RheSolve Study: Investigational device for the treatment of cough and phlegm
- Trial ID:
- IRB-21-7771
- Samir Makani, MD
Inclusion Criteria
Patients must:- •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
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.
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
Contact Info:
- Laura Peluso
- peluso.laura@scrippshealth.org
- 760-230-8994