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Trial registered on ANZCTR


Registration number
ACTRN12617000330347
Ethics application status
Approved
Date submitted
24/02/2017
Date registered
2/03/2017
Date last updated
30/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A Feasibility Study: A Safety Evaluation of the Gala Airway Treatment System on Patients with Chronic Bronchitis in Australia
Scientific title
A Feasibility Study: A Safety Evaluation of the Gala Airway Treatment System on Patients with Chronic Bronchitis in Australia
Secondary ID [1] 291269 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchitis 302210 0
Emphysema 302211 0
Condition category
Condition code
Respiratory 301814 301814 0 0
Chronic obstructive pulmonary disease
Respiratory 301815 301815 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Gala Airway Treatment system will be used to deliver treatment to all participants enrolled in the trial (single arm - no blinding).
The Gala Airway Treatment system is a device-based, energy delivery system that delivers high frequency short duration energy to the airway epithelium and sub-mucosal tissue layers. The energy is delivered via a proprietary catheter through the bronchoscope.
Two sessions of treatment will be delivered one month apart. Energy of 2500 volts will be delivered to the airways in very short bursts between 25 to 55 times per lung. The right lung is treated at the first treatment session and the left lung is treated at the second treatment session (approximately one month after the right side is treated). Treatment will be delivered by a respiratory physician (interventional pulmonologist) in a tertiary teaching hospital during a bronchoscopic procedure. The bronchoscopy will be delivered during general anaesthesia. It is anticipated that the bronchoscopic procedure will last less than 60 minutes in total. Treatment will be deemed to have been delivered following the successful treatment during the two bronchoscopies.
A third bronchoscopy will be performed three months following the second treatment session where treatment is not delivered but a cryo-biopsy will be taken from the airway sites that have been treated during the two previous bronchoscopic treatment session to evaluate the effect of the treatment on the airways producing excessive mucous.
Subjects will be required to submit to several tests during the study including two CT scans (lung), respiratory function tests, exercise testing.
Intervention code [1] 297286 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301227 0
The primary outcome is safety as assessed by the incidence and evaluation of any serious adverse events associated with the Gala Airway Treatment System through 6 months. Included in this assessment will be the proportion of subjects with any of the following outcomes: (1) death, or (2) medical morbidity including but not limited to exacerbations of COPD, pneumonia, pneumothorax, arrhythmia. Patients will be followed through completion of follow-up.
Timepoint [1] 301227 0
6 months post delivery of Treatment number 2.
Secondary outcome [1] 332065 0
The secondary outcome clinical utility will be assessed by histopathological evidence of change in mucus producing cells within the airway.
Timepoint [1] 332065 0
12 months following treatment session number 2
Secondary outcome [2] 332172 0
Clinical utility will also be assessed by pulmonary function testing utilising the FEV1 and FVC tests.
Timepoint [2] 332172 0
Pulmonary function testing measured at treatment number 2 and, 3 months, 6 months and 12 months post treatment number 2
Secondary outcome [3] 332173 0
Quality of Life Indices will be measured via patient filled respiratory questionnaires (SGRQ, CAT)
Timepoint [3] 332173 0
Quality of Life Indices will be completed at treatment 2, and 3 months, 6 months and 12 months post treatment 2
Secondary outcome [4] 332282 0
Detection of acute exacerbations (measured by clinical examination of a suitably qualified physician)
Timepoint [4] 332282 0
Between 48 hours post procedure (1st or 2nd treatment procedures and 3rd biopsy procedure) and the end of the patient's participation in the study
Secondary outcome [5] 332283 0
Determination of procedural success measured by the effective delivery of the treatment by the Airway Treatment System.
Timepoint [5] 332283 0
At the conclusion of Treatment session 1 and Treatment session 2.
Secondary outcome [6] 347519 0
Six Minute Walk Test
Timepoint [6] 347519 0
At 6 months following the completion of treatment 2.

Eligibility
Key inclusion criteria
1. Subject is diagnosed with chronic bronchitis for a minimum of two years, where chronic bronchitis is defined clinically as chronic productive cough for three months in each of two successive years in a patient in whom other causes of productive cough have been excluded.
2.Subject’s responses to the first two questions of the COPD Assessment Test (CAT) must sum to at least 7 points.
3. Subject has a pre-procedure, post-bronchodilator FEV1 of greater than or equal to 30% and less than or less than 80% of predicted within three months of enrollment. Subjects with preserved function (FEV1>80%) are allowed if the subject has a total CAT score = 10 and the sum of the first two questions on the CAT score sum to at least 7 points.
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Subject has active respiratory infection (e.g., common cold, pneumonia, MAI, tuberculosis) or COPD exacerbation within the last six weeks prior to the scheduled bronchoscopy..
2. Subject has an implantable cardioverter defibrillator or pacemaker.
3. Subject is taking greater than 10mg of prednisolone per day.
4. Subject has a history of cardiac arrhythmia within past two years.
5. Subject has abnormal cardiac rhythm at time of procedure.
6. Subject has history of proven lung cancer in last 5 years.
7. Subject has pulmonary nodule or cavity requiring follow-up or intervention unless proven benign and not actively infected (e.g., aspergilloma).
8. Subject has prior lung surgery, such as lung transplant, LVRS, lung implant/prosthesis, metal stent, valves, coils, bullectomy, segmentectomy, or lobectomy. Pneumothorax without lung resection is acceptable. Pleural procedures without surgery are acceptable. Patients who have had a valve removed more than 30 days prior to study screening may be enrolled provided the airway is sufficiently accessible for the Gala treatment
9. Subject has Alpha-1-Antitrypsin (AAT) deficiency.
10. Subject has documented history of asthma diagnosed with onset <30 years of age, clinically significant bronchiectasis or any other significant second lung disease.
11. Subject actively smoked (including tobacco, marijuana, e-cigarettes, vaping, etc.) within the last 6 months.
12. Subject has the inability to walk over 140 meters.
13. Subject has a serious medical condition, such as: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction in the past year, renal failure, liver disease, cerebrovascular accident within the past 6 months, uncontrolled diabetes, hypertension, autoimmune disease or uncontrolled gastric reflux.
14. Subject has known sensitivity to medication required to perform bronchoscopy (such as lidocaine, atropine, and benzodiazepines).
15. Subject is pregnant, nursing, or planning to get pregnant during study duration.
16. Subject has received chemotherapy within the past 6 months or is expected to receive chemotherapy during participation in this study.
17. Subject is or has been in another clinical investigational study within 6 weeks of baseline.
18. Subject on anticoagulation for cardiovascular indications is unable to have anticoagulants (i.e., Aspirin, Plavix, Coumadin) withheld for at least seven days prior to bronchoscopy in the opinion of the investigator.

