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Trial registered on ANZCTR


Registration number
ACTRN12615000503527
Ethics application status
Approved
Date submitted
6/05/2015
Date registered
20/05/2015
Date last updated
12/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Periostin as a predictor of severe exacerbations in asthma
Scientific title
A study to determine periostin as a predictor of severe exacerbations in asthma in adult asthmatics
Secondary ID [1] 286565 0
Nil
Universal Trial Number (UTN)
U1111-1167-8494
Trial acronym
PER09
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 294817 0
Condition category
Condition code
Respiratory 295090 295090 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 in adult asthmatics will be measured at a single visit via a specific periostin assay. The periostin level will be compared to a sample taken at the baseline assessment, when the participant attended the Medical Research Insitute for the New Zealand Respiratory Health Survey (NZRHS) study and the Longitudinal study of periostin levels in asthma (PER02), occurring 1 to 5 years ago.
Intervention code [1] 291672 0
Not applicable
Comparator / control treatment
N/A - observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294851 0
The association between serum periostin and severe asthma exacerbations in adult asthmatics. The details of asthma exacerbations will be collected from participants directly via the Asthma Exacerbation Questionnaire, as well as consulting their General Practitioner (GP) and hospital medical records.
Timepoint [1] 294851 0
Both serum periostin and the Asthma Exacerbation Questionnaire will be performed on Day 1 at the enrollment visit. GP and hospital medical records will be assessed retrospectively starting from the date of their first visit at the Medical Research Institute to the date of their reassessment.
Secondary outcome [1] 314212 0
The association between serum periostin and the number of hospitalisations or Emergency Department (ED) attendances because of asthma, requiring systemic corticosteroids. This information will be gathered via the Asthma Exacerbation Questionnaire as well as consulting participant's GP and hospital medical records.

This exacerbation outcome is measured from the time of the baseline assessment in the New Zealand Respiratory Health Questionnaire (NZRHS) and periostin 2 (PER02) studies to the time of reassessment, between 1 and 5 years later.
Timepoint [1] 314212 0
Time of reassessment
Secondary outcome [2] 314213 0
The association between serum periostin and the number of courses of systemic corticosteroids taken. This information will be gathered via the Asthma Exacerbation Questionnaire as well as consulting participant's GP and hospital medical records.

This exacerbation outcome is measured from the time of the baseline assessment in the NZRHS and PER02 studies to the time of reassessment, between 1 and 5 years later.
Timepoint [2] 314213 0
Time of reassessment
Secondary outcome [3] 314214 0
The association between serum periostin and changes in asthma treatment (in accordance with stepwise approach to asthma treatment in Global Initiative for Asthma (GINA) guidelines). This information will be gathered via the Asthma Exacerbation Questionnaire as well as consulting participant's GP and hospital medical records.
Timepoint [3] 314214 0
Time of reassessment
Secondary outcome [4] 314215 0
The association between serum periostin and change in Forced Expired Volume in 1 second (FEV1) (ml/year) between the baseline measurement in the NZRHS and PER02 studies to the time of reassessment in PER09. FEV1 will be measured via spirometry.
Timepoint [4] 314215 0
Time of reassessment
Secondary outcome [5] 314216 0
The association between blood eosinophil count and the number of severe exacerbations of asthma per unit time. The blood eosinophil count will be measured from blood sample taken during the visit. This exacerbation outcome is measured from the time of the baseline assessment in the NZRHS and PER02 studies to the time of reassessment, between 1 and 5 years later.
Timepoint [5] 314216 0
Time of reassessment
Secondary outcome [6] 314217 0
The association between blood eosinophil count and the number of hospitalisations or ED attendances because of asthma, requiring systemic corticosteroids. This exacerbation outcome is measured from the time of the baseline assessment in the NZRHS and PER02 studies to the time of reassessment, between 1 and 5 years later.
Timepoint [6] 314217 0
Time of reassessment
Secondary outcome [7] 314342 0
The association between blood eosinophil count and the number of courses of systemic steroids taken (prescribed or self-administered). The number of courses of systemic steroids taken by a participant is obtained from their answers to the Asthma Exacerbation Questionnaire and through consulting their GP and hospital medical records. This exacerbation outcome is measured from the time of the baseline assessment in the NZRHS and PER02 studies to the time of reassessment, between 1 and 5 years later.
Timepoint [7] 314342 0
Time of reassessment
Secondary outcome [8] 314343 0
Exploratory outcomes analysing relationships between periostin levels and unspecified immune mediated biomarkers, as measured by laboratory assays
Timepoint [8] 314343 0
Time of reassessment
Secondary outcome [9] 314344 0
Exploratory outcomes analysing relationships between periostin levels and deoxyribonucleic acid (DNA) profiles, as measured by laboratory assays.
Timepoint [9] 314344 0
Time of reassessment
Secondary outcome [10] 314508 0
The association between blood eosinophil count and changes in asthma treatment (in accordance with stepwise approach to asthma treatment in GINA guidelines), measured from the time of the baseline assessment in the NZRHS and PER02 studies to the time of reassessment between 1 and 5 years later.

Changes in asthma treatment will be determined from the Asthma Exacerbation Questionnaire as well as consulting the participant's GP and hospital records.
Timepoint [10] 314508 0
Time of reassessment
Secondary outcome [11] 314509 0
The association between blood eosinophil count and the change in FEV1 (ml/yr), measured from the time of the baseline assessment in the NZRHS and PER02 studies to the time of reassessment between 1 and 5 years later.

Blood eosinophil count will be measured by laboratory assay. FEV1 will be measured via spirometry.
Timepoint [11] 314509 0
Time of reassessment
Secondary outcome [12] 314510 0
The association between serum IgE and the number of severe exacerbations of asthma, measured from the time of the baseline assessment in the NZRHS and PER02 studies to the time of reassessment between 1 and 5 years later.

Serum IgE will be analysed using standard laboratory assay and be collected via a blood sample.

The number of exacerbations of asthma will be obtained from the Asthma Exacerbation Questionnaire as well as consulting the participant's GP and hospital records.

Severe exacerbations of asthma are defined as the use of systemic corticosteroids for at least 3 consecutive days; or hospitalisation or ED attendances because of asthma, requiring systemic corticosteroids.
Timepoint [12] 314510 0
Time of reassessment
Secondary outcome [13] 314526 0
The association between serum IgE and the number of hospitalisations or ED attendances because of asthma, requiring systemic corticosteroids. This exacerbation outcome is measured from the time of the baseline assessment in the NZRHS and PER02 studies to the time of reassessment, between 1 and 5 years later.

The number of number of hospitalisations or ED attendances because of asthma will be obtained from the Asthma Exacerbation Questionnaire as well as consulting the participant's GP and hospital records.
Timepoint [13] 314526 0
Time of reassessment
Secondary outcome [14] 314527 0
The association between serum IgE levels and the number of courses of systemic steroids taken (prescribed or self-administered). This exacerbation outcome is measured from the time of the baseline assessment in the NZRHS and PER02 studies to the time of reassessment, between 1 and 5 years later.

The number of number of courses of systemic corticosteroids will be obtained from the Asthma Exacerbation Questionnaire as well as consulting the participant's GP and hospital records.
Timepoint [14] 314527 0
Time of reassessment
Secondary outcome [15] 314528 0
The association between serum IgE and changes in asthma treatment (in accordance with stepwise approach to asthma treatment in GINA guidelines), measured from the time of the baseline assessment in the NZRHS and PER02 studies to the time of reassessment between 1 and 5 years later.

Changes in asthma treatment will be determined from the Asthma Exacerbation Questionnaire as well as consulting the participant's GP and hospital records.
Timepoint [15] 314528 0
Time of reassessment
Secondary outcome [16] 314529 0
The association between serum IgE and the change in FEV1 (ml/yr), measured from the time of the baseline assessment in the NZRHS and PER02 studies to the time of reassessment between 1 and 5 years later.

Serum IgE will be measured by laboratory assay. FEV1 will be measured via spirometry.
Timepoint [16] 314529 0
Time of reassessment
Secondary outcome [17] 314530 0
The association between FeNO and the number of severe exacerbations of asthma, measured from the time of the baseline assessment in the NZRHS and PER02 studies to the time of reassessment between 1 and 5 years later.

The number of exacerbations of asthma will be obtained from the Asthma Exacerbation Questionnaire as well as consulting the participant's GP and hospital records.

Severe exacerbations of asthma are defined as the use of systemic corticosteroids for at least 3 consecutive days; or hospitalisation or ED attendances because of asthma, requiring systemic corticosteroids.

FeNO levels will be measured using a nitrous oxide monitor (NIOX) according to the American Thoracic Society (ATS) guidelines, published in 2005.
Timepoint [17] 314530 0
Time of reassessment
Secondary outcome [18] 314531 0
The association between FeNO and the number of hospitalisations or ED attendances because of asthma, requiring systemic corticosteroids. This exacerbation outcome is measured from the time of the baseline assessment in the NZRHS and PER02 studies to the time of reassessment, between 1 and 5 years later.

The number of number of hospitalisations or ED attendances because of asthma will be obtained from the Asthma Exacerbation Questionnaire as well as consulting the participant's GP and hospital records.
Timepoint [18] 314531 0
Time of reassessment
Secondary outcome [19] 314532 0
The association between FeNO and the number of courses of systemic steroids taken (prescribed or self-administered). This exacerbation outcome is measured from the time of the baseline assessment in the NZRHS and PER02 studies to the time of reassessment, between 1 and 5 years later.

The number courses of systemic corticosteroids taken will be obtained from the Asthma Exacerbation Questionnaire as well as consulting the participant's GP and hospital records.
Timepoint [19] 314532 0
Time of reassessment
Secondary outcome [20] 314533 0
The association between FENO and changes in asthma treatment (in accordance with stepwise approach to asthma treatment in GINA guidelines), measured from the time of the baseline assessment in the NZRHS and PER02 studies to the time of reassessment between 1 and 5 years later.

Changes in asthma treatment will be determined from the Asthma Exacerbation Questionnaire as well as consulting the participant's GP and hospital records.
Timepoint [20] 314533 0
Time of reassessment
Secondary outcome [21] 314534 0
The association between FENO and the change in FEV1 (ml/yr), measured from the time of the baseline assessment in the NZRHS and PER02 studies to the time of reassessment between 1 and 5 years later.

FeNO levels will be measured using a nitrous oxide monitor (NIOX) and FEV1 will be measured using spirometry, according to the American Thoracic Society (ATS) guidelines, published in 2005.
Timepoint [21] 314534 0
Time of reassessment
Secondary outcome [22] 314638 0
The associations between serum periostin and serum immunoglobulin type E (IgE) as markers of asthma severity. IgE will be measured by laboratory assay.
Timepoint [22] 314638 0
Time of reassessment
Secondary outcome [23] 314639 0
The associations between serum periostin and fractional exhaled nitrous oxide (FeNO) as markers of asthma severity. FeNO levels will be measured using a nitrous oxide monitor (NIOX) according the American Thoracic Society guidelines, published in 2005.
Timepoint [23] 314639 0
Time of reassessment.
Secondary outcome [24] 314662 0
The associations between serum periostin and blood eosinophil count as markers of asthma severity. Blood eosinophil count will be measured by laboratory assay.
Timepoint [24] 314662 0
Time of reassessment

Eligibility
Key inclusion criteria
Participants from:
-New Zealand Respiratory Health Survey (NZRHS) (ACTR number 12610000666022) phase two and
-Longitudinal study of serum periostin levels in asthma (PER02)(ACTR number 12614000235606)
Able to perform written informed consent
Minimum age
18 Years
Maximum age
95 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Known pregnancy
-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 last 3 months
-Active (current, or within the 3 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
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
356 participants will be approached to take part in the study, based on the number of participants previously recruited from the NZRHS and PER02 studies. Assuming a 35% attrition rate, it is envisaged that 230 participants will be enrolled into this study.

