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Trial registered on ANZCTR


Registration number
ACTRN12619001032145p
Ethics application status
Submitted, not yet approved
Date submitted
1/05/2019
Date registered
18/07/2019
Date last updated
18/07/2019
Date data sharing statement initially provided
18/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of nebulised furosemide on breathlessness and cough in interstitial lung disease: a pilot study
Scientific title
Effect of nebulised furosemide on breathlessness and cough in interstitial lung disease: a pilot study
Secondary ID [1] 298087 0
Nil
Universal Trial Number (UTN)
U1111-1232-5016
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Interstitial Lung Disease 312598 0
Condition category
Condition code
Respiratory 311108 311108 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This pilot study will seek to recruit volunteers with interstitial lung disease (ILD) experiencing significant cough and dyspnoea. These volunteers will be administered a single dose of nebulised furosemide (80mg) in the context of exercise induced dyspnoea, with a dose of nebulised normal saline of equivalent milliliters being used as a control. The order of the administration of these nebulised agents will be randomised, and both participants and researchers will be blinded to nebulised agent order. The nebulised agents will be administered by a study doctor (these are medical registrars, advanced trainees in respiratory medicine or respiratory specialists) immediately prior to exercise, i.e. exercise testing will commence immediately after completion of nebulised agent administration. This will take place in either the outpatient clinic or respiratory function testing laboratory of the John Hunter Hospital. The exercise testing referred to is the 6 minute walk test (6MWT). The 6MWT is a exercise testing tool developed by the American thoracic society, which is used both clinically and in research to assess functional exercise capacity. As the name implies, the test assesses the distance which a participant can walk over a 6 minute period.
The second nebulised agent will be given a minimum of 3 days after the first to allow a sufficient wash out period.
The response of the participants’ cough and dyspnoea to the administration of both nebulised furosemide and normal saline will be recorded and compared.
Intervention code [1] 314317 0
Treatment: Drugs
Comparator / control treatment
Nebulised normal saline (8ml) will be used as a control
Control group
Placebo

Outcomes
Primary outcome [1] 319884 0
The primary dyspnoea end point will be the area under the curve for Borg scores in the first 5 minutes after the 6 minute walk test.
Timepoint [1] 319884 0
Area under the curve of Borg scores 5 minutes following walk test. Note that Borg scores will be taken every 30 seconds for the first 5 minutes after the 6 minute walk test is completed.
Primary outcome [2] 320729 0
The primary cough end point will be the area under the curve for cough VAS scores in the 6.5 hours after the 6 minute walk test
Timepoint [2] 320729 0
Area under the curve for cough VAS score in the 6.5 hours after the 6 minute walk test. Note cough VAS will be recorded immediately after completion of 6MWT, then 30 minutes after completion of the 6 minute walk test, then hourly for 6 hours.
Secondary outcome [1] 369781 0
Area under the curve of dyspnoea visual analogue scores for a variety of time points
Timepoint [1] 369781 0
Over 6.5 hours following 6 minute walk test. Note that Dyspnoea visual analogue scores will be taken every 30 seconds for the first 5 minutes after the 6 minute walk test, every 1 minute for the next 10 minutes, then every 5 minutes for the next 15 minutes. Thereafter, the visual analogue score will be recorded every 1 hour for 6 hours.
Secondary outcome [2] 369839 0
Area under the curve of Borg scores for a variety of time points
Timepoint [2] 369839 0
Over 30 minutes following the 6 minute walk test. Scores will be taken every 30 seconds for the first 5 minutes after the 6 minute walk test, every 1 minute for the next 10 minutes, then every 5 minutes for the next 15 minutes.
Secondary outcome [3] 369840 0
Area under the curve for cough visual analogue scores for a variety of time points
Timepoint [3] 369840 0
For 6.5 hours after 6 minute walk test. A cough visual analogue score is taken 30 minutes after completion of the 6 minute walk test, then every 1 hour for 6 hours.
Secondary outcome [4] 369841 0
Cough monitor scores
Timepoint [4] 369841 0
For 6.5 hours after 6 minute walk test. The cough monitor is worn and recording continuously over this 6.5 hour period to record participants' coughing. The number of times the participant coughs over this 6.5 hour period can then be counted using the recording obtained.

