Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000818235
Ethics application status
Approved
Date submitted
24/07/2009
Date registered
18/09/2009
Date last updated
26/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of N-acetylcysteine supplementation on oxidation status and alveolar inflammation in people exposed to asbestos: a double-blind randomised clinical trial
Scientific title
A randomised, double blind, placebo-controlled trial to evaluate the safety and efficacy of N-acetylcysteine for reducing lung inflammation and oxidation in subjects exposed to asbestos
Secondary ID [1] 283839 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asbestos related lung disease 237359 0
Condition category
Condition code
Respiratory 239680 239680 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
N-acetylcysteine
a) 1800mg/day (2 x 900mg capsules)
b) 16 weeks
c) oral - effervescent capsule
Intervention code [1] 237014 0
Prevention
Comparator / control treatment
Placebo
a) ingredients: Main -sodium (200mg). Others - citric acid, sodium bicarbonate, sodium carbonate, mannitol, wildberry flavor, acesulfame potassium, trisodium dicitrate
b) 1800mg/day (2 x 900mg capsules)
c) 16 weeks
d) oral - effervescent capsule
Control group
Placebo

Outcomes
Primary outcome [1] 240450 0
Difference in F2-isoprostane between intervention and placebo groups. F2-isoprostane to be measured in exhaled breath condensate using high performance liquid chromatography (HPLC)
Timepoint [1] 240450 0
Baseline and at 1, 2, 3 and 4 months after intervention commencement
Primary outcome [2] 240451 0
Blood markers of oxidative stress. these include; F2-isoprostane, total anti-oxidant capacity, total plasma thiols, protein carbonyl content. These will be assessed by normal laboratory processes for these compounds.
Timepoint [2] 240451 0
Baseline and at 1, 2, 3 and 4 months after intervention commencement
Primary outcome [3] 240452 0
Indicators of alveolar inflammation measured in broncho-alveolar lavage fluid (tumour necrosis factor-alpha and interleukin 8 in alveolar macrophages). This will be collected in a subset (n = 5) of subjects from both groups
Timepoint [3] 240452 0
at baseline and 4 months after intervention commences
Secondary outcome [1] 244971 0
Potential side-effects. To be assessed by self-reported questionnaire. These include nausea, headache, dyspepsia, heartburn, allergic response, fever and any respiratory symptoms.
Timepoint [1] 244971 0
at baseline and 1, 2, 3 and 4 months after intervention and at any time during intervention period if any potential side-effect is experienced by participant

Eligibility
Key inclusion criteria
Males attending the WA Asbestos Review Program, including former workers of a crocidolite mine and ex-residents from the former crocidolite mining town of Wittenoom
Minimum age
40 Years
Maximum age
70 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Current diagnosis of any asbestos related disease
Current diagnosis of chronic repspiratory disease, such as asthma or chronic obstructive pulmonary disease
Current smokers
People taking any of the following drugs; angiotensin-converting enzyme (ACE) inhibitors, cisplatin or doxorubican, nitroglycerin and isosorbide

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration
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?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Two-group comparisons, comparing changes from baseline between groups.
Mixed regression model

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/01/2010
Actual
26/05/2010
Date of last participant enrolment
Anticipated
Actual
24/10/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
54
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 237398 0
Government body
Name [1] 237398 0
Workers' Compensation Dust Diseases Board of NSW
Country [1] 237398 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
35 Stirling Highway
CRAWLEY WA 6009
Country
Australia
Secondary sponsor category [1] 236895 0
None
Name [1] 236895 0
Address [1] 236895 0
Country [1] 236895 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239529 0
Sir Charles Gairdner Hospital Human Research Ethics Committee (HREC)
Ethics committee address [1] 239529 0
Ethics committee country [1] 239529 0
Australia
Date submitted for ethics approval [1] 239529 0
29/09/2009
Approval date [1] 239529 0
14/01/2010
Ethics approval number [1] 239529 0
2009-149

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

Contacts
Principal investigator
Name 29965 0
Prof Bill Musk
Address 29965 0
Department of Respiratory Medicine, Sir Charles Gairdner Hospital, Hospital Avenue NEDLANDS, Western Australia, 6009
Country 29965 0
Australia
Phone 29965 0
+61 8 9346 4528
Fax 29965 0
Email 29965 0
[email protected]
Contact person for public queries
Name 13212 0
Peter Franklin
Address 13212 0
School of Population Health
University of Western Australia
35 Stirling Highway
CRAWLEY WA 6009
Country 13212 0
Australia
Phone 13212 0
+61 8 64887091
Fax 13212 0
+61 8 64881611
Email 13212 0
[email protected]
Contact person for scientific queries
Name 4140 0
Bill Musk
Address 4140 0
Department of Respiratory Medicine,
Sir Charles Gairdner Hospital,
Hospital Avenue
NEDLANDS, Western Australia, 6009
Country 4140 0
Australia
Phone 4140 0
+61 8 9346 4528
Fax 4140 0
Email 4140 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
SourceTitleYear of PublicationDOI
EmbaseEffect of N-acetylcysteine supplementation on oxidative stress status and alveolar inflammation in people exposed to asbestos: A double-blind, randomized clinical trial.2015https://dx.doi.org/10.1111/resp.12592
N.B. These documents automatically identified may not have been verified by the study sponsor.