A Study for those with COPD and Chronic Bronchitis
Purpose
RheOx (Gala Therapeutics, Inc.) is an investigational device designed to reduce cough and mucus production through a minimally-invasive procedure. The procedure is performed through a bronchoscope, a thin flexible tube that is inserted through the mouth into the lungs. Once in place, RheOx delivers short bursts of electrical energy to the inner walls of the bronchi, eliminating the mucus-producing cells. Over the next several days, new cells grow and produce less mucus. The right lung is treated first, followed by treatment of the left lung about 1 month later.
RheOx has been studied in three clinical trials and has shown a significant improvement in quality of life and a reduction in cough and mucus at 12 months.
Could this study be right for you?
You may be eligible if:
-You are at least 35 years of age.
-Have chronic bronchitis, defined as productive cough for three months in each of two successive years, whereas other causes of productive cough have been ruled out
-You are receiving guideline directed pharmacotherapy which includes one or more long acting bronchodilator (LAMA, LABA) with or without an inhaled corticosteroid for at least 8 weeks prior to randomization
-You have a cigarette smoking history of at least ten pack years.
-Other criteria that will be reviewed by the study team
You will not be eligible if you have:
- A known unresolved lower respiratory tract infection (e.g., pneumonia, mycobacterium avium-intracellulare infection (MAI), fungus, tuberculosis).
- A steroid-dependent condition requiring more than 10 mg of oral corticosteroid per day.
- Any implantable electronic device (e.g., pacemaker, cardioverter defibrillator, neuro-stimulation devices).
- A history of arrhythmia within past two years which includes tachy-atrial arrhythmias, any ventricular tachy-arrhythmias, or sinus bradycardia with heart rate less than 45 beats per minute.
- Unresolved lung cancer.
- A pulmonary nodule or cavity that in the judgement of the Primary investigator may require intervention during the course of the study.
- Had prior lung surgery, such as lung transplant, LVRS, lobectomy, lung implant/prosthesis, metal airway stent, valves, coils or bullectomy. Prior pneumothorax without lung resection, pleural procedures without surgery, or segmentectomy are acceptable.
- Asthma based on Global Initiative for Asthma (GINA) criteria.
- Smoked (including tobacco, marijuana, e-cigarettes, vaping, etc.) within the last 6 months.
- Unable to walk over 238 feet in 6 minutes.
- Uncontrolled GERD.
- Had prior severe respiratory infection with SARS-CoV-2 (COVID-19) that required ICU support with non-invasive and/or invasive mechanical ventilation.
- A known allergy to nickel.
- Other criteria will be reviewed by the study team