Eligibility
Key inclusion criteria
Age > 18 years
Confirmed physician diagnosis of an interstitial lung disease
Medical research council dyspnoea scale of 3-5
Cough visual analogue scale >4cm
FVC >=30% predicted
DLCO >=20% predicted
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current smoker
Clinical history of asthma or vocal cord dysfunction
Currently pregnant or breastfeeding
Any clinically significant cardiopulmonary abnormalities not related to ILD, including features of congestive cardiac failure on examination or history suggestive of uncontrolled ischaemic heart disease.
Any clinically significant neurological, renal, endocrine, gastrointestinal, hepatic or haematological abnormalities uncontrolled with standard treatment
History of psychiatric, medical or surgical disorders that may interfere with study
Clinical history suggestive of respiratory infection in month preceding study
Alcohol or recreational drug abuse
Inability to understand directions for study assessment, including inability to comprehend English language.
Inability to complete questionnaires required for the study, including visual analogue scales.
Inability to be contacted in case of emergency
Participation in another study at the same time or within a prior 3-month period
Regular use of short or long-acting opioids, pregabalin or gabapentin.
Inability to complete a 6 minute walk test
Allergy or significant adverse reaction to furosemide

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 computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Note that this study is a pilot study only, therefore is only recruiting 12 participants. A sample size of 12 participants was chosen based upon the work by Julious, which demonstrates that 12 is the optimal number of participants for a pilot cross-over trial for both feasibility and for gains in precision in the mean and variance. The data from the 12 participants in the pilot study will be used to inform a formal sample size calculation for any future study.
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary end point and secondary end points will be evaluated as paired non parametric data for statistical analysis using the Wilcoxan signed rank test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/08/2019
Actual
Date of last participant enrolment
Anticipated
5/08/2020
Actual
Date of last data collection
Anticipated
10/08/2020
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13661 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 26343 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 302617 0
Charities/Societies/Foundations
Name [1] 302617 0
John Hunter Hospital Respiratory Trust Fund
Country [1] 302617 0
Australia
Primary sponsor type
Hospital
Name
Hunter New England Health
Address
c/o Chair of Human Ethics Committee, John Hunter Hospital, Lookout Road, New Lambton Heights, NSW, Australia, 2305
Country
Australia
Secondary sponsor category [1] 302530 0
None
Name [1] 302530 0
Address [1] 302530 0
Country [1] 302530 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303250 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 303250 0
Ethics committee country [1] 303250 0
Australia
Date submitted for ethics approval [1] 303250 0
01/05/2019
Approval date [1] 303250 0
Ethics approval number [1] 303250 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93010 0
A/Prof Christopher Grainge
Address 93010 0
Dept Respiratory Medicine, John Hunter Hospital, Lookout Road, New Lambton Heights, NSW, Australia, 2305
Country 93010 0
Australia
Phone 93010 0
+61 2 49855043
Fax 93010 0
Email 93010 0
christopher.grainge@health.nsw.gov.au
Contact person for public queries
Name 93011 0
Christopher Grainge
Address 93011 0
Dept Respiratory Medicine, John Hunter Hospital, Lookout Road, New Lambton Heights, NSW, Australia. 2305
Country 93011 0
Australia
Phone 93011 0
+61 2 49855043
Fax 93011 0
Email 93011 0
christopher.grainge@health.nsw.gov.au
Contact person for scientific queries
Name 93012 0
Christopher Grainge
Address 93012 0
Dept Respiratory Medicine, John Hunter Hospital, Lookout Road, New Lambton Heights. NSW, Australia, 2305
Country 93012 0
Australia
Phone 93012 0
+61 2 49855043
Fax 93012 0
Email 93012 0
christopher.grainge@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only, will be shared after de-identification
When will data be available (start and end dates)?
Start date of IPD availability: 6 months after last patient visit
End date of IPD availability: No end date
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
for discussion on case by case basis
How or where can data be obtained?
access subject to approvals by Principal Investigator, requirement to sign data access agreement


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1971Study protocol    377488-(Uploaded-15-07-2019-15-57-00)-Study-related document.doc
1972Informed consent form    377488-(Uploaded-15-07-2019-15-11-10)-Study-related document.docx



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.