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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
17/09/2023
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] 307102 0
None
Universal Trial Number (UTN)
Trial acronym
HASMA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 326262 0
Condition category
Condition code
Respiratory 323566 323566 0 0
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] 323552 0
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] 331339 0
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] 331339 0
Measurements of airway smooth muscle area / thickness will be assessed during the bronchoscopy.
Primary outcome [2] 332213 0
We also aim to measure the area of airway smooth muscle in the smaller airways using endoscopic polarisation-sensitive optical coherence tomography
Timepoint [2] 332213 0
Measurements of airway smooth muscle area / thickness will be assessed during the bronchoscopy.
Secondary outcome [1] 409560 0
NA
Timepoint [1] 409560 0
NA

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?
No
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
31/03/2024
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
11
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 22763 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [2] 22764 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 38044 0
6009 - Nedlands
Recruitment postcode(s) [2] 38043 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 311409 0
Government body
Name [1] 311409 0
National Health and Medical Research Council (NHMRC)
Country [1] 311409 0
Australia
Funding source category [2] 311792 0
University
Name [2] 311792 0
The University of Western Australia
Country [2] 311792 0
Australia
Funding source category [3] 311793 0
Hospital
Name [3] 311793 0
Sir Charles Gairdner Hospital
Country [3] 311793 0
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] 312798 0
None
Name [1] 312798 0
Address [1] 312798 0
Country [1] 312798 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310888 0
Sir Charles Gairdner and Osborne Park Health Care HREC
Ethics committee address [1] 310888 0
Hospital Avenue, Nedlands 6009,Western Australia
Ethics committee country [1] 310888 0
Australia
Date submitted for ethics approval [1] 310888 0
Approval date [1] 310888 0
06/03/2019
Ethics approval number [1] 310888 0

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 119238 0
Prof Alan L James
Address 119238 0
Department of Pulmonary Physiology and Sleep Medicine
5th Floor, G Block
Sir Charles Gairdner Hospital
Hospital Ave, Nedlands WA 6009
Country 119238 0
Australia
Phone 119238 0
+61 0864883314
Fax 119238 0
Email 119238 0
Alan.James2@health.wa.gov.au
Contact person for public queries
Name 119239 0
Dr Alvenia Cairncross
Address 119239 0
School of Human Sciences,
The University of Western Australia, 35 Stirling Highway, Crawley, Western Australia 6009
Country 119239 0
Australia
Phone 119239 0
+61 0864883302
Fax 119239 0
Email 119239 0
alvenia.cairncross@uwa.edu.au
Contact person for scientific queries
Name 119240 0
A/Prof Peter B Noble
Address 119240 0
School of Human Sciences, The University of Western Australia, 35 Stirling Highway, Crawley, Western Australia 6009
Country 119240 0
Australia
Phone 119240 0
+61 0864883302
Fax 119240 0
Email 119240 0
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.TypeCitationLinkEmailOther DetailsAttachment
16709Informed consent form  peter.noble@uwa.edu.au
16710Ethical approval  peter.noble@uwa.edu.au



Results publications and other study-related documents

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