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Trial registered on ANZCTR


Registration number
ACTRN12612000778886
Ethics application status
Not yet submitted
Date submitted
20/07/2012
Date registered
23/07/2012
Date last updated
9/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Nebulised frusemide to imporve the sensation and unpleasant feeling of dyspnoea in patients with advanced diseases and breathlessness refractory to optimal standard management
Scientific title
Nebulised frusemide to improve the sensation and unpleasant feeling of dyspnoea in patients with advanced diseases and breathlessness refractory to optimal standard management
Secondary ID [1] 280872 0
Nil
Universal Trial Number (UTN)
U1111-1132-7746
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dyspnoea in advanced diseases 286942 0
Condition category
Condition code
Respiratory 287278 287278 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 285306 0
Treatment: Drugs
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287554 0
Change of the sensation of dyspnoea measured by a Modified BORG scale
Timepoint [1] 287554 0
30 minutes and 60 minutes after the initiation of treatment
Primary outcome [2] 287555 0
Change of the unpleasant feeling of dyspnoea measured by the anxiety section of a Hospital Anxiety and Depression Scale
Timepoint [2] 287555 0
At the end of each day during a 2 day treatment schedule
Secondary outcome [1] 298380 0
Nil
Timepoint [1] 298380 0
Nil

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5549 0
2050

Funding & Sponsors
Funding source category [1] 285656 0
Self funded/Unfunded
Name [1] 285656 0
Country [1] 285656 0
Primary sponsor type
Individual
Name
Dr Maria Cristina Cigolini
Address
Department of Palliative Care, Royal Prince Alfred Hospital, Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 284492 0
Hospital
Name [1] 284492 0
Royal Prince Alfred Hospital
Address [1] 284492 0
Missenden Road
Camperdown NSW 2050
Country [1] 284492 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287651 0
SLHD Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 287651 0
Mailing Address:
c/- Research Development Office
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050

Delivery Address:
Research Development Office
RPAH Medical Centre
Suite 210A, 100 Carillon Avenue
NEWTOWN NSW 2042
Ethics committee country [1] 287651 0
Australia
Date submitted for ethics approval [1] 287651 0
08/06/2012
Approval date [1] 287651 0
Ethics approval number [1] 287651 0
X12-0193 & HREC/12/RPAH/309

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34455 0
Address 34455 0
Country 34455 0
Phone 34455 0
Fax 34455 0
Email 34455 0
Contact person for public queries
Name 17702 0
Dr Maria Cristina Cigolini
Address 17702 0
Gloucester House 2, Department of Palliative medicine, Royal Prince Alfred Hospital, Missenden Rd, Camperdown, 2050 NSW
Country 17702 0
Australia
Phone 17702 0
+61 2 95157755
Fax 17702 0
+61 2 95157464
Email 17702 0
[email protected]
Contact person for scientific queries
Name 8630 0
Dr Maria Cristina Cigolini
Address 8630 0
Gloucester House 2, Department of Palliative medicine, Royal Prince Alfred Hospital, Missenden Rd, Camperdown, 2050 NSW
Country 8630 0
Australia
Phone 8630 0
+61 2 95157755
Fax 8630 0
+61 2 95157464
Email 8630 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
No additional documents have been identified.