RejuvenAir® System Trial for COPD With Chronic Bronchitis

NCT03893370 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 016
• Study Type: interventional
• Target: 210
• Locations: 2 countries
• Sites: 27

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) is defined as an impaired ability to move air within the lungs and is a major public health problem that is projected to rank fifth worldwide in terms of disease burden and third in terms of mortality. Chronic bronchitis (CB) is a common clinical phenotype within the umbrella of a COPD diagnosis and is classically defined as chronic cough and sputum production for 3 months a year for 2 consecutive years2, but many studies have used different definitions to define it- chronic cough and sputum production for one year or cough and sputum production on most days of the week. CB is associated with multiple clinical consequences, including; the worsening of lung function decline, increasing risk of acute exacerbations of COPD, increased risk of developing pneumonia, reduced health related quality of life, and an increase in all-cause mortality.

Conditions

Chronic Bronchitis

Outcome Measures

Primary Outcomes (1)

• St. George's Respiratory Questionnaire

  Change in St. George Respiratory Questionnaire (SGRQ) score from Baseline to 12 months

  12 months

Secondary Outcomes (5)

• Subjects experiencing serious adverse events (SAEs) rated as probably or definitely related to the study device or procedure

  Within 30 days after either the first or second study procedure

• Reduction of cough

  Baseline through 12 months

• Reduction of sputum

  Baseline through 12 months

• Acute Exacerbation Rate (AECOPD)

  12 months

• COPD assessment test (CAT) score

  12 months

Study Arms (2)

Treatment

ACTIVE COMPARATOR

RJA MCS

Device: RejuvenAir System

Sham Control

SHAM COMPARATOR

Sham

Device: Sham Control Procedure

Interventions

RejuvenAir System DEVICE

RejuvenAir Metered CryoSpray

Treatment

Sham Control Procedure DEVICE

Sham Control Procedure

Sham Control

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females ≥40 to ≤80 years of age
• Subject is able to read, understand, and sign a written Informed Consent in order to participate in the Study
• Subject has a diagnosis of chronic bronchitis (CB) and/or chronic obstructive pulmonary disease (COPD) for a minimum of two years. (Chronic Bronchitis is defined clinically as chronic productive cough for 3 months in each of 2 successive years in a patient in whom other causes of productive cough have been excluded)
• Subject is classified as having a moderate or severe (GOLD 2/3) airflow obstruction defined by a post-bronchodilator of ≥30% FEV1 to \<80% predicted with a baseline FEV1/FVC of \<0.70
• Subject has a Baseline SGRQ of ≥50
• Subject demonstrates daily cough and significant mucus.
• Subject is being treated according to current medically accepted treatment guidelines for chronic bronchitis for minimum of 3 months prior to enrollment into the study. Subject agrees to continue maintenance pulmonary/COPD medications (GOLD standard medications recommended) for the duration of the study
• Non-smoking for a minimum of 2 months prior to consent and agrees to continue not smoking for the duration of the study
• Subject is able to adhere to and undergo 2 bronchoscopic procedures (cross over subjects may undergo two additional bronchoscopic procedures, if they agree to treatment), per hospital guidelines
• Subject demonstrates ability and willingness to use a daily eDiary

You may not qualify if:

• Subject has had an acute pulmonary infection, exacerbation or pneumonia requiring medical treatment (with antibiotics and/or steroids) within 4 weeks prior of initially planned study bronchoscopy
• Current diagnosis of Asthma
• Subject has Alpha-1 antitrypsin deficiency as defined by blood level \<59 mg/dL
• Subject has other origins of respiratory disease aside from chronic bronchitis and COPD
• Subject is using e-cigarettes, vaping or taking any inhaled substances not prescribed by a physician
• Subject has untreatable or life threatening arrhythmias, inability to adequately oxygenate during the bronchoscopy, or has acute respiratory failure
• Subject has bullous emphysema characterized as large bullae \>30 millimeters on HRCT; or subject has stenosis in the tracheobronchial system, tracheobronchomegaly, trachea-bronchomalacia, amyloidosis or cystic fibrosis
• Subject has clinically significant bronchiectasis
• Subject has had a solid transplant procedure
• Subject has a known mucosal tear, has undergone prior lung surgery such as pneumonectomy, lobectomy, bullectomy, or lung volume reduction surgery
• Subject has had a prior lung device procedure, including emphysema stent(s) implanted, lung coils, valves, lung denervation, bronchial thermoplasty, cryotherapy or other therapies
• Subject is unable to temporarily discontinue use of anticoagulant therapy: warfarin, Coumadin, LMWH, heparin, clopidrogel (or equal)
• Subject has a serious medical condition, such as: uncontrolled coagulopathy or bleeding disorder, congestive heart failure, uncontrolled angina, myocardial infarction in the past year, renal failure, liver disease, cerebrovascular accident within the past 6 months, uncontrolled diabetes, uncontrolled hypertension or uncontrolled gastric reflux
• Subject is pregnant, nursing, or planning to get pregnant during study duration
• Subject has or is receiving chemotherapy or active radiation therapy within the past 6 months or is expected to receive chemotherapy during participation in this study

Sponsors & Collaborators

• CSA Medical, Inc.: lead

Study Sites (27)

Honor Health

Scottsdale, Arizona, 08258, United States

Location

El Camino Hospital

Mountain View, California, 94040, United States

Location

University of California, Davis Medical Center

Sacramento, California, 95817, United States

Location

Advanced Pulmonary Research Institute

Loxahatchee Groves, Florida, 33470, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Louisiana State University Medical Center

Shreveport, Louisiana, 71103, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins Universtiy

Baltimore, Maryland, 21287, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Cooper Health System

Camden, New Jersey, 08103, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

University Of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

The Ohio State Universisty

Columbus, Ohio, 43210, United States

Location

Clinical Research Associates of Central PA

Altoona, Pennsylvania, 16601, United States

Location

Temple University - Of the Commonwealth System of Higher Education

Philadelphia, Pennsylvania, 19140, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Prisma Health - Midlands

Columbia, South Carolina, 29203, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

St. David's Georgetown Hospital

Georgetown, Texas, 78626, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

The Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

MeSH Terms

Conditions

Bronchitis, Chronic

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gerard Criner, MD

  Temple University Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized, sham-controlled

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: March 28, 2019
• Study Start: July 9, 2020
• Primary Completion: May 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (26); GB (1)