RecruitingACTRN12617000330347

A Feasibility Study: A Safety Evaluation of the Gala Airway Treatment System on Patients with Chronic Bronchitis in Australia

Sponsor

Gala Therapeutics Inc.

Enrollment

24 participants

Start Date

Mar 7, 2017

Study Type

Interventional

Conditions

Bronchitis Emphysema

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.

Eligibility

Sex: Both males and femalesMin Age: 40 Yearss

Inclusion Criteria3

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.
Subject’s responses to the first two questions of the COPD Assessment Test (CAT) must sum to at least 7 points.
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.

Exclusion Criteria18

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..
Subject has an implantable cardioverter defibrillator or pacemaker.
Subject is taking greater than 10mg of prednisolone per day.
Subject has a history of cardiac arrhythmia within past two years.
Subject has abnormal cardiac rhythm at time of procedure.
Subject has history of proven lung cancer in last 5 years.
Subject has pulmonary nodule or cavity requiring follow-up or intervention unless proven benign and not actively infected (e.g., aspergilloma).
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
Subject has Alpha-1-Antitrypsin (AAT) deficiency.
Subject has documented history of asthma diagnosed with onset <30 years of age, clinically significant bronchiectasis or any other significant second lung disease.
Subject actively smoked (including tobacco, marijuana, e-cigarettes, vaping, etc.) within the last 6 months.
Subject has the inability to walk over 140 meters.
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.
Subject has known sensitivity to medication required to perform bronchoscopy (such as lidocaine, atropine, and benzodiazepines).
Subject is pregnant, nursing, or planning to get pregnant during study duration.
Subject has received chemotherapy within the past 6 months or is expected to receive chemotherapy during participation in this study.
Subject is or has been in another clinical investigational study within 6 weeks of baseline.
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.

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Interventions

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 de

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.