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Trial registered on ANZCTR


Registration number
ACTRN12613000895785
Ethics application status
Approved
Date submitted
8/08/2013
Date registered
12/08/2013
Date last updated
12/08/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study to investigate the effects of one week of treatment with acetazolamide on the arterial levels of carbon dioxide in patients receiving non-invasive ventilation for the treatment of obesity hypoventilation syndrome
Scientific title
A pilot study to investigate the effects of one week of treatment with acetazolamide on the arterial levels of carbon dioxide in patients receiving non-invasive ventilation for the treatment of obesity hypoventilation syndrome
Secondary ID [1] 282903 0
nil known
Universal Trial Number (UTN)
U1111-1144-1469
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity hypoventilation syndrome 289717 0
Condition category
Condition code
Respiratory 290043 290043 0 0
Other respiratory disorders / diseases
Diet and Nutrition 290183 290183 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention will consist of treatment with oral acetazolamide tablets at a dose of 250mg twice a day for a period of one week. Compliance will be assessed by tablet count at the end of the week.
Intervention code [1] 287602 0
Treatment: Drugs
Comparator / control treatment
This is a pilot study and does not contain a control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290095 0
Level of arterial carbon dioxide (from arterial blood gas specimen mmHg)
Timepoint [1] 290095 0
one week and again at one month
Secondary outcome [1] 303928 0
ventilatory response to hypercapnia (slope of graph of minute ventilation against end tidal CO2)
Timepoint [1] 303928 0
at one week and again at one month

Eligibility
Key inclusion criteria
Diagnosis of obesity hypoventilation syndrome
Currently receiving non-invasive ventilation in s-mode
No hospitalisation with decompensation of respiratory failure for at least 3 months
Willing and able to give informed consent
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to provide informed consent
Poor renal function (eGFR <30ml/min)
Poor compliance with non-invasive ventilation (average usage less than 4 hours per night)
Allergy or previous adverse reaction to sulphur drugs
Use of supplemental oxygen
Any other safety concern at investigators discression

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All participants will receive the treatment in this pilot study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will not occur
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Paired t-test for values before and after treatment

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/08/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 5250 0
New Zealand
State/province [1] 5250 0

Funding & Sponsors
Funding source category [1] 287690 0
University
Name [1] 287690 0
University of otago, Wellington
Country [1] 287690 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Wellington
Address
University of Otago, Wellington
P.O.Box 7342
Wellington South
Wellington 6242
New Zealand
Country
New Zealand
Secondary sponsor category [1] 286423 0
None
Name [1] 286423 0
none
Address [1] 286423 0
none
Country [1] 286423 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289651 0
Central health and Disability Ethics Committee
Ethics committee address [1] 289651 0
1 The terrace
P.O. Box 5013
Wellington
6011
New Zealand
Ethics committee country [1] 289651 0
New Zealand
Date submitted for ethics approval [1] 289651 0
Approval date [1] 289651 0
29/07/2013
Ethics approval number [1] 289651 0
13/CEN/105

Summary
Brief summary
This study aims to investigate whether adding a medicine in pill form to the non-invasive ventilation that you are already receiving can make that non-invasive ventilation more successful.
This study aims to see whether adding acetazolamide to treatment with non-invasive ventilation can improve daytime hypercapnia by improving ventilatory response to hypercapnia. It will take subjects with a diagnosis of obesity hypoventilation syndrome who are already receiving treatment with non-invasive ventilation, but who still have abnormally high carbon dioxide levels despite that treatment.
They will have initial baseline measurements including arterial blood gas on air, renal function blood test and measurement of ventilatory response to hypercapnia. Providing their renal function is good enough they will then take acetazolamide at a dose of 250mg twice a day for one week. They will continue to use non-invasive ventilation at night throughout the study as normal. They will return at the end of that week for repeat arterial blood gas and ventilatory response to hypercapnia testing to see whether the acetazolamide has brought about any change. Further arterial blood gas and ventilatory response to hypercapnia testing will occur after one month to see whether any changes caused have persisted in the absence of the trial drug but with continued use of non-invasive ventilation.
This is a pilot study aiming to ensure the tolerability of this treatment and to quantify the magnitude of any changes seen. It would act to help inform a power calculation for a larger study should it be shown to be beneficial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41738 0
A/Prof Alister Neill
Address 41738 0
University of Otago Wellington
P.O Box 7342
Wellington South
Wellington
6242
Country 41738 0
New Zealand
Phone 41738 0
+64 043855999 ext 5618
Fax 41738 0
Email 41738 0
[email protected]
Contact person for public queries
Name 41739 0
James Pickering
Address 41739 0
Clinical Measurement Unit
Wellington Hospital
Private Bag 7902
Wellington
6242
Country 41739 0
New Zealand
Phone 41739 0
+64 04 3855999
Fax 41739 0
Email 41739 0
[email protected]
Contact person for scientific queries
Name 41740 0
James Pickering
Address 41740 0
Clinical Measurement Unit
Wellington Hospital
Private Bag 7902
Wellington
6242
Country 41740 0
New Zealand
Phone 41740 0
+64 04 3855999 bleep 2430
Fax 41740 0
Email 41740 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

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