RejuvenAir® System Trial for COPD With Chronic Bronchitis (SPRAY-CB)

April 30, 2024 updated by: CSA Medical, Inc.

A Sham Controlled Prospective Randomized Clinical Trial of the RejuvenAir® System for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease With Chronic Bronchitis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The RejuvenAir® System is a cryosurgical device that applies medical-grade liquid nitrogen to the treatment area via a radial head catheter in a small, accurately directed spray. Cryotherapy with the RejuvenAir® System is designed to induce a regenerative endobronchial tissue effect by: 1) destroying via cryotherapy the abnormal surface epithelium that has become overgrown with mucin producing goblet cells, 2) thus allowing normal bronchial epithelium with a regrowth of ciliated epithelial cells that will facilitate the removal of mucins from the bronchial airways and 3) lead to a reduction in chronic inflammation and its accompanying mucosal swelling with resultant increase in the treated airway diameter. This reversal of inflamed epithelium may also lessen systemic inflammation.

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom, SW3 6NP
        • Recruiting
        • The Royal Brompton Hospital
        • Contact:
        • Principal Investigator:
          • Pallav Shah, MD
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 08258
        • Recruiting
        • Honor Health
        • Contact:
        • Principal Investigator:
          • Rick Sue, MD
    • California
      • Mountain View, California, United States, 94040
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California, Davis Medical Center
        • Contact:
        • Principal Investigator:
          • Ken Yoneda, MD
    • Florida
      • Loxahatchee Groves, Florida, United States, 33470
        • Recruiting
        • Advanced Pulmonary Research Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Neal Warshoff, D.O
      • Sarasota, Florida, United States, 34239
        • Recruiting
        • Sarasota Memorial Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joseph C. Seaman, MD
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Kentucky
      • Louisville, Kentucky, United States, 40218
        • Withdrawn
        • Norton Pulmonary Specialists
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • Louisiana State University Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Robert Holladay, MD
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland
        • Principal Investigator:
          • Ashutosh Sachdeva, MBBS
        • Contact:
      • Baltimore, Maryland, United States, 21287
        • Terminated
        • Johns Hopkins Universtiy
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Contact:
        • Principal Investigator:
          • Adnan Majiid, MD
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Terminated
        • Henry Ford Health System
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Spectrum Health
        • Principal Investigator:
          • Gustavo Cumbo-Nacheli, MD
        • Contact:
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth-Hitchcock Medical Center
        • Contact:
        • Principal Investigator:
          • David Feller-Kopman
    • New Jersey
      • Camden, New Jersey, United States, 08103
    • New York
      • New York, New York, United States, 10016
        • Withdrawn
        • New York University Langone Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kamran Mahmood, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • University of Cincinnati
        • Contact:
        • Principal Investigator:
          • Alejandro Aragaki, MD
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • The Cleveland Clinic Foundation
        • Principal Investigator:
          • Thomas Gildea, MD
        • Contact:
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State Universisty
        • Contact:
        • Principal Investigator:
          • Christian Ghattas, MD
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16601
        • Recruiting
        • Clinical Research Associates of Central PA
        • Principal Investigator:
          • Sandeep Bansal, MD
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • Temple University - Of the Commonwealth System of Higher Education
        • Principal Investigator:
          • Gerard Criner, MD
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19141
        • Withdrawn
        • Albert Einstein Healthcare Network
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Charlton Strange, MD
      • Columbia, South Carolina, United States, 29203
        • Active, not recruiting
        • Prisma Health - Midlands
    • Texas
      • Dallas, Texas, United States, 75390
      • Georgetown, Texas, United States, 78626
        • Recruiting
        • St. David's Georgetown Hospital
        • Contact:
        • Principal Investigator:
          • Dominic deKeratry, MD
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin Hospital and Clinics
        • Contact:
        • Principal Investigator:
          • J S Ferguson, MD
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
        • Principal Investigator:
          • Jonathan Kurman, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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
  • Subject is or has been in another treatment study within 6 weeks of enrollment and agrees to not participate in any other treatment studies for the duration of study participation
  • Subject has known sensitivity to medication required to perform bronchoscopy (such as lidocaine, atropine, and benzodiazepines)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment
RJA MCS
Device: RejuvenAir System
RejuvenAir Metered CryoSpray
Sham Comparator: Sham Control
Sham
Device: Sham Control Procedure
Sham Control Procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
St. George's Respiratory Questionnaire
Time Frame: 12 months
Change in St. George Respiratory Questionnaire (SGRQ) score from Baseline to 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjects experiencing serious adverse events (SAEs) rated as probably or definitely related to the study device or procedure
Time Frame: Within 30 days after either the first or second study procedure
Number of subjects experiencing one or more serious adverse events (SAEs) rated as probably or definitely related to the study device or procedure by the investigator within 30 days after either the first or second study procedure.
Within 30 days after either the first or second study procedure
Reduction of cough
Time Frame: Baseline through 12 months
Reduction of cough from Baseline through 12 months
Baseline through 12 months
Reduction of sputum
Time Frame: Baseline through 12 months
Reduction of sputum from Baseline through 12 months
Baseline through 12 months
Acute Exacerbation Rate (AECOPD)
Time Frame: 12 months
Acute Exacerbation rate (AECOPD, all severities) over 12 months
12 months
COPD assessment test (CAT) score
Time Frame: 12 months
COPD assessment test (CAT) from Baseline through 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CSA Medical, Inc.

Investigators

  • Principal Investigator: Gerard Criner, MD, Temple University Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2020

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

March 26, 2019

First Submitted That Met QC Criteria

March 26, 2019

First Posted (Actual)

March 28, 2019

Study Record Updates

Last Update Posted (Actual)

May 1, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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