Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000122651
Ethics application status
Approved
Date submitted
23/01/2014
Date registered
31/01/2014
Date last updated
19/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A study comparing serum periostin levels in Caucasian and Chinese adult populations without asthma or any other significant respiratory co-morbidity, and comparing serum periostin levels in a Chinese adult population with mild asthma versus moderate/ severe asthma
Scientific title
A study comparing serum periostin levels in Caucasian and Chinese adult populations without asthma or any other significant respiratory co-morbidity, and comparing serum periostin levels in a Chinese adult population with mild asthma versus moderate/ severe asthma.
Secondary ID [1] 283969 0
Nil known
Universal Trial Number (UTN)
U1111-1150-5103
Trial acronym
PER07
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Serum Periostin levels 290997 0
Condition category
Condition code
Public Health 291341 291341 0 0
Epidemiology
Respiratory 295426 295426 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 levels
Serum Periostin levels will be measured at a single visit (at enrolment), via a specific periostin laboratory assay.
Intervention code [1] 288654 0
Not applicable
Comparator / control treatment
Previous study has provided the reference range for comparison of secondary outcomes to this study, i.e. there are no controls for this study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291335 0
Reference range (mean, median and 90% confidence intervals) of periostin levels in a non-asthmatic adult Chinese population. Serum periostin level results will be provided by a specific periostin laboratory assay.
Timepoint [1] 291335 0
Single visit - Serum Periostin level measured at enrolment visit, using a specific periostin laboratory assay.
Secondary outcome [1] 306541 0
Comparison of the periostin levels in non-asthmatic Caucasian and Chinese adults. Serum periostin level results will be provided by a specific periostin laboratory assay.
Timepoint [1] 306541 0
Single visit - assessed at enrolment visit
Secondary outcome [2] 306542 0
Comparison of the periostin levels in non-asthmatic and asthmatic Chinese adults. Serum periostin level results will be provided by a specific periostin laboratory assay.
Timepoint [2] 306542 0
Single visit - assessed at enrolment visit
Secondary outcome [3] 306543 0
Comparison of the Fractional Exhaled Nitric Oxide (FeNO) levels in non-asthmatic Caucasian and Chinese populations, as measured by a NIOX MINO device
Timepoint [3] 306543 0
Single visit - assessed at enrolment visit
Secondary outcome [4] 306544 0
Comparison of the blood eosinophil levels in non-asthmatic Caucasian and Chinese populations, as measured by a full blood count including white cell differential laboratory blood sample
Timepoint [4] 306544 0
Single visit - assessed at enrolment visit
Secondary outcome [5] 306545 0
Comparison of periostin levels between mild (taking a short acting beta agonist only) and moderate/severe (taking inhaled corticosteroids) asthmatics of Chinese descent. Serum periostin level results will be provided by a specific periostin laboratory assay.
Timepoint [5] 306545 0
Single visit - assessed at enrolment visit
Secondary outcome [6] 306546 0
Comparison of the serum IgE (immunoglobulin E) levels in non-asthmatic Caucasian and Chinese populations, as measured by laboratory blood sample
Timepoint [6] 306546 0
Single visit - assessed at enrolment visit
Secondary outcome [7] 306547 0
Exploratory outcomes analysing relationships between periostin level and immune mediated biomarkers, as measured by laboratory assays
Timepoint [7] 306547 0
Single visit - assessed at enrolment visit
Secondary outcome [8] 306548 0
Exploratory outcomes analysing relationships between periostin level and RNA- based biomarkers, as measured by laboratory assay
Timepoint [8] 306548 0
Single visit - assessed at enrolment visit
Secondary outcome [9] 306549 0
Exploratory outcomes analysing relationships between periostin level and DNA- based biomarkers, as measured by laboratory assay
Timepoint [9] 306549 0
Single visit - assessed at enrolment visit
Secondary outcome [10] 308075 0
Determine the effects of country of birth (New Zealand and Australia versus Asia) on periostin levels, as captured by a genogram recording ethnicity and country of birth
Timepoint [10] 308075 0
Single visit - assessed at enrolment visit

Eligibility
Key inclusion criteria
Between 18 to 75 years of age
Able to provide written informed consent
Born in New Zealand, Australia, China, Hong Kong, Taiwan, Singapore or other countries in Asia
Of Chinese descent, more specifically: Both parents that self-identify as ethnic Chinese
Residing in New Zealand for more than one year at Visit 1

For Group 1 (non-asthmatics), at least 10 male and 10 female participants will be recruited to each of the following four age bands; 18-30, 31-45, 46-60 and 61-75 years.
For Group 2 (asthmatics), participants will have a current diagnosis of asthma.
34 will have mild asthma (treated with a SABA) and 34 will have moderate/severe asthma (treated with an ICS).
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Group 1
Doctor’s diagnosis of Asthma, Chronic Bronchitis or COPD
Wheezing or use of respiratory inhalers in the past 12 months
Systemic Corticosteroids within the last three months

