ANZCTR - Registration

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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

ACTRN12619001572156

Ethics application status

Approved

Date submitted

30/10/2019

Date registered

14/11/2019

Date last updated

10/09/2020

Date data sharing statement initially provided

14/11/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

National Breathlessness Survey (Australia)

Scientific title

National Breathlessness Survey (Australia); an observational study of breathlessness in Australian adults

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1242-0956

Trial acronym

NBS (National Breathlessness Survey)

Linked study record

Not applicable

Health condition

Health condition(s) or problem(s) studied:

breathlessness

asthma

chronic obstructive pulmonary disease (COPD)

Condition category

Condition code

Respiratory

Asthma

Respiratory

Chronic obstructive pulmonary disease

Respiratory

Other respiratory disorders / diseases

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

This is a cross-sectional study of prevalence of breathlessness (as measured by mMRC scale of dyspnoea score) in a population sample of Australian adults. Thus far, the median length time taken to complete the survey is approximately 14 minutes.

Intervention code [1]

Not applicable

Comparator / control treatment

Not applicable

Control group

Uncontrolled

Outcomes

Primary outcome [1]

The percentage of the Australian population with mMRC breathlessness/dyspnoea score greater than or equal to 1.

Timepoint [1]

At the time of the survey

Secondary outcome [1]

prevalence of breathlessness (mMRC breathlessness/dyspnoea score 1+) in adults with and without a diagnosis of lung disease (determined by study-specific survey)

Timepoint [1]

At the time of the survey

Secondary outcome [2]

Frequency of breathlessness - continuous or intermittent (determined by study-specific survey)

Timepoint [2]

at the time of the survey

Secondary outcome [3]

impact of breathlessness - Dyspnoea-12

Timepoint [3]

at the time of the survey

Secondary outcome [4]

prevalence of smoking - study-specific survey

Timepoint [4]

lifetime, assessed at time of survey

Secondary outcome [5]

health care utilisation among people with breathlessness (assessed using study-specific survey)

Timepoint [5]

over the last 12 months, assessed at the time of the survey

Secondary outcome [6]

Medication use among people with breathlessness (assessed using study-specific survey)

Timepoint [6]

in last 12 months, assessed at the time of the survey

Secondary outcome [7]

prevalence of respiratory disease (other than asthma and COPD) that may be associated with breathlessness (determined by study-specific survey)

Timepoint [7]

assessed at the time of the survey

Secondary outcome [8]

prevalence of breathlessness (mMRC breathlessness/dyspnoea score 1+) in adults with and without a diagnosis of cardiovascular disease (determined by study-specific survey

Timepoint [8]

assessed at the time of the survey

Secondary outcome [9]

impact of breathlessness - SF-1

Timepoint [9]

assessed at the time of the survey

Secondary outcome [10]

impact of breathlessness - EuroQol-5L-5D

Timepoint [10]

assessed at the time of the survey

Secondary outcome [11]

impact of breathlessness - patient health questionnaire-4

Timepoint [11]

assessed at the time of the survey

Secondary outcome [12]

prevalence of exposure to tobacco smoke

Timepoint [12]

lifetime, assessed at time of survey

Secondary outcome [13]

prevalence of exposure to dust or fumes (study-specific survey)

Timepoint [13]

lifetime, assessed at the time of the survey

Secondary outcome [14]

prevalence of living near a main road (study-specific survey)

Timepoint [14]

lifetime, assessed at the time of the survey

Secondary outcome [15]

prevalence of cardiovascular disease (assessed using study-specific survey)

Timepoint [15]

assessed at the time of the survey

Secondary outcome [16]

prevalence of obesity/overweight (assessed by BMI calculated from self-reported height and weight)

Timepoint [16]

assessed at the time of the survey

Secondary outcome [17]

prevalence of anxiety/depression (assessed using study-specific survey)

Timepoint [17]

assessed at the time of the survey

Eligibility

Key inclusion criteria

Age 18 years or over
Resident of Australia
Member of an existing, large web-based Australian survey panel.

*please note that this study is a random population survey, so volunteers cannot be accepted*

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

There are no exclusion criteria.

