Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000235606
Ethics application status
Approved
Date submitted
26/02/2014
Date registered
5/03/2014
Date last updated
1/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to determine the eight-week longitudinal variation in serum periostin levels in a population with stable asthma.
Scientific title
A study to determine the eight-week longitudinal variation in serum periostin levels in a population with stable asthma.
Secondary ID [1] 283972 0
Nil known
Universal Trial Number (UTN)
U1111-1150-0071
Trial acronym
PER02
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Periostin levels, in stable asthmatics 291000 0
Condition category
Condition code
Respiratory 291604 291604 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 11 visits (Days 1 [enrolment visit], 2, 3, 4, 5, 10, 17, 24, 31, 38 and 59) via a specific periostin laboratory assay.
Intervention code [1] 288657 0
Not applicable
Comparator / control treatment
N/A - observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291339 0
Longitudinal variation in serum periostin level over an eight-week period.
Timepoint [1] 291339 0
Serum perisotin will be measured at Days: 1 [enrolment visit], 2, 3, 4, 5, 10, 17, 24, 31, 38, 59
Secondary outcome [1] 306551 0
Associations between periostin, eosinophils and respiratory health, as measured by the Asthma Quality of Life Questionnaire (AQLQ) score. Periostin and eosinophil count will be measured by serum assay.
Timepoint [1] 306551 0
Day 1
Secondary outcome [2] 306552 0
Associations between periostin, eosinophils and non-asthmatic health conditions, as captured by a study specific general health questionnaire (e.g. diabetes). Periostin and eosinophil count will be measured by serum assay.
Timepoint [2] 306552 0
Day 1
Secondary outcome [3] 307041 0
Associations between periostin, eosinophils and Spirometry (Forced Expiratory Volume in 1 second [FEV1] and Forced Vital Capacity [FVC]) parameters, as measured by a spirometer. Periostin and eosinophil count will be measured by serum assay.
Timepoint [3] 307041 0
Day 1
Secondary outcome [4] 307042 0
Associations between periostin, eosinophils and Fractional Exhaled Nitric Oxide (FeNO) level, as measured by a NIOX MINO device. Periostin and eosinophil count will be measured by serum assay.
Timepoint [4] 307042 0
Day 1
Secondary outcome [5] 307043 0
Associations between periostin and full blood count including white cell differential, as measured by laboratory blood samples
Timepoint [5] 307043 0
Day 1
Secondary outcome [6] 307044 0
Associations between periostin, eosinophils and serum IgE (Immunglobulin E), as measured by laboratory blood samples (serum assay)
Timepoint [6] 307044 0
Day 1
Secondary outcome [7] 307045 0
Associations between periostin, eosinophils and asthma control, as captured by the Asthma Control Questionnaire (ACQ). Periostin and eosinophil count will be measured by serum assay.
Timepoint [7] 307045 0
Days 1, 10, 17, 24, 31, 38 and 59
Secondary outcome [8] 307046 0
Exploratory outcomes analysing relationships between periostin level and immune mediated biomarkers, as measured by laboratory assays
Timepoint [8] 307046 0
Days: 1, 2, 3, 4, 5, 10, 17, 24, 31, 38, 59
Secondary outcome [9] 307047 0
Exploratory outcomes analysing relationships between periostin level and RNA- based biomarkers, as measured by laboratory assay
Timepoint [9] 307047 0
Days: 1, 2, 3, 4, 5, 10, 17, 24, 31, 38, 59
Secondary outcome [10] 311421 0
Investigation of potential associations between serum periostin and eosinophils. Periostin and eosinophil count will be measured by serum assay.
Timepoint [10] 311421 0
Days 1, 2, 3, 4, 5, 10, 17
Secondary outcome [11] 311422 0
Exploratory outcome investigating the variation of eosinophils. Eosinophil count will be measured by serum assay
Timepoint [11] 311422 0
Days 1, 2, 3, 4, 5, 10, 17

Eligibility
Key inclusion criteria
Aged between 18 to 75 years
Able to provide written informed consent
Doctor diagnosis of asthma
On a stable asthma treatment regime for greater than or equal to 3 months prior to visit 1, taking regular inhaled medication for asthma (including maintenance inhaled corticosteroid and long acting beta agonists)
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unstable asthma (as determined by the investigator and/or a change in asthma medication in last 3 months)
Oral or Systemic Corticosteroids within the last 3 months
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
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
Prospective
Statistical methods / analysis
60 Participants will be recruited to the study. Assuming at most 20% withdrawal/exclusion rates during the study this will ensure complete data on at least 50 participants. An achieved sample size of 50 has reasonable precision for estimates of variance.

Statistical analysis: The baseline characteristics of the population will be described and the variance and mean values for serum periostin will be calculated for participants who complete the study without developing a severe exacerbation. Confidence intervals for the variance of periostin will be calculated using a Chi-square statistic. This analysis may need to be performed on the log transformed scale.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/03/2014
Actual
10/03/2014
Date of last participant enrolment
Anticipated
31/03/2015
Actual
16/02/2015
Date of last data collection
Anticipated
Actual
15/04/2015
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 5853 0
New Zealand
State/province [1] 5853 0
Wellington

Funding & Sponsors
Funding source category [1] 288793 0
Commercial sector/Industry
Name [1] 288793 0
Genentech, Inc.
Country [1] 288793 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] 287489 0
None
Name [1] 287489 0
Address [1] 287489 0
Country [1] 287489 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290636 0
Northern B HDEC
Ethics committee address [1] 290636 0
Ethics committee country [1] 290636 0
New Zealand
Date submitted for ethics approval [1] 290636 0
Approval date [1] 290636 0
15/01/2014
Ethics approval number [1] 290636 0
13/NTB/185

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

Contacts
Principal investigator
Name 45830 0
Prof Richard Beasley
Address 45830 0
Medical Research Institute of New Zealand Private Bag 7902, Wellington 6242, New Zealand
Country 45830 0
New Zealand
Phone 45830 0
+64 4 805 0147
Fax 45830 0
Email 45830 0
[email protected]
Contact person for public queries
Name 45831 0
Rachel Caswell-Smith
Address 45831 0
Medical Research Institute of New Zealand Private Bag 7902, Wellington 6242, New Zealand
Country 45831 0
New Zealand
Phone 45831 0
+64 4 805 0247
Fax 45831 0
Email 45831 0
[email protected]
Contact person for scientific queries
Name 45832 0
Rachel Caswell-Smith
Address 45832 0
Medical Research Institute of New Zealand Private Bag 7902, Wellington 6242, New Zealand
Country 45832 0
New Zealand
Phone 45832 0
+64 4 805 0247
Fax 45832 0
Email 45832 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
Dimensions AIMorpholino-based correction of hypomorphic ZAP70 mutation in an adult with combined immunodeficiency2017https://doi.org/10.1016/j.jaci.2017.02.002
N.B. These documents automatically identified may not have been verified by the study sponsor.