Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000080022
Ethics application status
Not yet submitted
Date submitted
12/01/2010
Date registered
22/01/2010
Date last updated
22/01/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised trial of air and oxygen driven nebulised salbutamol and ipratropium in Chronic Obstructive Pulmonary Disease (COPD).
Scientific title
A randomised placebo crossover trial to compare the effects of nebulised salbutamol and ipratropium driven by air and oxygen on transcutaneous crabon dioxide (CO2) levels in patients with severe Chronic Obstructive Pulmonary Disease (COPD).
Secondary ID [1] 1317 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD 256512 0
Condition category
Condition code
Respiratory 256680 256680 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will attend on 2 separate days. On each day they will receive a nebuliser containing 5mg of salbutamol and 500mcg of ipratropium bromide followed after 5 minutes by another nebuliser containg 5mg salbutamol only. On 1 day the nebuliser will be driven by air and on the other day by 8L of oxygen. Patients attend on 2 seperate days so washout period will be at least 24 hours.
Intervention code [1] 255791 0
Treatment: Drugs
Comparator / control treatment
Each subject will receive the nebulisers driven by air and oxygen as described above. Subjects will act as their own comparators
Control group
Active

Outcomes
Primary outcome [1] 257568 0
Change in transcutaneous CO2 level (tCO2). Assessed by use of TOSCA machine. Please not TOSCA is a tradename not an acronym.
Timepoint [1] 257568 0
T=35 minutes. Following administration of second nebuliser.
Secondary outcome [1] 262814 0
Number of patients experiencing a rise in tCO2 >10mmHg and clinical symptoms; defined as a fall in Glasgow Coma Score (GCS) of 1 point or a fall in Abbreviated Mental Test Score (AMT) <7/10.
Timepoint [1] 262814 0
T= 35 minutes. Following administration of second nebuliser.

Eligibility
Key inclusion criteria
Diagnosis of COPD according to British Thoracic Society (BTS) criteria
Pre-bronchodilator forced expiratory volume in 1 second (FEV1) less than or equal to 40% of predicted
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of allergy/sensitivity to study drugs
On warfarin
Concurrent risk factors for hypercapnic respiratory failure (Body Mass Index >40, chest wall restriction, severe musculoskeletal weakness)
Those needing >4L oxygen via nasal cannulae to keep saturations >88%

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)
Patients will be recruited from home oxygen database. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
They will be allocated to the order of either air or oxygen driven nebuliser according to a randomisation sequence obtained by our staistician using a randomisation table created by computer software Subjects and investigators will not however be blinded to the allocation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment outside Australia
Country [1] 2399 0
New Zealand
State/province [1] 2399 0

Funding & Sponsors
Funding source category [1] 256280 0
Charities/Societies/Foundations
Name [1] 256280 0
Medical Research Institute of New Zealand
Country [1] 256280 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Medical Research Institute of New Zealand (MRINZ)
Address
PO Box 10055, 3rd Floor, 99 The Terrace,
Wellington 6143
Country
New Zealand
Secondary sponsor category [1] 251604 0
None
Name [1] 251604 0
Address [1] 251604 0
Country [1] 251604 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258370 0
Central Regional Ethics Committee
Ethics committee address [1] 258370 0
Po Box 5013
Wellington 6145
Ethics committee country [1] 258370 0
New Zealand
Date submitted for ethics approval [1] 258370 0
19/11/2009
Approval date [1] 258370 0
Ethics approval number [1] 258370 0
CEN/09/12/093

Summary
Brief summary
Patients with COPD are sensitive to the effects of oxygen, especially so those who are on oxygen at home. When these patients suffer an exacerbation they are frequently given nebulisers in the anbulance whilst in transit to hospital. Nebulisers are often driven by oxygen, sometimes large amounts. On long journeys they may be given multiple nebulisations with high flows of oxygen. Our hypothesis is that this may increase CO2 to dangerous levels whereby patients are at risk of develeoping an altered state of conciousness. We aim to compare different flows of oxygen given with nebulisers to assess what effect this has on the CO2 of patients with COPD.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30685 0
Address 30685 0
Country 30685 0
Phone 30685 0
Fax 30685 0
Email 30685 0
Contact person for public queries
Name 13932 0
Llifon Edwards
Address 13932 0
MRINZ, PO Box 10055, 3rd Floor, 99 The Terrace, Wellington 6143
Country 13932 0
New Zealand
Phone 13932 0
0064 4 4729199
Fax 13932 0
0064 4 4729224
Email 13932 0
[email protected]
Contact person for scientific queries
Name 4860 0
Llifon Edwards
Address 4860 0
MRINZ, PO Box 10055, 3rd Floor, 99 The Terrace, Wellington 6143
Country 4860 0
New Zealand
Phone 4860 0
0064 4 4729199
Fax 4860 0
0064 4 4729224
Email 4860 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
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