Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000131459
Ethics application status
Approved
Date submitted
14/02/2007
Date registered
15/02/2007
Date last updated
13/03/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Oxygen therapy in severe asthma
Scientific title
A randomised controlled trial of the effect of high flow versus titrated oxygen therapy on carbon dioxide (CO2) levels in acute severe asthma
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute asthma 1623 0
Condition category
Condition code
Respiratory 1731 1731 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be randomly assigned to receive one of 2 oxygen regimes for 1 hour: Continuous high flow oxygen (8L/min via Hudson mask).
Intervention code [1] 1588 0
Treatment: Other
Comparator / control treatment
Patients will be randomly assigned to receive one of 2 oxygen regimes for 1 hour: variable flow oxygen titrated to achieve an oxygen saturation of 93-95% (nasal prongs or Hudson mask as required).
Control group
Active

Outcomes
Primary outcome [1] 2404 0
Proportion of patients with an increase in partial pressure of arterial carbon dioxide (PaCO2) greater than or equal to 4mmHg
Timepoint [1] 2404 0
At 1 hour
Secondary outcome [1] 4180 0
Proportion of patients with a partial pressure of arterial carbon dioxide (PaCO2) greater than or equal to 38mmHg or an increase of greater than or equal to 4mmHg
Timepoint [1] 4180 0
At 1 hour.
Secondary outcome [2] 4181 0
Changes in respiratory rate, heart rate and forced expiratory volume in 1 second (FEV1) as measured at baseline, 30minutes and 1hour.
Timepoint [2] 4181 0
Measured at baseline, 30minutes and 1hour.
Secondary outcome [3] 4182 0
Need for hospital admission at the end of the emergency department treatment period. The end of the emergency department treatment is variable as it depends on the patient and the severity of the condition, and therefore a time can not been specified.
Timepoint [3] 4182 0
The end of the emergency department treatment is variable as it depends on the patient and the severity of the condition, and therefore a time can not been specified.
Secondary outcome [4] 6627 0
Mean change in PaCO2
Timepoint [4] 6627 0
At time = 1 hour
Secondary outcome [5] 6628 0
Combined primary endpoint with oxygen and pneumonia study ANZCTR 12607000196448 measured as the proportion of patients with an increase in partial pressure of arterial carbon dioxide (PaCO2) greater than or equal to 4mmHg
Timepoint [5] 6628 0
Time = 1 hour

Eligibility
Key inclusion criteria
History of asthma; Presentation to the emergency department with an acute exacerbation of asthma; Forced expiratory volume in 1 second (FEV1) less than or equal to 50% predicted
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of Chronic obstructive pulmonary disease (COPD)/emphysema; Asthma attack requiring mechanical ventilation; Patient unconscious, unable to speak or unable to perform spirometry on arrival; Known or suspected chronic hypercapnic respiratory failure as a result of any of the following disorders - neuromuscular disease, chest wall disease, obesity hypoventilation syndrome.

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)
Subjects that consent and meet the study criteria will be enrolled onto the study and allocated a treatment by logging onto a secure website
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Third party randomisation will be used with random number sequences generated by a computer programme
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 481 0
New Zealand
State/province [1] 481 0

Funding & Sponsors
Funding source category [1] 1880 0
Government body
Name [1] 1880 0
Capital & Coast District Health Board
Country [1] 1880 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Medical Research Institute of New Zealand
Address
PO Box 10055
The Terrace
Welllington
Country
New Zealand
Secondary sponsor category [1] 1695 0
Government body
Name [1] 1695 0
Capital & Coast District Health Board
Address [1] 1695 0
Wellington Hospital
Riddiford Street
Newtown
Wellington
Country [1] 1695 0
New Zealand
Secondary sponsor category [2] 1696 0
Government body
Name [2] 1696 0
Health Research Council of New Zealand
Address [2] 1696 0
Level 3, 110 Stanley Street, Auckland, New Zealand
Country [2] 1696 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3505 0
Central Regional Ethics Committee
Ethics committee address [1] 3505 0
Ethics committee country [1] 3505 0
New Zealand
Date submitted for ethics approval [1] 3505 0
Approval date [1] 3505 0
18/01/2007
Ethics approval number [1] 3505 0
CEN/06/11/101

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

Contacts
Principal investigator
Name 27522 0
Address 27522 0
Country 27522 0
Phone 27522 0
Fax 27522 0
Email 27522 0
Contact person for public queries
Name 10777 0
Dr Kyle Perrin
Address 10777 0
Medical Research Institute of New Zealand
Level 3
99 The Terrace
Wellington
Country 10777 0
New Zealand
Phone 10777 0
+ 64 4 4729120
Fax 10777 0
Email 10777 0
[email protected]
Contact person for scientific queries
Name 1705 0
Dr Kyle Perrin
Address 1705 0
Medical Research Institute of New Zealand
Level 3
99 The Terrace
Wellington
Country 1705 0
New Zealand
Phone 1705 0
+ 64 4 4729120
Fax 1705 0
Email 1705 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
SourceTitleYear of PublicationDOI
Dimensions AIRandomised controlled trial of high concentration versus titrated oxygen therapy in severe exacerbations of asthma2011https://doi.org/10.1136/thx.2010.155259
N.B. These documents automatically identified may not have been verified by the study sponsor.