Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001055291
Ethics application status
Approved
Date submitted
5/06/2018
Date registered
25/06/2018
Date last updated
3/11/2020
Date data sharing statement initially provided
3/11/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The New Zealand Bronchiectasis Registry: an Observational Study of Patients with Bronchiectasis in New Zealand
Scientific title
The New Zealand Bronchiectasis Registry: an Observational Study of Patients with Bronchiectasis in New Zealand. Factors affecting quality of life, and markers of severity.
Secondary ID [1] 294939 0
Nil known
Universal Trial Number (UTN)
U1111-1214-3849
Trial acronym
NZBR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiectasis 307912 0
Condition category
Condition code
Respiratory 306956 306956 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
20
Target follow-up type
Years
Description of intervention(s) / exposure
- This is an observational study concerning patients of all ages (no lower or upper age limit) with non-cystic fibrosis bronchiectasis, modelled on the Europe-wide EMBARC registry and affiliated with the Australian Bronchiectasis Registry. Ethics and localities approval has already been obtained.

- Data will be collected in two distinct fields
a) Baseline study entry:as a basic dataset
b) Annual review: follow-up data completed for each year of the study,
indicating yearly exacerbation frequency, hospitalisations and survival status

- Patients will need to provide written consent to be included (or have parental consent if too young to do so)
- Participation will involve face-to-face visits, either as part of routine clinical care or through additional visits to clinic. Contact may also be made via telephone.

- Additional observations will include investigations performed in determining aetiology of patients' bronchiectasis, spirometry/lung function, history of exacerbations, sputum microbiology and quality of life assessments
(NOTE - all of these observations are performed as part of routine clinical care; no additional investigations are proposed purely for research purposes)

- This is planned to be an ongoing registry with no definite end-point
Intervention code [1] 301257 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305943 0
- Quality of life assessment using "Quality of Life in Bronchiectasis" (QOL-B) questionnaire
Timepoint [1] 305943 0
Assessed at baseline, and annually (no definite end-point as this is an ongoing registry).
Primary outcome [2] 306235 0
- Exacerbation frequency in last 12 months
Self-reported by patient and checked against antibiotic prescription data
Timepoint [2] 306235 0
Assessed at baseline, and annually (no definite end-point as this is an ongoing registry).
Primary outcome [3] 306236 0
- Sputum sample microbiology results (by species, as per laboratory reports of routine and mycobacterial culture of sputum samples provided in the last 12 months)
Timepoint [3] 306236 0
Assessed at baseline, and annually (no definite end-point as this is an ongoing registry).
Secondary outcome [1] 347086 0
Co-morbidities (for baseline characteristics purposes):
Patient-reported and from access to local medical records
- e.g. documented history of COPD, asthma, cardiovascular diseases (myocardial infarction, angina, stroke, atrial fibrillation, pulmonary hypertension), liver cirrhosis, osteoporosis, depression, anxiety, chronic kidney disease, neoplastic disease, diabetes
Timepoint [1] 347086 0
Assessed at baseline, and annually (no definite end-point as this is an ongoing registry).
Secondary outcome [2] 347934 0
- Sputum purulence in stable state
Patient reported (mucoid vs. mucopurulent vs. purulent)
Timepoint [2] 347934 0
Assessed at baseline, and annually (no definite end-point as this is an ongoing registry).
Secondary outcome [3] 347935 0
- Spirometry (FEV, FVC, FEV1:FVC ratio)
Timepoint [3] 347935 0
Assessed at baseline, and annually (no definite end-point as this is an ongoing registry).
Secondary outcome [4] 347936 0
- MRC breathlessness score
Timepoint [4] 347936 0
Assessed at baseline, and annually (no definite end-point as this is an ongoing registry).
Secondary outcome [5] 347937 0
- Aetiology of bronchiectasis
Based on patient history, radiological features and pre-existing investigations as per European Respiratory Society guidelines for investigation of bronchiectasis and as per the EMBARC collaboration
e.g. history of pneumonia, childhood illness, tuberculosis or other mycobacterial infection, rheumatoid arthritis or other connective tissue disease, inflammatory bowel disease, HIV, immunodeficiency, primary ciliary dyskinesia, aspiration, gastro-oesophageal reflux, congenital airway abnormality or post-obstructive
Timepoint [5] 347937 0
Assessed at baseline, and reviewed annually (no definite end-point as this is an ongoing registry).
Secondary outcome [6] 347938 0
- Radiological extent of the bronchiectasis (which lobes affected)
Timepoint [6] 347938 0
Assessed at baseline from CT scan of thorax prior to inclusion in the registry
Secondary outcome [7] 347939 0
- Treatments for bronchiectasis (for example oral, inhaled/nebulised treatments, physiotherapy, pulmonary rehabilitation)
Data to be collected from patients at consultation and correlated with clinical records
Timepoint [7] 347939 0
Assessed at baseline, and annually (no definite end-point as this is an ongoing registry).
Secondary outcome [8] 348235 0
"Bronchiectasis Health Questionnaire" as additional measure of quality of life
Timepoint [8] 348235 0
Assessed at baseline, and annually (no definite end-point as this is an ongoing registry).
Secondary outcome [9] 348494 0
- Number of exacerbations requiring hospital admission in last 12 months
Patient reported and hospital discharge summary data
Timepoint [9] 348494 0
Assessed at baseline, and annually (no definite end-point as this is an ongoing registry).
Secondary outcome [10] 348495 0
Sputum volume (ml/day) as estimated by patient
Timepoint [10] 348495 0
Assessed at baseline, and annually (no definite end-point as this is an ongoing registry).