Study design

Purpose

Duration

Cross-sectional

Selection

Random sample

Timing

Both

Statistical methods / analysis

Descriptive statistics

Recruitment

Recruitment status

Suspended

Date of first participant enrolment

Anticipated

Actual

14/10/2019

Date of last participant enrolment

Anticipated

31/12/2021

Actual

30/10/2019

Date of last data collection

Anticipated

31/12/2021

Actual

Sample size

Target

30000

Accrual to date

10072

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

GlaxoSmithKline

Address [1]

1061 Mountain Highway Boronia, Victoria, 3155 AUSTRALIA

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

AstraZeneca

Address [2]

66 Talavera Road Macquarie Park NSW 2113 AUSTRALIA

Country [2]

Australia

Funding source category [3]

Commercial sector/Industry

Name [3]

Novartis

Address [3]

Novartis Pharmaceuticals Australia 54 Waterloo Rd Macquarie Park NSW 2113 AUSTRALIA

Country [3]

Australia

Primary sponsor type

Other

Name

Woolcock Institute of Medical Research

Address

431 Glebe Point Rd
Glebe NSW 2037

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Sydney Human Research Ethics Committee

Ethics committee address [1]

Research Integrity & Ethics Administration
Research Portfolio
Level 3, F23 Administration Building
The University of Sydney
NSW 2006 Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/06/2019

Approval date [1]

05/08/2019

Ethics approval number [1]

2019/621

Summary

Brief summary

The aim of the National Breathlessness Survey is to evaluate respiratory symptom burden (breathlessness, cough, wheeze and/or chest tightness), treatment, healthcare utilisation and patient attitudes and beliefs in a randomly selected adult population, irrespective of any current diagnostic assignment. 
Specifically, the National Breathlessness Survey aims to:
• Describe the prevalence (and severity) of breathlessness in adults with or without a self-reported, doctor-diagnosed illness of asthma, COPD, bronchiectasis, or cardiac disease.
• Describe the frequency of breathlessness and the impact of breathlessness on quality of life in adults with or without a self-reported, doctor-diagnosed illness of asthma, COPD, bronchiectasis or cardiac disease.
• Quantify how many people have exposure to known risk factors for developing breathlessness or experiencing adverse health outcomes of contributory conditions, including the presence of comorbidities (e.g. exposure to tobacco products, occupational exposure to fumes, dust and asthmagens, inactivity/obesity).
• Assess healthcare utilisation among people with breathlessness.

Trial website

N/A

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Helen Reddel

Address

Australian Centre for Airways disease Monitoring (ACAM) Woolcock Institute of Medical Research 431 Glebe Point Road Glebe NSW 2037 Australia

Country

Australia

Phone

+61 2 9114 0437

Fax

+61 2 9114 0011

[email protected]

Contact person for public queries

Name

Helen Reddel

Address

Australian Centre for Airways disease Monitoring (ACAM) Woolcock Institute of Medical Research 431 Glebe Point Road Glebe NSW 2037 Australia

Country

Australia

Phone

+61 2 9114 0437

Fax

+61 2 9114 0011

[email protected]

Contact person for scientific queries

Name

Helen Reddel

Address

Australian Centre for Airways disease Monitoring (ACAM) Woolcock Institute of Medical Research 431 Glebe Point Road Glebe NSW 2037 Australia

Country

Australia

Phone

+61 2 9114 0437

Fax

+61 2 9114 0011

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• These data will be available to researchers who provide a methodologically sound proposal

Conditions for requesting access:
• -

What individual participant data might be shared?

• de-dentified individual participant data underlying published results

What types of analyses could be done with individual participant data?

• These data will be available only to achieve the aims outlined in the approved proposal.

When can requests for individual participant data be made (start and end dates)?

From:
2 years after article publication with no end date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Data access will be subject to approval by Principal Investigator - Prof Helen Reddel - via email ([email protected]).
Proposals will be reviewed by the National Breathlessness Survey research team. To gain access, data requesters will need to sign a data access agreement and to confirm that data will only be used for the agreed purpose for which access was granted.

Are there extra considerations when requesting access to individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically