A Clinical Evaluation of the RheOx Bronchial Rheoplasty System for the Treatment of the Symptoms of Chronic Bronchitis in Adult Patients with COPD

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

1. Patient is at least 35 years of age.
2. 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.
3. Patient has a CAT score >= 10.
4. Patient has an SGRQ score >= 25.
5. 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.
6. Patient has FEV1/FVC < 0.7.
7. Patient has a pre-procedure post-bronchodilator FEV1 percent predicted of >=
30%.
8. 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
9. Patient has a cigarette smoking history of at least ten pack years.
10. 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.
11. Patient has provided informed consent.

Exclusion Criteria

1. Patient has known unresolved lower respiratory tract infection (e.g.,
pneumonia, mycobacterium avium-intracellulare infection (MAI), fungus,
tuberculosis).
2. Patient has a steroid-dependent condition requiring >10 mg of oral
corticosteroid per day.
3. Patient has any implantable electronic device (e.g., pacemaker, cardioverter
defibrillator, neuro-stimulation devices).
4. 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.
5. Patient has unresolved lung cancer.
6. Patient has a pulmonary nodule or cavity that in the judgement of the
Primary investigator may require intervention during the course of the study.
7. 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.
8. 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.
9. Patient has asthma based on Global Initiative for Asthma (GINA) criteria.
10. Patient has clinically significant bronchiectasis influencing the patient*s
clinical symptoms of cough and phlegm.
11. Patient has actively smoked (including tobacco, marijuana, e-cigarettes,
vaping, etc.) within the last 6 months.
12. Patient is unable to walk over 225 meters in 6 minutes.
13. 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).
14. Patient has uncontrolled GERD.
15. Patient has known severe pulmonary hypertension.
16. Patient has a known sensitivity to medication required to perform
bronchoscopy (i.e., lidocaine, atropine, benzodiazepines).
17. Patient is pregnant, nursing, or planning to get pregnant during study
duration.
18. Patient is currently participating in another clinical study involving an
investigational product.
19. 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.
20. 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.
21. 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.
22. Patient has known allergy to nickel.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy endpoint is the mean change from baseline to Month 6 in<br /><br>the COPD Assessment Test (CAT) total score.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary efficacy endpoints include both objective measures and subjective,<br /><br>patient reported measures.<br /><br>Objective Measures:<br /><br>• Change from baseline to Month 6 in distal airway volume (DAV) at expiration<br /><br>as determined by an independent core lab<br /><br>• Rate of moderate and severe COPD exacerbations through Month 12, excluding<br /><br>the two 30-day treatment recovery periods<br /><br><br /><br>Patient Reported Outcome Measures:<br /><br>• CAT:<br /><br>mean total scores at months 3 and 12<br /><br>responder analyses at months 3, 6, and 12<br /><br>• CAT Components 1 and 2, and their sum: mean total scores and responder<br /><br>analyses at months 3, 6, and 12<br /><br>• SGRQ: mean total scores and responder analyses at months 6 and 12<br /><br>• CASA-Q: mean total scores in each domain at months 6 and 12</p><br>

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