Statistical analyses:
Detailed data description using summary statistics, contingency tables, and plots will be used for both the explanatory and response variables including, where appropriate, descriptions of change with time. Our experience with analysis of Periostin, FeNO, and serum IgE, are they are typically highly skew and better analysed on the logarithm transformed scale.

For illustrative purposes data descriptions based on tertiles will also be calculated.

The statistical analysis will be appropriate to the response variable data type.
For the response variables treated as counts (exacerbations, hospital or ED admissions, and courses of steroids) this will be by Poisson regression with an offset for the time observation. It is possible that most of the participants will have no or only one count of a response variable and in this case it may be simpler to analyse the associations using logistic regression, using levels of none versus any.
For the response variable treated as continuous, FEV1, regression will be used, including the baseline FEV1 as a covariate.
For the response variable treated as ordinal, GINA asthma step, proportional odds (ordinal) regression will be used. If in the event there are mainly two asthma step levels achieved it may be simpler to analyse associations using logistic regression with GINA asthma step as a two level response variable.
Periostin will be used as an explanatory variable in both univariate and multivariate analyses.
In the univariate analyses, Periostin or logarithm Periostin, will be used as the sole explanatory variable
The other Th2-related variables: eosinophil count, IgE, and FeNO, will also be used in univariate analyses with each as a sole explanatory variable
Finally multivariate models will be estimated with all of eosinophil count, IgE, and FeNO, to explore if Periostin adds important explanatory power to prediction of poor asthma outcomes.

This is an exploratory analysis with a large number of statistical tests and although 95% confidence intervals, corresponding to a two-sided type I error rate of 5%, will be used, results will be interpreted cautiously because of multiple statistical testing and uncertainty as to what, for some variables, might constitute a clinically meaningful association.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2015
Actual
28/05/2015
Date of last participant enrolment
Anticipated
1/12/2016
Actual
15/06/2016
Date of last data collection
Anticipated
30/12/2016
Actual
31/01/2017
Sample size
Target
230
Accrual to date
Final
212
Recruitment outside Australia
Country [1] 6832 0
New Zealand
State/province [1] 6832 0
Wellington

Funding & Sponsors
Funding source category [1] 291126 0
Commercial sector/Industry
Name [1] 291126 0
Genentech, Inc.
Country [1] 291126 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
Country
New Zealand
Secondary sponsor category [1] 289802 0
None
Name [1] 289802 0
Address [1] 289802 0
Country [1] 289802 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292705 0
Central HDEC
Ethics committee address [1] 292705 0
Ethics committee country [1] 292705 0
New Zealand
Date submitted for ethics approval [1] 292705 0
12/03/2015
Approval date [1] 292705 0
31/03/2015
Ethics approval number [1] 292705 0
15/CEN/33

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 428 428 0 0
/AnzctrAttachments/368400-HDEC Letter 15CEN33 Approved FULL Application.pdf

Contacts
Principal investigator
Name 56658 0
Prof Richard Beasley
Address 56658 0
Medical Research Institute of New Zealand, Private Bag 7902, Wellington, 6242
Country 56658 0
New Zealand
Phone 56658 0
+64 4 805 0147
Fax 56658 0
Email 56658 0
richard.beasley@mrinz.ac.nz
Contact person for public queries
Name 56659 0
Ruth Semprini
Address 56659 0
Medical Research Institute of New Zealand, Private Bag 7902, Wellington, 6242
Country 56659 0
New Zealand
Phone 56659 0
+64 4 805 0232
Fax 56659 0
Email 56659 0
ruth.semprini@mrinz.ac.nz
Contact person for scientific queries
Name 56660 0
Ruth Semprini
Address 56660 0
Medical Research Institute of New Zealand, Private Bag 7902, Wellington, 6242
Country 56660 0
New Zealand
Phone 56660 0
+64 4 805 0232
Fax 56660 0
Email 56660 0
ruth.semprini@mrinz.ac.nz

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