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Trial registered on ANZCTR


Registration number
ACTRN12609000977279
Ethics application status
Approved
Date submitted
9/11/2009
Date registered
12/11/2009
Date last updated
22/04/2020
Date data sharing statement initially provided
22/01/2020
Date results information initially provided
22/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Statins as an anti-inflammatory in asthma
Scientific title
Statins as an effective anti-inflammatory therapy against diet-induced neutrophilic asthma
Secondary ID [1] 286686 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SAIL Study (Statins Asthma Inflammation and Lipids)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 237177 0
Condition category
Condition code
Respiratory 237501 237501 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
High fat challenge before and after Oral Simvastatin 40mg (1 tablet daily for 1 month)
Intervention code [1] 236885 0
Treatment: Drugs
Comparator / control treatment
High fat challenge before and after Oral Simvastatin Placebo equivalent 40mg (inactive) containing lactose, 1 tablet daily for 1 month
Control group
Placebo

Outcomes
Primary outcome [1] 238312 0
Postprandial change in sputum neutrophils
Timepoint [1] 238312 0
4 weeks following randomisation
Secondary outcome [1] 244703 0
Postprandial change in Interleukin 6 (IL-6) from blood analysis
Timepoint [1] 244703 0
4 weeks following randomisation

Eligibility
Key inclusion criteria
Stable asthma (with or without neutrophilic asthma)
Body Mass Index (BMI) < 30
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current smokers,
Currently taking lipid lowering drugs or drugs that interact with statins.
Subjects with active liver disease, renal impairment, cardiovascular disease, pregnant or breastfeeding

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)
Following Informed Consent and screening for eligibilty for the study, subjects will be allocated a randomisation number. The allocation of the randomisation number will be done by the study co-ordinator sequencially, who will be unaware which group the subject will be allocated (active or placebo). The subject will then be given a container with the randomisation number attached. The generation of the randomisation schedule and the labelling of the study container will be carried out be independent persons not directly involved with the study subjects and concealed from the study staff.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed by using a randomisation table created by a computer software program. Therefore computerised sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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 in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 237280 0
University
Name [1] 237280 0
University of Newcastle
Address [1] 237280 0
University Drive, Callaghan, NSW, 2308
Country [1] 237280 0
Australia
Primary sponsor type
Individual
Name
Prof Lisa Wood
Address
Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 236766 0
University
Name [1] 236766 0
University of Newcastle
Address [1] 236766 0
University Drive
Callaghan NSW 2308
Country [1] 236766 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239378 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 239378 0
Lookout Road
New Lambton Heights NSW 2305
Ethics committee country [1] 239378 0
Australia
Date submitted for ethics approval [1] 239378 0
30/06/2009
Approval date [1] 239378 0
10/08/2009
Ethics approval number [1] 239378 0
HNEHREC Reference No.: 09/07/15/3.05

Summary
Brief summary
This study will investigate a possible therapeutic strategy to modify diet-induced airway inflammation by the use of statins. The regular intake of high fat food directly causes systemic inflammation. This systemic inflammation may lead to asthma or contribute to increased airway inflammation seen in asthma. Statins are a widely prescribed class of cholesterol lowering drugs indicated for the prevention of cardiovascular disease. They have also be shown to reduce or inhibit inflammatory markers (C-Reactive Protein CRP, IL-6) and cytokines associated with innate immunity (Tumor Necrosis Factor-alpha TNF-alpha, Interleukin-8 IL-8). We propose that statins, which suppress the innate immune response, will suppress the neutrophilic inflammation that we expect as a consequence of a high fat diet.
Hypothesis: A high fat diet causes an increase in neutrophilic airway inflammation. Statins will protect against fat-induced inflammation in asthma.
Trial website
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 29859 0
Prof Lisa Wood
Address 29859 0
Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305
AUSTRALIA
Country 29859 0
Australia
Phone 29859 0
+61240420147
Fax 29859 0
+61 2 4042 0046
Email 29859 0
lisa.wood@newcastle.edu.au
Contact person for public queries
Name 13106 0
Prof Lisa Wood
Address 13106 0
Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305
AUSTRALIA
Country 13106 0
Australia
Phone 13106 0
+61240420147
Fax 13106 0
+61 2 40420046
Email 13106 0
lisa.wood@newcastle.edu.au
Contact person for scientific queries
Name 4034 0
Prof Lisa Wood
Address 4034 0
Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305
AUSTRALIA
Country 4034 0
Australia
Phone 4034 0
+61 2 4042 0147
Fax 4034 0
+61 2 4042 0046
Email 4034 0
lisa.wood@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary