Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000443695
Ethics application status
Approved
Date submitted
23/04/2014
Date registered
30/04/2014
Date last updated
24/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to determine the change in serum periostin level over 12 weeks in adult patients following a severe exacerbation of asthma
Scientific title
A study to determine the change in serum periostin level over 12 weeks in adult patients following a severe exacerbation of asthma
Secondary ID [1] 284473 0
Nil known
Universal Trial Number (UTN)
U1111-1150-0474
Trial acronym
PER03
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Periostin levels, in asthmatics following an exacerbation of their asthma 291712 0
Condition category
Condition code
Respiratory 292090 292090 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 6 visits over 12 weeks (Day 1 [enrolment visit-within 24 hours of admission to hospital], week 1, week 2, week 4, week 8 and week 12) via a specific periostin laboratory assay
Intervention code [1] 289236 0
Not applicable
Comparator / control treatment
N/A - observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291963 0
Changes in periostin level over the 12 weeks following a severe exacerbation of asthma
Timepoint [1] 291963 0
Serum Periostin levels will be measured at Day 1 (enrolment visit-within 24 hours of admission to hospital), week 1, week 2, week 4, week 8 and week 12
Secondary outcome [1] 307932 0
Associations between periostin and respiratory health, as measured by the Asthma Quality of Life Questionnaire (AQLQ) score
Timepoint [1] 307932 0
Day 1, week 12
Secondary outcome [2] 307933 0
Associations between periostin and non-asthmatic health conditions, as captured by a study specific general health questionnaire (e.g. diabetes)
Timepoint [2] 307933 0
Day 1
Secondary outcome [3] 307934 0
Associations between periostin and Spirometry (Forced Expiratory Volume in 1 second [FEV1] and Forced Vital Capacity [FVC]) parameters, as measured by a spirometer
Timepoint [3] 307934 0
Day 1 , week 1, week 2, week 4, week 8 and week 12
Secondary outcome [4] 307935 0
Associations between periostin and Fractional Exhaled Nitric Oxide (FeNO) level, as measured by a NIOX MINO device
Timepoint [4] 307935 0
Day 1 , week 1, week 2, week 4, week 8 and week 12
Secondary outcome [5] 307936 0
Associations between periostin and full blood count including white cell differential, as measured by laboratory blood samples
Timepoint [5] 307936 0
Day 1 , week 1, week 2, week 4, week 8 and week 12
Secondary outcome [6] 307937 0
Associations between periostin and serum IgE (Immunglobulin E), as measured by laboratory blood samples
Timepoint [6] 307937 0
Day 1 , week 1, week 2, week 4, week 8 and week 12
Secondary outcome [7] 307938 0
Exploratory outcomes analysing relationships between periostin level and immune mediated biomarkers, as measured by laboratory assays
Timepoint [7] 307938 0
Day 1 , week 1, week 2, week 4, week 8 and week 12
Secondary outcome [8] 307939 0
Exploratory outcomes analysing relationships between periostin level and RNA- based biomarkers, as measured by laboratory assay
Timepoint [8] 307939 0
Day 1 , week 1, week 2, week 4, week 8 and week 12

Eligibility
Key inclusion criteria
Aged between 18 to 75 years
Able to provide written informed consent
Doctor diagnosis of asthma
Exacerbation of asthma, defined as one or both of the following criteria:
Use of systemic corticosteroids (tablets, suspension, or injection), or an increase from a stable maintenance dose, for at least 3 days. For consistency, courses of corticosteroids separated by 1 week or more should be treated as separate severe exacerbations.
A hospitalization or Emergency Department visit because of asthma, requiring systemic corticosteroids. requiring admission to hospital
Participants prescribed a dose of systemic corticosteroids for at least 3 days will be eligible for the study, though it is recognised they will not have taken systemic corticosteroids for 3 days at the point of enrolment. Participants will not be eligible if they have commenced systemic corticosteroids greater than 24 hours prior to enrolment.
Participants who have increased from their stable maintenance dose of systemic corticosteroids will only be eligible if this dose increase is confirmed to be less than 24 hours prior to enrolment.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known Pregnancy
Significant co morbidities (determined at investigator discretion)
Hospital admission within last 3 months for condition other than asthma
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 month
Any other safety concern at the investigator’s discretion

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
34 Participants are sufficient to detect a paired difference in periostin of 0.5 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.
The periostin levels will be plotted against time and a non-parametric scatter plot smoother will be used to determine if there is pattern of variation with time that might be usefully explored with parametric regression (eg linear, quadratic, cubic time terms). Paired t-test and mixed linear models will be used to compare the 12 week periostin level with measurements at the other times to formally compare the change with time.
This analysis may need to be performed on the log-transformed scale

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2014
Actual
27/06/2014
Date of last participant enrolment
Anticipated
31/12/2015
Actual
27/11/2015
Date of last data collection
Anticipated
Actual
20/02/2016
Sample size
Target
34
Accrual to date
Final
34
Recruitment outside Australia
Country [1] 6019 0
New Zealand
State/province [1] 6019 0
Wellington

Funding & Sponsors
Funding source category [1] 289124 0
Commercial sector/Industry
Name [1] 289124 0
Genentech, Inc.
Country [1] 289124 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] 287785 0
None
Name [1] 287785 0
Address [1] 287785 0
Country [1] 287785 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290905 0
Northern B HDEC
Ethics committee address [1] 290905 0
Ethics committee country [1] 290905 0
New Zealand
Date submitted for ethics approval [1] 290905 0
Approval date [1] 290905 0
15/01/2014
Ethics approval number [1] 290905 0
13/NTB/191

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47890 0
Prof Richard Beasley
Address 47890 0
Medical Research Institute of New Zealand Private Bag 7902, Wellington 6242, New Zealand
Country 47890 0
New Zealand
Phone 47890 0
+64 4 805 0147
Fax 47890 0
Email 47890 0
[email protected]
Contact person for public queries
Name 47891 0
Rachel Caswell-Smith
Address 47891 0
Medical Research Institute of New Zealand Private Bag 7902, Wellington 6242, New Zealand
Country 47891 0
New Zealand
Phone 47891 0
+64 4 805 0247
Fax 47891 0
Email 47891 0
[email protected]
Contact person for scientific queries
Name 47892 0
Rachel Caswell-Smith
Address 47892 0
Medical Research Institute of New Zealand Private Bag 7902, Wellington 6242, New Zealand
Country 47892 0
New Zealand
Phone 47892 0
+64 4 805 0247
Fax 47892 0
Email 47892 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
EmbaseChange in biomarkers of type-2 inflammation following severe exacerbations of asthma.2019https://dx.doi.org/10.1136/thoraxjnl-2018-211657
N.B. These documents automatically identified may not have been verified by the study sponsor.