A Study to Evaluate RheOx Bronchial Rheoplasty System to Treat Chronic Bronchitis in Adults with COPD

Overview

About this study

The purpose of this study is to assess the safety and effectiveness of Bronchial Rheoplasty for the treatment of the symptoms of chronic bronchitis in adult COPD patients with moderate to severe chronic bronchitis.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Patient is at least 35 years of age.
  • Patient has 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.
  • Patient has a CAT score ≥ 10.
  • Patient has an SGRQ score ≥ 25.
  • Patient’s responses to the first two questions of the CAT instrument sum to ≥ 7 points or the sum is 6 points and the patient’s total CAT score is > 20 points.
  • Patient has FEV1/FVC < 0.7.
  • Patient has a pre-procedure post-bronchodilator FEV1 percent predicted of ≥ 30%.
  • Patient is 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.
  • Patient has a cigarette smoking history of at least ten pack years.
  • In the opinion of the Primary Investigator, patient is able to undergo 2 bronchoscopies under general anesthesia and is able to adhere to the study follow-up schedule.
  • Patient has provided informed consent.

Exclusion Criteria:

  • Patient has known unresolved lower respiratory tract infection (e.g., pneumonia, mycobacterium avium-intracellulare infection (MAI), fungus, tuberculosis).
  • Patient has a steroid-dependent condition requiring > 10 mg of oral corticosteroid per day.
  • Patient has any implantable electronic device (e.g., pacemaker, cardioverter defibrillator, neuro-stimulation devices).
  • Patient has 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.
  • Patient has unresolved lung cancer.
  • Patient has a pulmonary nodule or cavity that in the judgement of the Primary investigator may require intervention during the course of the study.
  • Patient 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.
  • Patient has emphysema of greater than or equal to 20% as quantified on baseline HRCT scan (low attenuation area less than -950HU) as determined by the CT Core Lab.
  • Patient has asthma based on Global Initiative for Asthma (GINA) criteria.
  • Patient has clinically significant bronchiectasis influencing the patient’s clinical symptoms of cough and phlegm.
  • Patient has actively smoked (including tobacco, marijuana, e-cigarettes, vaping, etc.) within the last 6 months.
  • Patient is unable to walk over 225 meters in 6 minutes.
  • Patient has a serious medical condition that, in the Primary investigator’s opinion, could compromise patient safety or confound the interpretation of the patient’s response to therapy (e.g., congestive heart failure, cardiomyopathy, or myocardial infarction in the past year, renal failure, liver disease cerebrovascular accident within the past 6 months, uncontrolled diabetes (HbA1c > 8%), uncontrolled hypertension (diastolic BP > 100mmHg) or autoimmune disease requiring treatment with immunosuppressant medications or a disease requiring chemotherapy).
  • Patient has uncontrolled GERD.
  • Patient has known severe pulmonary hypertension.
  • Patient has a known sensitivity to medication required to perform bronchoscopy (i.e., lidocaine, atropine, benzodiazepines).
  • Patient is pregnant, nursing, or planning to get pregnant during study duration.
  • Patient is currently participating in another clinical study involving an investigational product.
  • Patient is on anticoagulation for cardiovascular indications and, at the discretion of the Primary investigator, is unable to have anticoagulants (i.e., Aspirin, Plavix, Coumadin) withheld for the bronchoscopy procedure per institution’s standard of care.
  • Patient has known airway colonization with resistant organisms, such as pseudomonas, methicillin-resistant Staphylococcus aureus (MRSA), Burkholderia cepacia complex, Mycobacterium Tuberculosis (MTB), Mycobacterium abscessus mucor or significant fungus.
  • Patient has had prior severe respiratory infection with SARS-CoV-2 (COVID-19) that required ICU support with non-invasive and/or invasive mechanical ventilation.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ryan Kern, M.D.

Open for enrollment

Contact information:

Brandon Clapp

(507) 284-2122

Clapp.Brandon@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Sebastian Fernandez-Bussy, M.D.

Open for enrollment

Contact information:

Caroline Chang

(904) 953-4637

Chang.Caroline@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20516079

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