Summary

Eligibility
for people ages 35 years and up (full criteria)
Location
at Davis, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Ken Yoneda, MD

Description

Summary

This is a prospective, randomized, parallel group, double-blind, sham-controlled, multicenter clinical trial following patients to 2 years. The objective 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. A total of 270 patients will be randomized at up to 40 study centers in the United States, Canada, and Europe.

Official Title

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

Keywords

Chronic Bronchitis COPD Bronchitis Bronchitis, Chronic Acute Disease RheOx Bronchial Rheoplasty

Eligibility

You can join if…

Open to people ages 35 years and up

  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

You CAN'T join if...

  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

Locations

  • UC Davis Medical Center accepting new patients
    Davis California 95817 United States
  • Syed M. Alam, MD Pulmonology (Bakersfield Heart) accepting new patients
    Bakersfield California 93309 United States

Lead Scientist at UC Davis

  • Ken Yoneda, MD
    Professor, Pulmonary, Critical Care, and Sleep Medicine. Authored (or co-authored) 52 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gala Therapeutics, Inc.
Links
Sign up for this study
ID
NCT04677465
Study Type
Interventional
Last Updated