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Clinical Study of the RheOx Bronchial Rheoplasty System in Treating the Symptoms of Chronic Bronchitis (RheSolve)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04677465
Recruitment Status : Recruiting
First Posted : December 21, 2020
Last Update Posted : February 23, 2023
Sponsor:
Information provided by (Responsible Party):
Gala Therapeutics, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Bronchitis Device: RheOx Bronchial Rheoplasty Device: Sham Procedure Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel group design randomizing patients in a 2:1 ratio to the treatment vs. sham group. Randomization will be blocked and stratified by site and FEV1 (<50% vs. >/= 50%)
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 7, 2021
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: RheOx Treatment Device: RheOx Bronchial Rheoplasty
bronchial rheoplasty is a staged procedure wherein pulsed electric fields are delivered to the right lung in the first treatment visit, and then the left lung is treated approximately 1 month later.
Sham Comparator: Sham Procedure Device: Sham Procedure
staged sham procedure wherein bronchoscopy is performed, the catheter is inserted into the right lung, but energy is not delivered; then the same steps are performed in the left lung approximately 1 month later (no energy is delivered to the patient)


Outcome Measures
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Primary Outcome Measures :
  1. COPD Assessment Test (CAT) Score [ Time Frame: 6 months ]
    Mean change from baseline in the COPD Assessment Test (CAT) total score, the total CAT score ranges from 0 to 40, where lower scores represent lower symptom burden


Secondary Outcome Measures :
  1. Distal Airway Volume [ Time Frame: 6 months ]
    Change from baseline distal airway volume (DAV) at expiration using HRCT scans

  2. COPD Exacerbations [ Time Frame: 12 months ]
    Rate of moderate and severe COPD exacerbations

  3. Goblet Cell Hyperplasia [ Time Frame: 1 month ]
    change from baseline in mean goblet cell hyperplasia score as determined from airway biopsy samples; the grading scale ranges from 0 to 3, where lower scores represent less goblet cell hyperplasia

  4. Cough Frequency [ Time Frame: 6 and 12 months ]
    change from baseline in cough frequency (coughs/hour in a 24-hour recording period)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 < 0.70.
  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, unless the patient has attempted such therapy within the past 1 year without significant clinical response or had an adverse reaction.
  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

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) that cannot be turned off during the procedure.
  4. Patient has a history of ventricular tachy-arrhythmia or clinically significant atrial tachyarrhythmia within the past two years, unless the arrhythmia has been treated and/or patient is in regular rhythm during the screening phase.
  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 25% 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04677465


Contacts
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Contact: Brett Bannan 408-623-8104 brett@galatherapeutics.com
Contact: Cindy Holtz 651-338-0457 choltz@galatherapeutics.com

Locations
Show Show 44 study locations
Sponsors and Collaborators
Gala Therapeutics, Inc.
Investigators
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Principal Investigator: Frank Sciurba, MD UPMC; Division of Pulmonary and Critical Care Medicine
Principal Investigator: Arschang Valipour, MD Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology; Vienna, Austria
More Information
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Responsible Party: Gala Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04677465    
Other Study ID Numbers: CSP-00006
First Posted: December 21, 2020    Key Record Dates
Last Update Posted: February 23, 2023
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Gala Therapeutics, Inc.:
COPD
Additional relevant MeSH terms:
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Bronchitis
Bronchitis, Chronic
Acute Disease
Respiratory Tract Infections
Infections
Bronchial Diseases
 Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Disease Attributes
Pathologic Processes
Pulmonary Disease, Chronic Obstructive