Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001066279
Ethics application status
Approved
Date submitted
9/12/2009
Date registered
11/12/2009
Date last updated
19/11/2018
Date data sharing statement initially provided
19/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Inhaled mannitol for the clearance of mucus in asthma
Scientific title
Inhaled mannitol for the treatment of mucociliary dysfunction in patients with asthma - Its effect and mechanisms on the clearance of mucus
Secondary ID [1] 1191 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 252356 0
Condition category
Condition code
Respiratory 256545 256545 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study consisted of 5 visits. The first visit was a screening visit involving assessment of lung function and a bronchial challenge with mannitol after premedication with eformoterol. Subjects were eligible to proceed to the next visits if they had a fall in forced expiratory volume in one second (FEV1) less than 15 % from the baseline value.

Visits 2-5 were mucociliary and cough clearance studies using a radioaerosol technique and imaging with a gamma camera in the Departmet of Nuclear Medicine. The radioaerosol inhaled was sulphur colloid tagged with technetium.
Mucocilairy and cough clearance was measured over a total of 90 min at baseline (no cough or mannitol) and in response to 2 doses of inhaled dry powder mannitol (240 and 480 mg). Patients were premedicated with eformoterol at all times prior to inhaling mannitol. The baseline and mannitol visits were randomised. The last visit was a cough control day involving cough but no mannitol.
Cough clearance was assessed by asking the subjects to cough, 30 minutes after mannitol inhalation, 100 times (4 per min) over 30 minutes.
Intervention code [1] 255664 0
Treatment: Drugs
Comparator / control treatment
uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 253425 0
an improvement in mucociliary and cough clearance of mucus measured with the imaging technique. Image analysis gives counts over time that are used to calculate clearance of mucus over time.
Timepoint [1] 253425 0
acute effect of total of 90 min measured in each visit
Secondary outcome [1] 262543 0
acute improvement in the physical properties of sputum as a result of interventions.
Sputum is collected at the beginning (baseline) and end of each visit for the measurement of the physical properties. The physical properties include the solids content, surface tension, rheology and contact angle. An improvement in the physical properties is a significant reduction in the physical properties at the end of each visit compared to the baseline measurements.
Timepoint [1] 262543 0
over 90 min on each visit

Eligibility
Key inclusion criteria
asthma
chronic cough and sputum production
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
fall in FEV1 greater or equal to 15% in response to mannitol
bronchiectasis based on high resolution computed tomography (HRCT)

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)
The order of the mucociliary clearance studies at baseline and with the two doses of mannitol (visits 2-4) were randomised using the randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/02/2008
Actual
11/02/2008
Date of last participant enrolment
Anticipated
Actual
25/07/2008
Date of last data collection
Anticipated
Actual
7/08/2008
Sample size
Target
10
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256148 0
Government body
Name [1] 256148 0
National Health and Medical Research Council (NHMRC)
Country [1] 256148 0
Australia
Primary sponsor type
Individual
Name
Dr Evangelia Daviskas
Address
Department of Respiratory and Sleep Medicine, 11 West, Building 75, Royal Prince Alfred Hospital Missenden Road, Camperdown, Sydney, NSW 2050
Country
Australia
Secondary sponsor category [1] 251491 0
None
Name [1] 251491 0
Address [1] 251491 0
Country [1] 251491 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258246 0
Ethics Review Committee of Sydney South West Area Health Service
Ethics committee address [1] 258246 0
Ethics committee country [1] 258246 0
Australia
Date submitted for ethics approval [1] 258246 0
10/08/2007
Approval date [1] 258246 0
16/10/2007
Ethics approval number [1] 258246 0
07/RPAH/32

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

Contacts
Principal investigator
Name 30594 0
Address 30594 0
Country 30594 0
Phone 30594 0
Fax 30594 0
Email 30594 0
Contact person for public queries
Name 13841 0
Dr Evangelia Daviskas
Address 13841 0
Department of Respiratory and Sleep Medicine, 11 West Building 75, Royal Prince Alfred Hospital, Missenden Road, Camperdown NSW 2050
Country 13841 0
Australia
Phone 13841 0
612 95157410
Fax 13841 0
61 2 95158196
Email 13841 0
[email protected]
Contact person for scientific queries
Name 4769 0
Dr Evangelia Daviskas
Address 4769 0
Department of Respiratory and Sleep Medicine, 11 West Building 75, Royal Prince Alfred Hospital, Missenden Road, Camperdown NSW 2050
Country 4769 0
Australia
Phone 4769 0
61 2 95157410
Fax 4769 0
61 2 95158196
Email 4769 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbaseBeneficial effect of inhaled mannitol and cough in asthmatics with mucociliary dysfunction.2010https://dx.doi.org/10.1016/j.rmed.2010.05.019
N.B. These documents automatically identified may not have been verified by the study sponsor.