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)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 7556 0
The Alfred - Prahran
Recruitment hospital [2] 7557 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 7558 0
Macquarie University Hospital - Macquarie Park
Recruitment postcode(s) [1] 15448 0
3004 - Prahran
Recruitment postcode(s) [2] 15449 0
3050 - Parkville
Recruitment postcode(s) [3] 15450 0
2109 - Macquarie Park

Funding & Sponsors
Funding source category [1] 295726 0
Commercial sector/Industry
Name [1] 295726 0
Gala Therapeutics Inc.
Address [1] 295726 0
230 Park Ave., Suite 2800 New York, NY 10169
Country [1] 295726 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Gala Therapeutics Inc.
Address
230 Park Ave., Suite 2800 New York, NY 10169
Country
United States of America
Secondary sponsor category [1] 294574 0
Commercial sector/Industry
Name [1] 294574 0
Medical Technology Services Pty Ltd
Address [1] 294574 0
PO Box 114 Pyrmont NSW 2009
Country [1] 294574 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297029 0
Macquarie University Human Research Ethics Committee (HREC (Medical Sciences)).
Ethics committee address [1] 297029 0
Research Office Research Hub, Building C5C East Macquarie University NSW 2109 Australia
Ethics committee country [1] 297029 0
Australia
Date submitted for ethics approval [1] 297029 0
08/11/2016
Approval date [1] 297029 0
12/12/2016
Ethics approval number [1] 297029 0
5201600725
Ethics committee name [2] 297031 0
The Alfred Hospital Human Research Ethics Committee
Ethics committee address [2] 297031 0
55 Commercial Road, Melbourne, VIC, 3004
Ethics committee country [2] 297031 0
Australia
Date submitted for ethics approval [2] 297031 0
31/08/2016
Approval date [2] 297031 0
22/12/2016
Ethics approval number [2] 297031 0
422/16

Summary
Brief summary
The Gala Therapeutics Airway Treatment System for Chronic Bronchitis in Australia will evaluate the safety and efficacy of the technology in up to 24 adult patients across three sites in Australia,
Patients with chronic bronchitis for a minimum of 2 years will be enrolled. Patients with a history of pacemaker / implantable defibrillator and cardiac arrhythmias as well as prior lung surgery, such as lung transplant, LVRS, lung implant/prosthesis, metal stent, valves, coils, bullectomy, segmentectomy, or lobectomy will not be considered for the trial Exception to this is patients who have had a valve removed greater than 30 days prior to being enrolled in the trial provided that the airway is sufficiently accessible for the Gala treatment.. The trial is single arm / non randomised (it is intended that each patient enrolled in the trial will receive the treatment under investigation) and is non blinded (patients and clinicians will be aware that the treatment is being delivered).
The trial will subject consented participants to treatment by the Gala Therapeutics Airway Treatment system over 2 bronchoscopies that will be performed by trained respiratory physicians (interventional pulmonologists) in tertiary teaching hospitals. Patients will be anaesthetised for these procedures. A third bronchoscopy will be performed in order to take airway biopsies to assess the effect of the treatment on the cells that produce mucous in the airways.
Subjects will also be required to undertake several tests during the study including 2 CT scans (Lung), respiratory function tests, exercise testing and blood tests. Subjects will be followed for 1 year following the second bronchoscopy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72762 0
Prof Gregory Snell
Address 72762 0
The Alfred Hospital
55 Commercial Road
Melbourne, VIC 3004
Country 72762 0
Australia
Phone 72762 0
+ 61 3 9076 2867
Fax 72762 0
+ 61 3 9076 3601
Email 72762 0
G.Snell@alfred.org.au
Contact person for public queries
Name 72763 0
Mr Matthew Godden
Address 72763 0
Australian Healthcare Solutions Pty Ltd
P.O. Box 3270
The Pines
Doncaster East, Victoria, 3109
Country 72763 0
Australia
Phone 72763 0
+ 61 400 007 127
Fax 72763 0
+ 61 3 9841 6993
Email 72763 0
matt@australianhealthcaresolutions.com.au
Contact person for scientific queries
Name 72764 0
Mr Jonathon Waldstreicher
Address 72764 0
Gala Therapeutics, Inc. (Corporate Headquarters)
230 Park Ave., Suite 2800
New York, NY 10169
Country 72764 0
United States Minor Outlying Islands
Phone 72764 0
+1 908 202 3732
Fax 72764 0
+1 212 468 5849
Email 72764 0
jon@galatherapeutics.com

No data has been provided for results reporting
Summary results
Not applicable