Gala FIH Feasibility Study for the Treatment of Chronic Bronchitis

Study Overview
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Brief Summary
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Feasibility trial (FIH) to assess the safety and clinical utility in patients with chronic bronchitis.

Detailed Description
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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. 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.

Official Title
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A Feasibility Study: A Safety Evaluation of the Gala Airway Treatment System on Patients With Chronic Bronchitis

Conditions
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Chronic Bronchitis

Intervention / Treatment
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* Device: Gala Airway Treatment System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 CAT must sum to at least 7 points. Subject has GOLD Stage II chronic obstructive pulmonary disease (COPD) with a preprocedure post-bronchodilator FEV1 of greater than or equal to 30% and less than or equal to 80% of predicted within three months of enrollment. Subjects with a preserved function (FEV1 > 80%) are allowed if the subject has a total CAT score greater than or equal to 10 and the sum of the first two questions of the CAT score sum to at least 7 points. Subject has a cigarette smoking history of at least ten packs years. Subject in the opinion of the site investigator is able to adhere to and undergo three bronchoscope procedures inclusive of lung biopsies and Gala treatments and has provided a signed informed consent. Exclusion Criteria: Subject has active respiratory infection (e.g., common cold, pneumonia, MAI, tuberculosis) or COPD exacerbation within the last 6 wees prior to study treatment bronchscopy. Subject is treated with > 10 mg of prednisolone or prednisone per day. Subject has an implantable cardioverter defibrillator or pacemaker. 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. 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 and 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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: Treatment with Gala Airway Treatment System (RheOx)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with GATS<br>Gala Airway Treatment System (GATS) / RheOx | Device: Gala Airway Treatment System<br>* 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. In this study, 2 treatment sessions will be delivered 1 month apart. The right lung is treated at the first treatment session and the left lung is treated at the second treatment session. A third bronchoscopy will be performed 3 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.<br>* Other names: RheOx;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence and evaluation of any serious adverse events associated with the Gala Airway Treatment System through 6 months. | Incidence and evaluation of any serious adverse events associated with the Gala Airway Treatment System through 6 months. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Utility - Histology | Histopathological evidence of change in mucus producing cells within the airway. | 3 months following bilateral treatment | 
| Clinical Utility - Pulmonary Function | Pulmonary function testing (PFT) utilizing Forced Expiratory Volume (FEV1) | Through end of study (12-months post-bilateral treatment) | 
| Quality of Life - COPD Assessment Test (CAT) | COPD Assessment Test (CAT) questionnaire | Through end of study (12-months post-bilateral treatment) | 
| Quality of Life - SGRQ | Patient filled respiratory questionnaire: St. George Respiratory Questionnaire (SGRQ) | Through end of study (12-months post-bilateral treatment) | 
| Acute Exacerbations | Detection of acute exacerbations (measured by clinical examination of a suitably qualified physician) | From 48 hours post procedure through end of study (12 months post-bilateral treatment) | 
| Non-Acute Exacerbations | Detection of non-acute exacerbations (measured by clinical examination of a suitably qualified physician) | From 48 hours post procedure through end of study (12 months post-bilateral treatment) | 
| Six Minute Walk Test (6MWT) | Change in 6MWT at 6 months compared to baseline | 6 months post-bilateral treatment |