Eligibility
Key inclusion criteria
Patient of any age with clinical history consistent with bronchiectasis
Has a CT chest scan consistent with bronchiectasis
Does not have known cystic fibrosis
Has not had a previous lung or heart transplant
Has provided signed written consent to inclusion in the study, or written consent provided by parent or legal representative if aged <16
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No diagnosis of bronchiectasis (or no CT confirming this diagnosis)
Is known to have cystic fibrosis
Has had a previous lung or heart transplant
Is unable to consent to inclusion in the study

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Study size: no upper limit of recruitment. New Zealand-wide involvement is encouraged to enable accurate representation of the country.

An agreed minimum dataset with up-to-date results will ensure high quality data during the keeping of the registry. Minimum annual dataset will include:
- Microbiology
- Spirometry
- Exacerbation history
- Annual quality of life questionnaires

Comparison analyses may be made once sufficient data has been collected, to other published data from EMBARC and Australian Bronchiectasis Registry.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
198
Final
Recruitment outside Australia
Country [1] 10413 0
New Zealand
State/province [1] 10413 0
Counties Manukau, Hutt Valley, Waikato and Canterbury District Health Boards

Funding & Sponsors
Funding source category [1] 299524 0
Self funded/Unfunded
Name [1] 299524 0
N/a
Country [1] 299524 0
Primary sponsor type
Hospital
Name
Counties Manukau Health
Address
Department of Respiratory Medicine
Counties Manukau DHB
100 Hospital Road
Papatoetoe
2025
Country
New Zealand
Secondary sponsor category [1] 299012 0
None
Name [1] 299012 0
Address [1] 299012 0
Country [1] 299012 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300421 0
Health and Disability Ethics Committees, New Zealand
Ethics committee address [1] 300421 0
Ethics committee country [1] 300421 0
New Zealand
Date submitted for ethics approval [1] 300421 0
05/09/2017
Approval date [1] 300421 0
11/10/2017
Ethics approval number [1] 300421 0

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

Contacts
Principal investigator
Name 83610 0
Dr Conroy Wong
Address 83610 0
Department of Respiratory Medicine
Counties Manukau DHB
Middlemore Hospital
Hospital Road
Auckland
2025
Country 83610 0
New Zealand
Phone 83610 0
+64 9276 0000
Fax 83610 0
Email 83610 0
[email protected]
Contact person for public queries
Name 83611 0
Paul Dawkins
Address 83611 0
Department of Respiratory Medicine
Counties Manukau DHB
Middlemore Hospital
Hospital Road
Auckland
2025
Country 83611 0
New Zealand
Phone 83611 0
+64 9276 0000
Fax 83611 0
Email 83611 0
[email protected]
Contact person for scientific queries
Name 83612 0
Paul Dawkins
Address 83612 0
Department of Respiratory Medicine
Counties Manukau DHB
Middlemore Hospital
Hospital Road
Auckland
2025
Country 83612 0
New Zealand
Phone 83612 0
+64 9276 0000
Fax 83612 0
Email 83612 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


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.