Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000165987
Ethics application status
Approved
Date submitted
8/02/2011
Date registered
11/02/2011
Date last updated
7/01/2020
Date data sharing statement initially provided
7/01/2020
Date results information initially provided
7/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Microarray analysis following Anti-Inflammatory Interventions in Chronic Obstructive Pulmonary Disease (COPD)
Scientific title
The use of microarray analysis to examine the effects of an anti-inflammatory intervention containing statins, lycopene and fish oil in COPD.
Secondary ID [1] 253499 0
This trial does not have a secondary ID
Universal Trial Number (UTN)
Trial acronym
MAID Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 261044 0
Ex-smokers with obstructive airway disease 261046 0
Condition category
Condition code
Respiratory 259186 259186 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral Simvastatin 40mg (1 tablet daily for 12 weeks) with the addition of oral fish oil (DHA 200mg, EPA 300mg) 1g and oral lycomato (lycopene supplement) 500mg capsules (3 x capsules daily for 8 weeks) at week 4.
Intervention code [1] 257931 0
Treatment: Drugs
Intervention code [2] 258003 0
Treatment: Other
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262046 0
Using microarray analysis, sputum mRNA expression data
Timepoint [1] 262046 0
0, 4 and 12 weeks
Secondary outcome [1] 273026 0
Nil
Timepoint [1] 273026 0
Nil

Eligibility
Key inclusion criteria
Ex-smokers with a smoking history of a least 10 pack years, obstructive airway disease (FEV1/FVC ratio < 2SD below expected value for age, sex and height)
Minimum age
35 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Currently taking lipid lowering drugs or drugs that interact with statins, Subjects with active liver disease, renal impairment, cardiovascular disease, pregnant or breast feeding, subjects with known allergies or intolerance to statins or one of the dietary supplements

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)
Subjects who are eligible for the study will be invited to attend a screening visit. If eligible, they will be entered into the study. All subjects will receive the study intervention with no randomisation method to be employed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2011
Actual
1/06/2011
Date of last participant enrolment
Anticipated
Actual
8/10/2012
Date of last data collection
Anticipated
Actual
6/12/2012
Sample size
Target
15
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15573 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 28957 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 258400 0
Other
Name [1] 258400 0
Woolcock Institute of Medical Research - NHMRC CCRE Seed Project
Country [1] 258400 0
Australia
Primary sponsor type
Hospital
Name
Hunter New England Health Service
Address
John Hunter Hospital
Lookout Road
New Lambton Heights NSW 2305
Country
Australia
Secondary sponsor category [1] 257548 0
University
Name [1] 257548 0
University of Newcastle
Address [1] 257548 0
University Drive
Callaghan NSW 2308
Country [1] 257548 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260373 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 260373 0
Lookout Road
New Lambton Heights NSW 2305
Ethics committee country [1] 260373 0
Australia
Date submitted for ethics approval [1] 260373 0
28/01/2011
Approval date [1] 260373 0
01/03/2011
Ethics approval number [1] 260373 0

Summary
Brief summary
This study will use microarray analysis to investigate the effects of statins, antioxidant nutrients and omega-3 fatty acids (fish oil) in COPD. COPD is a condition that involves inflammation of the airways that can cause scarring and airflow limitation of the lung, with the primary cause being cigarette smoking. Statins are drugs which are usually used to lower cholesterol levels but are also known to have anti-inflammatory and possible antioxidant effects. Omega-3 fatty acids and antioxidants have also been found to be useful in reducing inflammation.
Hypothesis: Statins, antioxidants and fish oil supplements may have different and potentially complementary effects, on genes involved in inflammatory pathways. The combined use of these interventions may provide a superior approach to reducing inflammation and slowing deterioration of lung function in ex-smokers with obstructive airway disease.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 32142 0
Prof Lisa Wood
Address 32142 0
Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305
Country 32142 0
Australia
Phone 32142 0
+61 2 40420147
Fax 32142 0
Email 32142 0
[email protected]
Contact person for public queries
Name 15389 0
Prof Lisa Wood
Address 15389 0
Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305
Country 15389 0
Australia
Phone 15389 0
+61 2 40420147
Fax 15389 0
+61 2 40420046
Email 15389 0
[email protected]
Contact person for scientific queries
Name 6317 0
Prof Lisa Wood
Address 6317 0
Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305
Country 6317 0
Australia
Phone 6317 0
+61 2 40420147
Fax 6317 0
+61 2 40420046
Email 6317 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No - IPD will not be available


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Williams EJ, Baines KJ, Smart JM, Gibson PG, Wood ... [More Details]
Conference abstractNo Williams EJ, Baines KJ, Smart JM, Gibson PG, Wood ... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRosuvastatin, lycopene and omega-3 fatty acids: A potential treatment for systemic inflammation in COPD; a pilot study.2016https://dx.doi.org/10.1016/j.jnim.2016.04.006
N.B. These documents automatically identified may not have been verified by the study sponsor.