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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618001848291
Ethics application status
Approved
Date submitted
8/11/2018
Date registered
14/11/2018
Date last updated
14/11/2018
Date data sharing statement initially provided
14/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of mode of inhaled salbutamol delivery on measures of small airways obstruction in asthma: a comparison of treatment delivered via spacer and nebuliser
Scientific title
The effect of mode of inhaled salbutamol delivery on measures of small airways obstruction in asthma: a comparison of treatment delivered via spacer and nebuliser
Secondary ID [1] 296553 0
None
Universal Trial Number (UTN)
U1111-1220-3693
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 310338 0
Condition category
Condition code
Respiratory 309070 309070 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One dose of inhaled salbutamol (1mg) given via metered-dose inhaler (with spacer) over 10 minutes and by nebuliser over 10 minutes on separate days and in random order. Treatment administered and observed by research staff during attendance at research unit. Washout between treatments a minimum of 24 hours.
Intervention code [1] 312862 0
Treatment: Drugs
Intervention code [2] 312887 0
Treatment: Devices
Comparator / control treatment
Inhaled salbutamol given via metered-dose inhaler
Control group
Active

Outcomes
Primary outcome [1] 308038 0
Change in small airways obstruction using impulse oscillometry measurement of R5-R20.
Timepoint [1] 308038 0
One timepoint within one hour after dosing.
Secondary outcome [1] 353788 0
Change in area of reactance measured by impulse oscillometry.
Timepoint [1] 353788 0
One timepoint within one hour after dosing.
Secondary outcome [2] 353858 0
Change in lung clearance index measured by multiple breath nitrogen washout.
Timepoint [2] 353858 0
One timepoint within one hour after dosing.
Secondary outcome [3] 353859 0
Change in Scond (index of ventilation heterogeneity in the conducting airways) measured by multiple breath nitrogen washout.
Timepoint [3] 353859 0
One timepoint within one hour after dosing.
Secondary outcome [4] 353860 0
Change in Sacin (index of ventilation heterogeneity in the acinar airways) measured by multiple breath nitrogen washout.
Timepoint [4] 353860 0
One timepoint within one hour after dosing.
Secondary outcome [5] 353861 0
Change in forced vital capacity measured by spirometry.
Timepoint [5] 353861 0
One timepoint within one hour after dosing.

Eligibility
Key inclusion criteria
Physician-diagnosed asthma requiring a minimum of treatment with regular inhaled corticosteroid
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Diagnosis of COPD, bronchiectasis, lung cancer.
• Other co-morbidity likely to affect study participation.
• Current smoker
• Poor asthma control (see 2016 NZ asthma guidelines for definition)
• Previous ICU admission for acute asthma

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)
Allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation of order of treatment by coin toss
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
This is a small pilot study of n=12 with no previous study done to power this study. Summary statistics will be provided for all patient characteristics of interest and all clinical measures. The changes in pre- and post-bronchodilator measurements will be reviewed to ascertain their distributions, and, given no indication that changes are non-normally distributed, compared with paired t-tests using untransformed data. Two-sided p values <0.05 will be considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21008 0
New Zealand
State/province [1] 21008 0

Funding & Sponsors
Funding source category [1] 301164 0
University
Name [1] 301164 0
University of Otago
Address [1] 301164 0
University of Otago
362 Leith Street
Dunedin
New Zealand
9054
Country [1] 301164 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
University of Otago
362 Leith Street
Dunedin
New Zealand
9054
Country
New Zealand
Secondary sponsor category [1] 300755 0
None
Name [1] 300755 0
None
Address [1] 300755 0
None
Country [1] 300755 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301884 0
Central Health and Disability Ethic Committee
Ethics committee address [1] 301884 0
Health and Disability Ethics Committees
Ministry of Health
113 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 301884 0
New Zealand
Date submitted for ethics approval [1] 301884 0
11/10/2018
Approval date [1] 301884 0
02/11/2018
Ethics approval number [1] 301884 0
18/CEN/209

Summary
Brief summary
This is a small study exploring the effect of the mode of delivery of salbutamol (inhaler vs. nebuliser) on the small airways of the lungs in patients with asthma. The effects of the two modes of delivery will be compared using measures of small airways disease from impulse oscillometry and multiple breath nitrogen washout. Asthma patients will attend two visits. At each visit, they will have these measures taken before and after bronchodilator therapy with salbutamol. At one visit, they will have nebulised salbutamol and at the other (in random) order, they will have salbutamol via metered-dose inhaler with spacer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88430 0
Dr Jack Dummer
Address 88430 0
Department of Medicine
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin
9054
Country 88430 0
New Zealand
Phone 88430 0
+64 34709362
Fax 88430 0
Email 88430 0
jack.dummer@otago.ac.nz
Contact person for public queries
Name 88431 0
Dr Jack Dummer
Address 88431 0
Department of Medicine
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin
9054
Country 88431 0
New Zealand
Phone 88431 0
+64 34709362
Fax 88431 0
Email 88431 0
jack.dummer@otago.ac.nz
Contact person for scientific queries
Name 88432 0
Dr Jack Dummer
Address 88432 0
Department of Medicine
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin
9054
Country 88432 0
New Zealand
Phone 88432 0
+64 34709362
Fax 88432 0
Email 88432 0
jack.dummer@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
If de-identified participant data is requested for publication we will make this available. If it is requested by a 3rd party we will give this consideration.
What supporting documents are/will be available?
No other documents available
Summary results
No Results