None listed
Conditions
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.
Interventions
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.
Sponsors
University of Otago, Wellington
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Healthy volunteers
No
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
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
Outcome results
None listed