Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000484943
Ethics application status
Not yet submitted
Date submitted
29/03/2011
Date registered
10/05/2011
Date last updated
10/05/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised, placebo-controlled trial of glycopyrrolate for the treatment of noisy respiratory secretions at the end of life-A pilot study
Scientific title
A randomised, placebo-controlled trial of glycopyrrolate for the treatment of noisy respiratory secretions at the end of life-A pilot study
Secondary ID [1] 259879 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nosiy respiratory secretions at the end of life 265470 0
Condition category
Condition code
Cancer 265624 265624 0 0
Any cancer
Respiratory 265625 265625 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Glycopyrrolate 0.4mg initial subcutaneous dose immediately followed by continuous subcutaneous infusion of 1.2mg/24hours ( 0.05mg/hr) for a total of 24 hours.
Intervention code [1] 264302 0
Treatment: Drugs
Comparator / control treatment
Normal saline delivered via the same method.
Control group
Placebo

Outcomes
Primary outcome [1] 262408 0
Feasibilty measure by acrrual of 24 patients in 12 months
Timepoint [1] 262408 0
3 months
6 months
12 months
Secondary outcome [1] 273721 0
Interrater reliability of a Noisy respiratory secretions score (by two observers) and a noise meter.
Timepoint [1] 273721 0
Time points baseline, 30 minutes, 1 hour, 2 hours, 4 hours , 12 hours and 24 hours.

Eligibility
Key inclusion criteria
Age > 18 years
Life-limiting illness (malignant or non-malignant)
Inpatient in a Palliative Care unit
Able to provide informed consent prior to entering the terminal phase
Willing to discuss end of life care.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Documented hypersensitivity to glycopyrrolate.
Glaucoma
Pregnant or Breastfeeding
Estimated glomerular filtration rate (eGFR) < 25 ml/min

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)
central randomisation by phone /fax /computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 264760 0
Hospital
Name [1] 264760 0
Sacred Heart Reseach Fund
Country [1] 264760 0
Australia
Primary sponsor type
Individual
Name
Dr Caitlin Sheehan
Address
170 Darlinghurst Road
Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 263879 0
Individual
Name [1] 263879 0
Professor David Currow
Address [1] 263879 0
Flinders University
700 Goodwood Road
Daw Park SA 5041
Country [1] 263879 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 266738 0
St Vincents Hospital HREC
Ethics committee address [1] 266738 0
Victoria Street
Darlinghurst
NSW 2010
Ethics committee country [1] 266738 0
Australia
Date submitted for ethics approval [1] 266738 0
30/03/2011
Approval date [1] 266738 0
Ethics approval number [1] 266738 0

Summary
Brief summary
This study looks at the effect of a drug, called Glycopyrrolate, on noisy rattling breathing in palliative care patients at the end of life. Who is it for? You can join this study if you are an inpatient in a Palliative Care unit and are willing to discuss end of life care. Trial details Participants will be randomly divided into one of two groups. One group will receive a drug called Glycopyrrolate. This is administered via an injection followed by a continuous infusion (into the vein) for a duration of 24 hours . The other group will receive a placebo (sham) treatment also delivered in the same manner. The placebo has no expected treatment effect. Participants will not know which group they have been allocated to. This study aims to determine whether a larger scale trial of the drug, Glycopyrrolate, is feasible for the treatment of noisy rattling breathing at the end of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32406 0
Address 32406 0
Country 32406 0
Phone 32406 0
Fax 32406 0
Email 32406 0
Contact person for public queries
Name 15653 0
Dr Caitlin Sheehan
Address 15653 0
Sacred Heart Centre
St Vincents Hospital
170 Darlinghurst Road
Darlinghurst 2010
New South Wales
Country 15653 0
Australia
Phone 15653 0
+61 2 83829444
Fax 15653 0
Email 15653 0
[email protected]
Contact person for scientific queries
Name 6581 0
Dr Caitlin Sheehan
Address 6581 0
Sacred Heart Hospice
170 Darlinghurst Road
Darlinhghurst 2010
New South Wales
Country 6581 0
Australia
Phone 6581 0
+61 2 83829444
Fax 6581 0
Email 6581 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.