Group 1 and 2
Current smoker, or former smoker with a smoking history of greater than 10 pack-years.
Known pregnancy
First six weeks post-partum
Significant co morbidities (determined at investigator discretion)
Hospital admission within last three months
Surgery within last three 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 three months
Active (current, or within the three weeks prior to the visit) upper or lower respiratory tract infection
Any other safety concern at the investigator’s discretion

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
For the non-asthmatic cohort, estimates of the mean and median periostin levels and 90% confidence intervals for prediction will be determined for both Chinese and Caucasian ethnic groups by a general linear model. As periostin has a highly skewed distribution, we will perform the analysis on the logarithm transformed scale with a back-transformation to establish the 90% confidence interval for prediction. An estimate of the difference between the Chinese and Caucasian ethnic groups will also be calculated by the general linear model. An exploratory analysis will be done to examine the effects of country of birth (New Zealand and Australia vs Asia).
The sample size of 120 adults is based on the recommendations of the Clinical and Laboratory Standards Institute that 120 participants should be studied to allow 90% confidence intervals to be computed by non-parametric methods if normal distribution assumptions are not met. No stratification by age or sex will be undertaken, as there is no association between these variables and serum periostin levels. Based on the SD of the logarithm periostin of 0.22, a sample size of 120 in the Chinese group and 420 in the Caucasian group has 90% power with alpha 5% to detect a difference in mean logarithm periostin of 0.074 equivalent to a ratio of mean periostin of 1.08.
With regards to investigating if an association exists between asthma severity and serum periostin levels in a Chinese population, 68 participants are sufficient to detect a paired difference in periostin of 0.5 of a standard deviation with 80% power. The conventional interpretation of an effect size of 0.5 of a standard deviation is of a medium effect size. For a comparison between mild and moderate/severe asthma, a sample size of 68 has 90% power to detect a 0.8 standard deviation difference, a large effect size difference.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/05/2015
Actual
25/05/2015
Date of last participant enrolment
Anticipated
31/07/2015
Actual
9/11/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
188
Accrual to date
Final
188
Recruitment outside Australia
Country [1] 5771 0
New Zealand
State/province [1] 5771 0
Wellington, Auckland

Funding & Sponsors
Funding source category [1] 288601 0
Commercial sector/Industry
Name [1] 288601 0
Genentech Inc
Country [1] 288601 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] 287311 0
None
Name [1] 287311 0
Address [1] 287311 0
Country [1] 287311 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290463 0
Northern B HDEC
Ethics committee address [1] 290463 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] 290463 0
New Zealand
Date submitted for ethics approval [1] 290463 0
Approval date [1] 290463 0
15/01/2014
Ethics approval number [1] 290463 0
13/NTB/190

Summary
Brief summary
Levels of POSTN (a protein-coding gene, also known as osteoblast specific factor) expression and periostin have been measured in a number of tissues and disease states, and results from studies measuring serum periostin levels have indicated that there may be a difference in serum periostin levels in people of Chinese descent. This study endeavours to provide serum periostin levels in a healthy Chinese population which will then be compared to levels found in healthy Caucasians. Results from this study will be used to determine whether a serum periostin reference range is required for the Chinese population. The study will also look at the periostin levels in Chinese asthmatic patients, in order to determine if there is a difference in periostin levels between Chinese patients with and without asthma.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45822 0
Prof Richard Beasley
Address 45822 0
Medical Research Institute of New Zealand, Private Bag 7902, Wellington 6242
Country 45822 0
New Zealand
Phone 45822 0
+64 4 805 0147
Fax 45822 0
Email 45822 0
[email protected]
Contact person for public queries
Name 45823 0
Dr Rachel Caswell-Smith
Address 45823 0
Medical Research Institute of New Zealand Private Bag 7902, Wellington 6242
Country 45823 0
New Zealand
Phone 45823 0
+64 4 805 0247
Fax 45823 0
Email 45823 0
[email protected]
Contact person for scientific queries
Name 45824 0
Dr Rachel Caswell-Smith
Address 45824 0
Medical Research Institute of New Zealand Private Bag 7902, Wellington 6242
Country 45824 0
New Zealand
Phone 45824 0
+64 4 805 0247
Fax 45824 0
Email 45824 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
EmbaseSerum periostin levels in adults of Chinese descent: An observational study ACTRN12614000122651 ACTRN.2018https://dx.doi.org/10.1186/s13223-018-0312-3
N.B. These documents automatically identified may not have been verified by the study sponsor.