RheSolve Study: Investigational device for the treatment of cough and phlegm
Samir Makani, MD
This study is being done to evaluate the safety and effectiveness of an investigational treatment for reducing the symptoms of chronic bronchitis, like cough and phlegm. The treatment is called Bronchial Rheoplasty and uses an investigational device called RheOx™.
•Be 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 excluded.
•Be able to walk over 225 meters in 6 minutes.
•Be receiving one or more long-acting bronchodilator medications (e.g. LAMA, LABA) with or without an inhaled corticosteroid for at least 8 weeks.
•Have a cigarette smoking history of at least ten pack years and must have abstained from active smoking for a minimum of 6 months.
•Meet all other eligibility criteria.
Patients must not:
•Have unresolved lower respiratory tract infections, a steroid-dependent condition, or any implantable electronic device.
•Have a history of arrhythmia within past two years.
•Have lung cancer or prior lung surgery, such as lung transplant, LVRS, lobectomy, lung implant/prosthesis, metal airway stent, valves, coils or bullectomy.
•Have asthma, emphysema, or clinically significant bronchiectasis.
•Have actively smoked (including tobacco, marijuana, e-cigarettes, vaping, etc.) within the last 6 months.
•Be pregnant, nursing, or planning to get pregnant during study duration.
•Be currently participating in another clinical study involving an investigational product.
•Have known airway colonization with resistant organisms.
•Have known allergy to nickel.
Participants will be randomized to a treatment group (bronchial rheoplasty procedure) or control group (sham procedure).
For more information search for NCT04677465 at www.clinicaltrials.gov