Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000745044
Ethics application status
Approved
Date submitted
6/09/2010
Date registered
7/09/2010
Date last updated
15/02/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
How useful is spirometry during and following exacerbations of chronic obstructive pulmonary disease?
Scientific title
For patients admitted for a suspected exacerbation of chronic obstructive pulmonary disease (COPD), does use of spirometry compared with no spirometry influence diagnosis and management, and is it predictive of outcomes?
Secondary ID [1] 252634 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD exacerbations 258130 0
Condition category
Condition code
Respiratory 258311 258311 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Spirometry- once consented, the researcher will approach the patient at the bedside to perform spirometry with a hand-held portable spirometer and measure the usual values of forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), forced expiratory ratio (FER), inspiratory capacity (IC) etc. This will first occur within 24 hours of admission and then daily until discharge, and again at a 4 week follow-up. Testing should take around 30mins each time.
Intervention code [1] 257146 0
Diagnosis / Prognosis
Comparator / control treatment
Intention-to-treat, no additional testing will be done
Control group
Active

Outcomes
Primary outcome [1] 259155 0
Length of hopsital stay, determined by admission and discharge time
Timepoint [1] 259155 0
at discharge
Primary outcome [2] 259156 0
Change in initial diagnosis compared to discharge (final)diagnosis, determined from admission and discharge notes
Timepoint [2] 259156 0
admission and discharge
Primary outcome [3] 259157 0
treatment success or failure, success being discharge without futher complications and failure being need for mechanical ventilation and/or intensive care
Timepoint [3] 259157 0
at discharge or if treatment fails, at onset of mechanical ventilation/intensive care
Secondary outcome [1] 265482 0
differences in management, e.g. medications and referrals. between test and control groups, determined from medical records
Timepoint [1] 265482 0
at discharge and 4 week follow-up

Eligibility
Key inclusion criteria
current/ex smokers - 10 year pack history
hospital admission diagnosis of COPD exacerbation
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-english speaking
Confused/comatose/unable to follow instructions
Requiring mechanical ventilation/intensive care

Study design
Purpose of the study
Diagnosis
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 257599 0
University
Name [1] 257599 0
University of Melbourne
Country [1] 257599 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline (GSK)
Address
82 Hughes Avenue
Ermington, NSW 2115
Country
Australia
Secondary sponsor category [1] 256825 0
None
Name [1] 256825 0
Address [1] 256825 0
Country [1] 256825 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259620 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 259620 0
Ethics committee country [1] 259620 0
Australia
Date submitted for ethics approval [1] 259620 0
Approval date [1] 259620 0
01/09/2010
Ethics approval number [1] 259620 0
H2010/03972

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

Contacts
Principal investigator
Name 31607 0
Address 31607 0
Country 31607 0
Phone 31607 0
Fax 31607 0
Email 31607 0
Contact person for public queries
Name 14854 0
Bob Zhang
Address 14854 0
145 Studley Road
PO Box 5555
Heidelberg
Victoria 3084
Country 14854 0
Australia
Phone 14854 0
+61 3 94963720
Fax 14854 0
Email 14854 0
[email protected]
Contact person for scientific queries
Name 5782 0
Bob Zhang
Address 5782 0
145 Studley Road
PO Box 5555
Heidelberg
Victoria 3084
Country 5782 0
Australia
Phone 5782 0
+61 3 94963720
Fax 5782 0
Email 5782 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.