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Trial registered on ANZCTR


Registration number
ACTRN12614000072617
Ethics application status
Approved
Date submitted
24/12/2013
Date registered
21/01/2014
Date last updated
1/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to determine the effect of sampling time on serum periostin levels in adult participants with and without asthma
Scientific title
A study to determine the effect of sampling time on serum periostin levels in adult participants with and without asthma
Secondary ID [1] 283816 0
Nil known
Universal Trial Number (UTN)
U1111-1150-3967
Trial acronym
PER06
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Serum Periostin levels
Serum Periostin levels will be measured at 6 time points (baseline and 2 hourly up to 10 hours post baseline) at a single visit, via a specific periostin laboratory assay.
290792 0
Condition category
Condition code
Respiratory 291160 291160 0 0
Asthma

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Serum Periostin level.
Serum Periostin levels will be measured 6 times at a single visit, results will be obtained via a specific periostin laboratory assay.
Baseline measurement will take place between 7-9am and 5 further measurements will be taken at 2 hourly intervals, on the day of the clinic visit
Intervention code [1] 288504 0
Not applicable
Comparator / control treatment
N/A - observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291148 0
Effect of sampling time on serum periostin levels.
Serum periostin level results taken from each timepoint at visit 2 will be provided by the specific periostin laboratory assay and statistically assessed.
Timepoint [1] 291148 0
Single visit, with sampling timepoints 2 hourly (Baseline, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours) over a 10 hour period. Baseline measurements will take place from 7-9am, at Visit 2. Visit 2 will take place up to 2 weeks post Visit 1. Visit 1 will consist of consent and enrolment.
Secondary outcome [1] 306139 0
Associations between periostin and non-asthmatic health conditions (as captured by general health questionnaire, e.g. diabetes)
Timepoint [1] 306139 0
Visit 2: Baseline
(Visit 2 may take place up to 2 weeks post Visit 1).
Secondary outcome [2] 306140 0
Associations between periostin and respiratory health, as captured by Asthma Quality of Life Questionnaire (AQLQ)
Timepoint [2] 306140 0
Visit 2: Baseline
(Visit 2 may take place up to 2 weeks post Visit 1).
Secondary outcome [3] 306141 0
Associations between periostin and respiratory health, as captured by the Asthma Control Questionnaire (ACQ)
Timepoint [3] 306141 0
Visit 2: Baseline
(Visit 2 may take place up to 2 weeks post Visit 1).
Secondary outcome [4] 306142 0
Associations between periostin and spirometry (Forced expiratory volume in 1 second [FEV1] and Forced Vital Capacity [FVC]) as measured by a spirometer
Timepoint [4] 306142 0
Visit 2 - Baseline, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours
(Visit 2 may take place up to 2 weeks post Visit 1).
Secondary outcome [5] 306143 0
Associations between periostin and Fractional exhaled Nitric Oxide (FeNO) level, as measured by a NIOX MINO device
Timepoint [5] 306143 0
Visit 2 - Baseline, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours
(Visit 2 may take place up to 2 weeks post Visit 1).
Secondary outcome [6] 306144 0
Associations between periostin and eosinophil levels, as measured by laboratory blood samples
Timepoint [6] 306144 0
Visit 2 - Baseline, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours
(Visit 2 may take place up to 2 weeks post Visit 1).
Secondary outcome [7] 306145 0
Exploratory outcomes analysing relationships between periostin level and immune mediated biomarkers, as measured by laboratory assays
Timepoint [7] 306145 0
Visit 2 - Baseline, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours
(Visit 2 may take place up to 2 weeks post Visit 1).
Secondary outcome [8] 306146 0
Exploratory outcomes analysing relationships between periostin level and RNA- based biomarkers, as measured by laboratory assay
Timepoint [8] 306146 0
Visit 2 - Baseline, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours
(Visit 2 may take place up to 2 weeks post Visit 1).

