ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622001084774

Ethics application status

Approved

Date submitted

21/07/2022

Date registered

4/08/2022

Date last updated

1/09/2024

Date data sharing statement initially provided

4/08/2022

Type of registration

Retrospectively registered

Titles & IDs

Public title

Measuring airway smooth muscle using optical coherence tomography in patients undergoing bronchoscopy – an observation study.

Scientific title

Heterogeneity of increased thickness of the airway smooth muscle layer in asthma.

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

HASMA

Linked study record

Health condition

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

Asthma

Condition category

Condition code

Respiratory

Asthma

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

We aim to measure the area of airway smooth muscle in large and small airways of patients undergoing bronchoscopy. The bronchoscopies will be performed by clinicians experienced in interventional bronchoscopy and are all employed by the WA Department of Health. They will also undertake the PS-OCT probe procedure. They will introduce the catheter containing the optic fibre through the bronchoscope into the airway and maintain the bronchoscope and catheter in place while measurements are made and data collected by the engineer / biophysicist. This procedure will add an extra 10-15 minutes to the duration of the procedure, which normally takes around 25 minutes.

Apart from adding time to the procedure, there are no significant risks associated with the planned PS-OCT measurements. The optical fibre is enclosed in a soft plastic catheter (sheath) and the laser is non-heating and will not damage the airway wall. The catheter will be passed out into the small (2 mm diameter) airways. Adverse events or serious adverse events will be assessed by the non-medical and medical investigators and, if necessary, immediate counselling or first aid will be administered. Serious adverse events will be immediately referred to the emergency on-call team with specialist intervention (e.g. emergency department or intensive care teams) as appropriate.

All adverse events or serious adverse events (those requiring medical assessment or admission to hospital) will be recorded on the Adverse Events form. This form will be submitted to the Human Research Ethics Committee as part of quarterly reporting (non-serious adverse events) or within 24 hours (serious adverse events).

Follow-up of adverse events will be by the investigators in the first instance and by the usual medical team or appropriate medical team (e.g. emergency medical staff) in the case of a serious adverse event. All adverse events will be recorded in the participant study file and followed until resolution.

Participants will be studied in the hospital setting, currently approved at Sir Charles Gairdner Hospital and in the future, will be at Fiona Stanley Hospital as well. Participants will be initially informed of the study by the doctor who will perform the bronchoscopy. These doctors are participating as investigators in this study. Patients who agree to learn more about the study will then be contacted by a post-doctoral researcher to discuss the study in detail. Prior to the bronchoscopy, the researcher will provide patient information sheets, answer questions pertaining to the study and obtain informed consent. Participants will also fill in a Respiratory Health questionnaire. After informed consent is obtained, the researcher will collect participant medical history as well as lung function measurements. Additional time taken for the above-mentioned recruitment procedure will take about 30 minutes.

Intervention code [1]

Not applicable

Comparator / control treatment

Patients without asthma undergoing interventional bronchoscopy. We aim to measure the amount of airway smooth muscle in large and small airways in this cohort. An experienced bronchoscopist will be taking the measurements guided by the engineer / biophysicist.

Control group

Active

Outcomes

Primary outcome [1]

We aim to measure the area of airway smooth muscle in large airways of the lung using endoscopic polarisation-sensitive optical coherence tomography.

Timepoint [1]

Measurements of airway smooth muscle area / thickness will be assessed during the bronchoscopy.

Primary outcome [2]

We also aim to measure the area of airway smooth muscle in the smaller airways using endoscopic polarisation-sensitive optical coherence tomography

Timepoint [2]

Measurements of airway smooth muscle area / thickness will be assessed during the bronchoscopy.

Secondary outcome [1]

Timepoint [1]

Eligibility

Key inclusion criteria

Participants will be Patients undergoing bronchoscopy for clinical purposes.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Unable to complete questionnaires (language or intellectual difficulties).
2. Central airway obstruction due to tumour or foreign body.
3. Generalised lung disease (e.g. pneumonia, interstitial lung disease, pneumonitis, bronchiectasis or widespread pulmonary infiltrates.
4. Significant concurrent medical illness or treatment with systemic effects (e.g. cardiac disease, cancer, chemotherapy, pulmonary fibrosis).
5. Pregnant women

Study design

Purpose

Natural history

Duration

Cross-sectional

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

14/06/2022

Date of last participant enrolment

Anticipated

31/03/2025

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Fiona Stanley Hospital - Murdoch

Recruitment hospital [2]

Sir Charles Gairdner Hospital - Nedlands

Recruitment postcode(s) [1]

6150 - Murdoch

Recruitment postcode(s) [2]

6009 - Nedlands

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC)

Address [1]

16 Marcus Clarke Street, Canberra ACT 2601

Country [1]

Australia

Funding source category [2]

University

Name [2]

The University of Western Australia

Address [2]

35 Stirling Highway, CRAWLEY
6009, Western Australia

Country [2]

Australia

Funding source category [3]

Hospital

Name [3]

Sir Charles Gairdner Hospital

Address [3]

Hospital Avenue, Nedlands 6009, Western Australia

Country [3]

Australia

Primary sponsor type

University

Name

The University of Western Australia

Address

35 Stirling Highway, CRAWLEY
6009, Western Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sir Charles Gairdner and Osborne Park Health Care HREC

Ethics committee address [1]

Hospital Avenue, Nedlands 6009,Western Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

06/03/2019

Ethics approval number [1]

Summary

Brief summary

In people with asthma, there is more muscle around the airways. The greater the amount of muscle, the more severe the asthma. In this project, we are testing a new method to measure airway smooth muscle around patients' airways during a bronchoscopy using light.   Measurements will be made in a number of airways in a number of patients to provide information about the reliability of this technique, particularly how much it varies between airways within the same patient and between patients. It can then be used to improve current treatments and develop new treatments aimed at the increased smooth muscle in asthma.

During the bronchoscopy, measurements will be made through the bronchoscope using a laser beam.  The bronchoscopists involved will be taking the measurements. This will probably add 10-15min extra to the duration of the procedure. The equipment required for this procedure is a PS-OCT system (packaged in a trolley); a flexible fibre-optic endoscopic probe and a sterile sealed transparent tubing for use during the bronchoscopy.

Trial website

Trial related presentations / publications

Public notes

The incidence of adverse events will not be assessed as an outcome in this study.

Contacts

Principal investigator

Name

Prof Alan L James

Address

Department of Pulmonary Physiology and Sleep Medicine
5th Floor, G Block
Sir Charles Gairdner Hospital
Hospital Ave, Nedlands WA 6009

Country

Australia

Phone

+61 0864883314

Fax

Alan.James2@health.wa.gov.au

Contact person for public queries

Name

Alvenia Cairncross

Address

School of Human Sciences,
The University of Western Australia, 35 Stirling Highway, Crawley, Western Australia 6009

Country

Australia

Phone

+61 0864883302

Fax

alvenia.cairncross@uwa.edu.au

Contact person for scientific queries

Name

Peter B Noble

Address

School of Human Sciences, The University of Western Australia, 35 Stirling Highway, Crawley, Western Australia 6009

Country

Australia

Phone

+61 0864883302

Fax

peter.noble@uwa.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Potentially all of the individual participant data collected during the trial; after de-identification.

When will data be available (start and end dates)?

Beginning 3 months and ending 5 years following main results publication.

Available to whom?

Only researchers who provide a methodologically sound proposal and case-by-case basis at the discretion of the study investigators.

Available for what types of analyses?

This will be based on a case-by-case basis at the discretion of the study investigators when a sound research design is provided to the study investigators.

How or where can data be obtained?

Access subject to approvals by the Study investigators on an appropriate data sharing platform. Please contact Associate Professor Peter B Noble at +61 8 6488 3302 [peter.noble@uwa.edu.au] OR Clinical Professor Alan James +61 8 6457 2888
[alj@westnet.com.au]

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
16709	Informed consent form			peter.noble@uwa.edu.au
16710	Ethical approval			peter.noble@uwa.edu.au

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.

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