Clinical trial NCT04677465: Clinical Study of the RheOx Bronchial Rheoplasty System in Treating the Symptoms of Chronic Bronchitis
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Bronchitis
Keywords: COPD
Lead sponsor: Gala Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-21
Enrollment: 270
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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%)
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: COPD Assessment Test (CAT) Score
timeFrame: 6 months
Secondary outcomes:
measure: Distal Airway Volume
timeFrame: 6 months
measure: COPD Exacerbations
timeFrame: 12 months
measure: Goblet Cell Hyperplasia
timeFrame: 1 month
measure: Cough Frequency
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Norton Thoracic
state: Arizona
city: Scottsdale
country: United States
facility: Honor Health
state: Arizona
city: Bakersfield
country: United States
facility: Syed M. Alam, MD Pulmonology (Bakersfield Heart)
state: California
city: Davis
country: United States
facility: UC Davis Medical Center
state: California
city: Encinitas
country: United States
facility: Scripps Health
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Torrance
country: United States
facility: UCLA Harbor Lundquist Institute
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Tallahassee
country: United States
facility: The Cardiac and Vascular Institute Research Foundation
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Peoria
country: United States
facility: OSF Saint Francis Medical Center
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas School of Medicine
state: Kansas
city: New Orleans
country: United States
facility: Tulane University Medical Center
state: Louisiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Hospital and Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Minnesota Lung Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi
state: Mississippi
city: Pinehurst
country: United States
facility: Pinehurst Medical Clinic
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Chattanooga
country: United States
facility: CHI Memorial Research Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Fort Worth
country: United States
facility: JPS Health Network, Fort Worth
state: Texas
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University Health
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Vienna
country: Austria
facility: Klinik Floridsdorf - Abteilung für Innere Medizin und Pneumologie
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin, Campus Virchow Klinikum
city: Essen
country: Germany
facility: Ruhrlandklinik Essen
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg
city: Brescia
country: Italy
facility: ASST Spedali Civili Hospital
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
affiliation: UPMC; Division of Pulmonary and Critical Care Medicine
name: Frank Sciurba, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology; Vienna, Austria
name: Arschang Valipour, MD
role: PRINCIPAL_INVESTIGATOR
References: