Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619000468123
Ethics application status
Approved
Date submitted
13/03/2019
Date registered
21/03/2019
Date last updated
6/03/2020
Date data sharing statement initially provided
21/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Respiratory Health of Pacific Youth: Risk and Resilience Throughout Childhood
Scientific title
Respiratory Health of Pacific Youth: Risk and Resilience Throughout Childhood
Secondary ID [1] 297700 0
Health Research Council Grant: 17/155
Universal Trial Number (UTN)
Trial acronym
PIF Study
Linked study record
Covariate information for this study including risk and protective factors, confounders and early-life respiratory conditions, will be collected from the below studies' databases:

- Pacific Islands Families Study: The First Two Years of Life (PIF: FTY)
Grant reference number: AIT801
Auckland Regional Ethics Committee X (Reference 99/055 )

- Pacific Islands Families Study: Transition to School (PIF:TTS)
Grant reference number: AITX0202
Northern X Ethics

Health condition
Health condition(s) or problem(s) studied:
Respiratory health 312000 0
Condition category
Condition code
Respiratory 310565 310565 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The respiratory assessment is taking place in one 3-hour visit undertaken by a research nurse.
It includes the below study procedures:
• A clinical assessment including respiratory and general medical histories, current respiratory symptoms and severity, recent respiratory events, and a clinical examination (height, weight, heart rate, breathing rate, blood pressure, listening to particpant's chest breathing and heart sounds, ear nose and throat examination)
• Assessment of lung function with spirometry
• Completing Quality of Life (St. George’s Respiratory Questionnaire and EuroQol five dimensions questionnaire) and sleep questionnaires (Epworth Sleepiness Scale Questionnaire)
• Having blood tests and chest x-ray
Intervention code [1] 313931 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319419 0
Forced Expiratory Volume in 1 second (FEV1) z-score standardised for height, gender and age (ATS/ERS criteria using Global Lung Initiative reference values) as a continuous variable. The FEV1 z-score will be dichotomised to an indicator of z-score < -1.64 for the purpose of estimating population attributable risk.
Timepoint [1] 319419 0
At the time of assessing the 18-19 year participants (2018-2019)
Secondary outcome [1] 368088 0
(1) Other lung function parameters: Forced Vital Capacity (FVC) measured by spirometry
Timepoint [1] 368088 0
At the time of assessing the 18-19 year participants (2018-2019)
Secondary outcome [2] 368401 0
(2) Other lung function parameters: FEV1/ FVC ratio measured by spirometry
Timepoint [2] 368401 0
At the time of assessing the 18-19 year participants (2018-2019)
Secondary outcome [3] 368402 0
(3) Other lung function parameters: Forced Expiratory Flow (FEF) measured by spirometry
Timepoint [3] 368402 0
At the time of assessing the 18-19 year participants (2018-2019)
Secondary outcome [4] 368403 0
(4) Presence or absence of respiratory disease at the current assessment; doctor-diagnosed disease, presence of symptoms, signs of respiratory disease (wheeze, crackles, chest deformity, clubbing, abnormal lung function) by clinical assessment.
Timepoint [4] 368403 0
At the time of assessing the 18-19 year participants (2018-2019)
Secondary outcome [5] 368404 0
(5) History of a pulmonary exacerbation in the previous 12 months by clinical assessment.
Timepoint [5] 368404 0
At the time of assessing the 18-19 year participants (2018-2019)
Secondary outcome [6] 368405 0
(6) Health-related quality of life by St. George’s Respiratory Questionnaire
Timepoint [6] 368405 0
At the time of assessing the 18-19 year participants (2018-2019)
Secondary outcome [7] 368406 0
(7) Health-related quality of life by EuroQol five dimensions questionnaire
Timepoint [7] 368406 0
At the time of assessing the 18-19 year participants (2018-2019)
Secondary outcome [8] 368493 0
(8) Health-related quality of life by sleep questionnaire (Epworth Sleepiness Scale Questionnaire)
Timepoint [8] 368493 0
At the time of assessing the 18-19 year participants (2018-2019)
Secondary outcome [9] 368494 0
(9) Chest x-ray score measured by Brasfield score
Timepoint [9] 368494 0
At the time of assessing the 18-19 year participants (2018-2019)
Secondary outcome [10] 368495 0
(10) Markers of atopy and asthma- total IgE by blood tests
Timepoint [10] 368495 0
At the time of assessing the 18-19 year participants (2018-2019)
Secondary outcome [11] 368496 0
(11) Markers of disease -immunoglobulin levels IgG, IgA, IgM by blood tests (composite outcome)
Timepoint [11] 368496 0
At the time of assessing the 18-19 year participants (2018-2019)

Eligibility
Key inclusion criteria
This study draws its participants from an existing cohort; Pacific Islands Families Study.
Minimum age
18 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1-Those who have permanently dropped out of the study.
2-Those who are living out of Auckland, New Zealand.
3-Those who are unwell on the day of their respiratory assessment.

Study design
Purpose
Duration
Cross-sectional
Selection
Defined population
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/06/2018
Date of last participant enrolment
Anticipated
Actual
14/11/2019
Date of last data collection
Anticipated
Actual
14/11/2019
Sample size
Target
500
Accrual to date
Final
466
Recruitment outside Australia
Country [1] 21343 0
New Zealand
State/province [1] 21343 0
Auckland

Funding & Sponsors
Funding source category [1] 302223 0
Government body
Name [1] 302223 0
Health Research Council of New Zealand
Country [1] 302223 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
Auckland University of Technology - South Campus
MB Building, Level 2, Rm MB203
640 Great South Road
Manukau, Auckland 2104
Country
New Zealand
Secondary sponsor category [1] 302141 0
None
Name [1] 302141 0
Address [1] 302141 0
Country [1] 302141 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302903 0
Central Health and Disability Ethics Committees
Ethics committee address [1] 302903 0
Ethics committee country [1] 302903 0
New Zealand
Date submitted for ethics approval [1] 302903 0
Approval date [1] 302903 0
24/05/2018
Ethics approval number [1] 302903 0
18/CEN/24

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

Contacts
Principal investigator
Name 91790 0
Dr El-Shadan (Dan) Tautolo
Address 91790 0
AUT UNIVERSITY - South Campus
MB Building, Level 2, Rm MB203
640 Great South Road
Manukau, Auckland 2104
Country 91790 0
New Zealand
Phone 91790 0
+64 9 921 9999 ext 7527
Fax 91790 0
Email 91790 0
[email protected]
Contact person for public queries
Name 91791 0
El-Shadan (Dan) Tautolo
Address 91791 0
AUT UNIVERSITY - South Campus
MB Building, Level 2, Rm MB203
640 Great South Road
Manukau, Auckland 2104
Country 91791 0
New Zealand
Phone 91791 0
+64 9 921 9999 ext 7527
Fax 91791 0
Email 91791 0
[email protected]
Contact person for scientific queries
Name 91792 0
El-Shadan (Dan) Tautolo
Address 91792 0
AUT UNIVERSITY - South Campus
MB Building, Level 2, Rm MB203
640 Great South Road
Manukau, Auckland 2104
Country 91792 0
New Zealand
Phone 91792 0
+64 9 921 9999 ext 7527
Fax 91792 0
Email 91792 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Consent to participate in the study includes consent for access to data by immediate study staff, unless required by legislative or regulatory agencies.


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
No additional documents have been identified.