ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619000287134

Ethics application status

Approved

Date submitted

22/02/2019

Date registered

26/02/2019

Date last updated

4/02/2020

Date data sharing statement initially provided

26/02/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Using impulse oscillometry, multiple-breath nitrogen washout and exhaled nitric oxide together to assess asthma inflammation

Scientific title

Using impulse oscillometry, multiple-breath nitrogen washout and exhaled nitric oxide before and after salbutamol inhalation to determine the site and degree of airways inflammation in patients with asthma

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1223-1286

Trial acronym

Linked study record

Health condition

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

Asthma

Condition category

Condition code

Respiratory

Asthma

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

One dose of inhaled salbutamol (600mcg) given by research staff via metered-dose inhaler (with spacer) over 10 minutes at one study visit.

Intervention code [1]

Treatment: Drugs

Intervention code [2]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Change in exhaled nitric oxide measured by exhaled nitric oxide analyser

Timepoint [1]

Change from baseline to 30 min post dosing.

Secondary outcome [1]

Change in area of reactance measured by impulse oscillometry.

Timepoint [1]

Change from baseline to 30 min post dosing.

Secondary outcome [2]

Change in lung clearance index measured by multiple breath nitrogen washout.

Timepoint [2]

Change from baseline to 30 min post dosing.

Secondary outcome [3]

Change in Scond (index of ventilation heterogeneity in the conducting airways) measured by multiple breath nitrogen washout.

Timepoint [3]

Change from baseline to 30 min post dosing.

Secondary outcome [4]

Change in Sacin (index of ventilation heterogeneity in the acinar airways) measured by multiple breath nitrogen washout.

Timepoint [4]

Change from baseline to 30 min post dosing.

Secondary outcome [5]

Change in forced vital capacity measured by spirometry.

Timepoint [5]

Change from baseline to 30 min post dosing.

Secondary outcome [6]

Change in R5-R20 measured by impulse oscillometry.

Timepoint [6]

Change from baseline to 30 min post dosing.

Eligibility

Key inclusion criteria

Physician-diagnosed asthma requiring a minimum of treatment with regular inhaled corticosteroid.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

Diagnosis of COPD, bronchiectasis, lung cancer.
Other co-morbidity likely to affect study participation.
Current smoker (any cigarette smoking within past two months).
Previous ICU admission for acute asthma.

Study design

Purpose of the study

Diagnosis

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Not applicable

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Not applicable

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Phase 4

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

11/03/2019

Actual

18/03/2019

Date of last participant enrolment

Anticipated

Actual

15/11/2019

Date of last data collection

Anticipated

Actual

15/11/2019

Sample size

Target

40

Accrual to date

Final

40

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Otago

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Otago

Address [1]

University of Otago 362 Leith Street Dunedin New Zealand 9054

Country [1]

New Zealand

Primary sponsor type

University

Name

University of Otago

Address

University of Otago
362 Leith Street
Dunedin
New Zealand
9054

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Health and Disability Ethics Committee

Ethics committee address [1]

Health and Disability Ethics Committees
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

22/11/2018

Approval date [1]

20/12/2018

Ethics approval number [1]

18/STH/248

Summary

Brief summary

It has been argued that, because of the complex relationship between FENO and airway calibre, FENO should not be measured alone but should instead be integrated into an ‘inflammometer’ that comprises FENO measurement and physiological measurement of airways obstruction.  Unfortunately, measures of small airways obstruction are not routinely used in clinical practice and this region of the lung has been described as the ‘silent zone’ as a consequence.

Impulse oscillometry and multiple breath nitrogen washout are physiological tests that can measure variables related to small airways obstruction in a research setting and they have become more reliable and user-friendly in recent years.  We intend to explore the relationship between FENO and measures of small airways obstruction in patients with asthma.  In particular, the relationship between FENO and measures related to small airways obstruction using impulse oscillometry has not previously been examined.  This is important because, like FENO, impulse oscillometry is a simple, easy test for patients.  If we could determine a relationship between FENO and measures obtained from impulse oscillometry, it might ultimately be possible to integrate the two into an ‘inflammometer’ that could be used clinically.

In this study, we will test the hypothesis that, in the presence of a stable airway inflammatory state, there is a relationship between baseline physiological measures of small airways obstruction and the change in FENO on subsequent bronchodilation with inhaled ß2-agonist.

We will recruit 40 participants with physician-diagnosed asthma.  They will be asked to withhold short-acting inhaled asthma treatment for 6 hours and long-acting inhaled asthma treatment for 12-24 hours prior to a single visit to the Otago Respiratory Research Unit.  At that visit, we will obtain informed consent, collect demographic data from participants and they will complete an asthma control questionnaire. Then impulse oscillometry, FENO measurement, multiple breath nitrogen washout and spirometry will be undertaken (1) at baseline and (2) after inhaled ß2-agonist therapy (bronchodilation).

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Jack Dummer

Address

Department of Medicine Dunedin School of Medicine University of Otago PO Box 56 Dunedin 9054

Country

New Zealand

Phone

+64 34709362

Fax

Email

[email protected]

Contact person for public queries

Name

Jack Dummer

Address

Department of Medicine Dunedin School of Medicine University of Otago PO Box 56 Dunedin 9054

Country

New Zealand

Phone

+64 34709362

Fax

Email

[email protected]

Contact person for scientific queries

Name

Jack Dummer

Address

Department of Medicine Dunedin School of Medicine University of Otago PO Box 56 Dunedin 9054

Country

New Zealand

Phone

+64 34709362

Fax

Email

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

No
No IPD sharing reason/comment: If de-identified participant data is requested for publication we will make this available. If it is requested by a 3rd party we will give this consideration.

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.