Nebulised frusemide to imporve the sensation and unpleasant feeling of dyspnoea in patients with advanced diseases and breathlessness refractory to optimal standard management

Nebulised frusemide to improve the sensation and unpleasant feeling of dyspnoea in patients with advanced diseases and breathlessness refractory to optimal standard management

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000778886

Enrollment

Registered

2012-07-23

Start date

2012-09-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The trials is a open label case series study in which we will investigate the effect of nebulised frusemide on patients with advanced diseases and dyspnoea, refractory to current therapeutic modalities. We will administer 20-40mg of frusemide via a jet nebuliser twice daily over a 2 day period. Patients' levels of the sensation of breathlessness and the unpleasant feeling elicited will be measured by a modified BORG scale and HADS-A subscale.

Interventions

20mg-40mg of nebulised frusemide, i.e. one or two 20mg/2ml Sandoz ampoules without the addition of saline, delivered by a jet nebuliser. Dosage is determined clinically based on patient's concomitant disease status thus tolerability. The treatment can be given concurrently with pre-existing oxygen on the same rate (Litres/min). Each session of treatment will last no longer than 10 minutes.

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 No maximum

Healthy volunteers

Inclusion criteria

-Primary diagnosis of any irreversible disease. Prognosis of the disease needs to be less than 12 months. -Refractory dyspnoea that is not reponsive to more establisehd therapies. -Any concomitant disease but not rapidly deteriorating -Willingness to give informed consent documented by the treating team and willingness to participate and comply with the study

Exclusion criteria

-Unwilling/unable to give informed consent -Unable to tolerate frusemide -Rapid deterioration -Hepatic encephalopathy -Anuric renal failure -Mental or cognitive disorder, unable to reliably self-report or consent -Significant hypotension with the risk of further pronounced drop in blood pressure -Currently receiving risperidone -Significant history of gout -Significant change in medication that may affect dyspnoea within the last 24 hours -Hypersensitivity to frusemide or any inactive ingredient -Actively receiving treatment for dyspnoea, for example pleural effusion drainage or blood transfusion -Electrolyte disturbance -Aversion/inability to fit mask

Outcome results