Eligibility
Key inclusion criteria
Aged between 18 to 75 years
Able to provide written informed consent
Doctor diagnosis of asthma and on stable dose of Inhaled Corticosteroids (ICS) and/or Long Acting Beta Agonist (LABA) for past 3 months,
OR no doctor diagnosis of asthma and no wheeze for past 12 months.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Documented lung condition other than Asthma (prior diagnosis or discovered as part of screening assessments)
Known pregnancy
Significant co morbidities (determined at investigator discretion)
Hospital admission within last 3 months
Surgery within last 3 months, determined at investigator discretion (this includes all major surgery requiring general anaesthetic, dental extractions and root canal procedures. This does not include minor procedures, including but not limited to mole or wart removal, dental fillings etc).
Bone fracture within the last 3 months
Oral or Systemic Corticosteroids within the last 3 months
Any other safety concern at the investigator’s discretion

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
A sample size of 16 has 80% power, alpha 5%, to detect a difference of 0.75 standard deviations, and a sample size of 32 of about 0.5 standard deviations, for continuous variables. A sample size of 16 (in each group) gives good precision for estimation of variance.
Our experience is that periostin and Fractional exhaled Nitric Oxide (FeNO) have highly skew distributions and are likely to need analysis on the logarithm transformed scale. The main analysis will be by paired t-tests. For variables needing a logarithm transformation this is interpreted as the ratio of means when back –transformed. A linear mixed model will be used to compare the difference between the paired measurements by normal and asthma groups.

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 outside Australia
Country [1] 5697 0
New Zealand
State/province [1] 5697 0
Wellington

Funding & Sponsors
Funding source category [1] 288476 0
Commercial sector/Industry
Name [1] 288476 0
Genentech, Inc.
Address [1] 288476 0
Genentech, Inc.
1 DNA Way, South San Francisco,
CA 94080-4990
USA
Country [1] 288476 0
United States of America
Primary sponsor type
Charities/Societies/Foundations
Name
Medical Research Institute of New Zealand
Address
Medical Research Institute of New Zealand
Level 7 CSB, Wellington Hospital
Riddiford Street
Newtown
Wellington 6021
New Zealand
Country
New Zealand
Secondary sponsor category [1] 287177 0
None
Name [1] 287177 0
Address [1] 287177 0
Country [1] 287177 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290340 0
Northern B HDEC
Ethics committee address [1] 290340 0
Health and Disability Ethics Committees
Ministry of Health
C/- MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 290340 0
New Zealand
Date submitted for ethics approval [1] 290340 0
18/11/2013
Approval date [1] 290340 0
15/01/2014
Ethics approval number [1] 290340 0
13/NTB/184

Summary
Brief summary
Levels of POSTN (a protein-coding gene, also known as osteoblast specific factor) gene expression and periostin have been measured in a number of tissues and disease states, including asthma. As yet an incomplete picture is currently available on the role and effects of periostin level in the blood, however it has shown promise as a biomarker for asthma severity and a marker of inflammation levels, being easy to measure through a simple blood test. This study of the sample time variation of periostin in patients with stable asthma compared with patients without asthma would provide further information on the production of periostin and whether sampling time affects the level of periostin measured in the blood, and if there is a difference between the general population and asthmatics in this regard.
This study is part of a programme of research being undertaken by the Medical Research Institute of New Zealand, aimed at furthering knowledge of periostin, in order to discover its clinical usefulness.
Trial website
Trial related presentations / publications
Caswell-Smith R, Cripps T, Charles T, Hosking A, Handigol M, Holweg C, Matthews J, Holliday M, Maillot C, Fingleton J, Weatherall M. Day-time variation of serum periostin in asthmatic adults treated with ICS/LABA and adults without asthma. Allergy, Asthma & Clinical Immunology. 2017 Feb 8;13(1):8.

DOI: 10.1186/s13223-017-0182-0
Public notes

Contacts
Principal investigator
Name 45182 0
Prof Richard Beasley
Address 45182 0
Medical Research Institute of New Zealand Private Bag 7902, Wellington 6242, New Zealand
Country 45182 0
New Zealand
Phone 45182 0
+64 4 805 0147
Fax 45182 0
Email 45182 0
richard.beasley@mrinz.ac.nz
Contact person for public queries
Name 45183 0
Dr Rachel Caswell-Smith
Address 45183 0
Medical Research Institute of New Zealand Private Bag 7902, Wellington 6242, New Zealand
Country 45183 0
New Zealand
Phone 45183 0
+64 4 805 0247
Fax 45183 0
Email 45183 0
rachel.caswell-smith@mrinz.ac.nz
Contact person for scientific queries
Name 45184 0
Dr Rachel Caswell-Smith
Address 45184 0
Medical Research Institute of New Zealand Private Bag 7902, Wellington 6242, New Zealand
Country 45184 0
New Zealand
Phone 45184 0
+64 4 805 0247
Fax 45184 0
Email 45184 0
rachel.caswell-smith@mrinz.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary