Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001075875
Ethics application status
Approved
Date submitted
12/04/2021
Date registered
16/08/2021
Date last updated
16/08/2021
Date data sharing statement initially provided
16/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Bronchial Thermoplasty in Chronic Obstructive Airways Disease
Scientific title
Pilot study of the safety and effectiveness of bronchial thermoplasty in patients with Chronic Obstructive Pulmonary Disease ages 40 to 80 years in age
Secondary ID [1] 303939 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD 321525 0
Condition category
Condition code
Respiratory 319280 319280 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will undergo general aneasthesia on 3 occasions over a 3 month period, and on each occasion a different portion of the lung will be treated by the bronchoscopic procedure called bronchial thermoplasty. During this procedure, a small videocamera will be passed down the wind pipe, under anaesthesia, to inspect the airways. Then, a radiofrquency catheter will be introduced through the instrument to apply 10 second bursts of low energy heat to the airways to weaken the airway muscle. It is this muscle which causes constriction and wheezing.This procedure will be performed by Prof David Langton, who is an expert in this treatment. Each procedure takes about 40 minutes in total
Intervention code [1] 320242 0
Treatment: Surgery
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327156 0
The main outcome measure will be assessing change in airway calibre measured by CT scanning comparing pre with post treatment
Timepoint [1] 327156 0
Pretreatment and then 6 months post treatment
Secondary outcome [1] 395189 0
Change in prebronchodilator Forced Expiratory Volume in 1 second, assessed by spirometry, comparing pre treatment with post treatment
Timepoint [1] 395189 0
Comparing 6 months post treatment with pre treatment
Secondary outcome [2] 397786 0
Change in COPD CAT score questionnaire
Timepoint [2] 397786 0
comparing 6 months post treatment with baseline

Eligibility
Key inclusion criteria
1 A cigarette smoking pack year history of 20 plus pack years
2 A respiratory physician diagnosis of COPD
3 A baseline FEV1 of greater than 40% predicted (so as to avoid very severe patients in case of wheezing post procedure)
4 A baseline FEV1 of less than 60% predicted (so there is no doubt about the diagnosis)
5 Using triple inhaler therapy (ie maximal bronchodilators)
6 Age >40 but <80 years
7 If female of child-bearing potential, must be using highly effective contraception
8 Resting oxygen saturation by pulse oximetry greater than 90%
9 Able and willing to provide informed consent
10 A history of exacerbations in the previous 12 months including either at least one hospital admission for COPD, or at least two oral corticosteroid requiring exacerbations.
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1 Treated with domiciliary oxygen or non-invasive ventilation
2 Poor cardiac function on echocardiogram, or pulmonary artery pressure greater than 50 mmHg
3 Active malignancy
4 Poor renal function or the need for dialysis
5 Active history of angina or myocardial infarction within last 12 months
6 Unable to achieve a 6 minute walking distance of 150metres
7 Has a Pacemaker in situ or other contraindication to radiofrequency treatment
8 BMI greater than 35 or less than 18 kg/m2
9. Two or more body CT scans in the 12 months prior to study participation

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2021
Actual
Date of last participant enrolment
Anticipated
1/09/2023
Actual
Date of last data collection
Anticipated
1/06/2024
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 308322 0
Hospital
Name [1] 308322 0
Frankston Hospital
Country [1] 308322 0
Australia
Primary sponsor type
Hospital
Name
Frankston Hospital
Address
2 Hastings Rd Frankston
Victoria
3199
Country
Australia
Secondary sponsor category [1] 309134 0
None
Name [1] 309134 0
Address [1] 309134 0
Country [1] 309134 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308297 0
Peninsula Health Human Research Ethics Committee
Ethics committee address [1] 308297 0
Ethics committee country [1] 308297 0
Australia
Date submitted for ethics approval [1] 308297 0
Approval date [1] 308297 0
18/01/2021
Ethics approval number [1] 308297 0

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

Contacts
Principal investigator
Name 110222 0
Prof David Langton
Address 110222 0
Peninsula Health
2 Hastings Rd Frankston
Victoria
3199
Country 110222 0
Australia
Phone 110222 0
+61 3 97847777
Fax 110222 0
Email 110222 0
[email protected]
Contact person for public queries
Name 110223 0
David Langton
Address 110223 0
Peninsula Health
2 Hastings Rd Frankston
Victoria
3199
Country 110223 0
Australia
Phone 110223 0
+61 97847777
Fax 110223 0
Email 110223 0
[email protected]
Contact person for scientific queries
Name 110224 0
David Langton
Address 110224 0
Peninsula Health
2 Hastings Rd Frankston
Victoria
3199
Country 110224 0
Australia
Phone 110224 0
+61 3 97847777
Fax 110224 0
Email 110224 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
Confidentiality of participants


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.