
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 764 0
Dyspnoea
Timepoint [1] 764 0
At baseline, 4 weeks and 12 weeks
Primary outcome [2] 765 0
Quality of life
Timepoint [2] 765 0
At baseline, 4 weeks and 12 weeks
Primary outcome [3] 766 0
Exercise tolerance
Timepoint [3] 766 0
At baseline, 4 weeks and 12 weeks
Secondary outcome [1] 1556 0
Activity levels
Timepoint [1] 1556 0
At baseline, 4 weeks and 12 weeks.
Secondary outcome [2] 1557 0
Depression symptoms
Timepoint [2] 1557 0
At baseline, 4 weeks and 12 weeks.
Secondary outcome [3] 1558 0
Service utilisation
Timepoint [3] 1558 0
At baseline, 4 weeks and 12 weeks.

Eligibility
Key inclusion criteria
Diagnosis of chronic obstructive pulmonary disease, non-smoker, activity limited by breathlessness, clinically stable for previous 4 weeks, does not qualify for long term oxygen therapy (PaO2 > 55 mmHg), not currently receiving home oxygen therapy.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant locomotor disability, other severe disabling medical condition, currently attending a Pulmonary Rehabilitation Program.

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)
A computer-generated list of random numbers is used to allocate participants to the control or intervention group. Assignment to groups is undertaken by the supplier of the portable cylinders, and is thus concealed from the investigators.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation to the intervention or control group is undertaken on an odd or even number basis from a list of random numbers, which was computer-generated, using Microsoft Excel software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/05/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 708 0
Government body
Name [1] 708 0
National Health and Medical Research Council
Country [1] 708 0
Australia
Funding source category [2] 709 0
Hospital
Name [2] 709 0
The Northern Clinical Research Centre
Country [2] 709 0
Australia
Funding source category [3] 710 0
Charities/Societies/Foundations
Name [3] 710 0
The Austin Hospital Medical Research Foundation
Country [3] 710 0
Australia
Funding source category [4] 711 0
Commercial sector/Industry
Name [4] 711 0
Air Liquide Pty Limited
Country [4] 711 0
Funding source category [5] 712 0
Commercial sector/Industry
Name [5] 712 0
Boehringer Ingelheim Pty Limited
Country [5] 712 0
Australia
Primary sponsor type
Hospital
Name
The Northern Clinical Research Centre
Address
Country
Australia
Secondary sponsor category [1] 593 0
Hospital
Name [1] 593 0
Department of Respiratory Medicine, Austin Health
Address [1] 593 0
Country [1] 593 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1912 0
The Northern Hospital
Ethics committee address [1] 1912 0
Ethics committee country [1] 1912 0
Australia
Date submitted for ethics approval [1] 1912 0
Approval date [1] 1912 0
Ethics approval number [1] 1912 0
Ethics committee name [2] 1913 0
The Austin Hospital
Ethics committee address [2] 1913 0
Ethics committee country [2] 1913 0
Australia
Date submitted for ethics approval [2] 1913 0
Approval date [2] 1913 0
Ethics approval number [2] 1913 0

Summary
Brief summary
This project aims to investigate the effects of portable oxygen, used during activity, by people who have chronic obstructive pulmonary disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35672 0
Address 35672 0
Country 35672 0
Phone 35672 0
Fax 35672 0
Email 35672 0
Contact person for public queries
Name 9563 0
Rosemary Moore
Address 9563 0
Research Fellow
The Northern Clinical Research Centre
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country 9563 0
Australia
Phone 9563 0
+61 3 84058480
Fax 9563 0
+61 3 84058683
Email 9563 0
[email protected]
Contact person for scientific queries
Name 491 0
Associate Professor Christine McDonald
Address 491 0
Department of Respiratory Medicine
The Austin Hospital
Studley Road
Heidelberg VIC 3084
Country 491 0
Australia
Phone 491 0
+61 3 94965739
Fax 491 0
+61 3 94963723
Email 491 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.