RheSolve Study: Investigational device for the treatment of cough and phlegm

Inclusion Criteria

• •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.

Exclusion Criteria

• •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.

Additional Info

• 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