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Trial record 1 of 1 for:    NCT03893370
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RejuvenAir® System Trial for COPD With Chronic Bronchitis (SPRAY-CB)

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ClinicalTrials.gov Identifier: NCT03893370
Recruitment Status : Recruiting
First Posted : March 28, 2019
Last Update Posted : September 21, 2020
Sponsor:
Information provided by (Responsible Party):
CSA Medical, Inc.

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.

Condition or disease Intervention/treatment Phase
Chronic Bronchitis Device: RejuvenAir System Device: Sham Control Procedure Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: randomized, sham-controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 9, 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Acute Exacerbation Rate (AECOPD) [ Time Frame: 12 months ]
    Acute Exacerbation rate (AECOPD, all severities) over 12 months

  2. St. George's Respiratory Questionnaire [ Time Frame: 12 months ]
    Change in St. George Respiratory Questionnaire (SGRQ) score from Treatment 1 to 12 months


Secondary Outcome Measures :
  1. 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. [ 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.

  2. Reduction of cough [ Time Frame: Treatment 1 through 12 months ]
    Reduction of cough from Treatment 1 through 12 months

  3. Reduction of sputum [ Time Frame: Treatment 1 through 12 months ]
    Reduction of sputum from Treatment 1 through 12 months

  4. Rate and time to first mild/moderate/severe/very severe AECOPD [ Time Frame: 12 months ]
    Rate and time to first mild/moderate/severe/very severe AECOPD exacerbation at 12 months

  5. Time to next AECOPD exacerbation (mild/moderate/severe/very severe) [ Time Frame: 12 months ]
    Time to next AECOPD exacerbation (mild/moderate/severe/very severe)



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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 has had either 2 moderate exacerbations or 1 severe exacerbation in the past year. (exacerbations must be documented)
  • 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
  • Smoking history of at least 10 pack years
  • 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
  • Diagnosis of Asthma
  • Subject has Alpha-1 antitrypsin deficiency
  • 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 transplant procedure (any)
  • 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, autoimmune disease 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 clinical investigational 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)

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): NCT03893370


Contacts
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Contact: Fran Avery, BS 781-538-4735 fkuhnen@csamedical.com
Contact: Joyce Musacchio, BS 781-538-4794 jmusacchio@csamedical.com

Locations
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United States, California
El Camino Hospital Recruiting
Mountain View, California, United States, 94040
Contact: Karen Ng    650-962-4563    Karen_Ng@elcaminohospital.org   
Contact: Janet Lamm    650-962-4466    Janet_Lamm@elcaminohealth.org   
Principal Investigator: Ganesh Krishna, MD         
University of California, Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Tina Tham    916-734-3351    ttham@ucdavis.edu   
Principal Investigator: Ken Yoneda, MD         
United States, Florida
Sarasota Memorial Hospital Not yet recruiting
Sarasota, Florida, United States, 34239
Contact: Kristen Boyd, ACRP-CP    941-917-7109    Kristen-Boyd@smh.com   
Contact: Tamela Fonseca, MSN, RN    941-917-2475    Tamela-Fonseca@smh.com   
Principal Investigator: Joseph C. Seaman, MD         
United States, Kentucky
Norton Pulmonary Specialists Not yet recruiting
Louisville, Kentucky, United States, 40218
Contact: Kelly O'Neill Richey, RN, BSN    502-479-1217 ext 146    Kelly.ONeillRichey@nortonhealthcare.org   
Contact: Nancy McDonald, RN, BSN    502-479-1217 ext 134    nancy.mcdonald@nortonhealthcare.org   
Principal Investigator: Tanya Wiese, DO         
United States, Louisiana
Louisiana State University Medical Center Not yet recruiting
Shreveport, Louisiana, United States, 71103
Contact: Teresa Harris, RN    318-429-2160 ext 213    tharr3@lsuhsc.edu   
Contact: Misty Prince    318-429-2157 ext 214    mprinc@lsuhsc.edu   
Principal Investigator: Robert Holladay, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Erick Flores       eflores2@bidmc.harvard.edu   
Principal Investigator: Adnan Majiid, MD         
United States, Michigan
Henry Ford Health System Not yet recruiting
Detroit, Michigan, United States, 48202
Contact: Jackie Day, RN, BSN    313-916-1254    jday5@hfhs.org   
Principal Investigator: Michael Simoff, MD         
United States, New York
New York University Langone Medical Center Recruiting
New York, New York, United States, 10016
Contact: Ashley Witzl    212-263-1208    Ashley.Witzl@nyulangone.org   
Principal Investigator: Samaan Rafeq, MD         
United States, North Carolina
Duke University Not yet recruiting
Durham, North Carolina, United States, 27705
Contact: Kathleen Coles    919-668-3812    kathleen.coles@duke.edu   
Contact: Jessica Shier    919-684-9139    Jessica.shier@duke.edu   
Principal Investigator: Momen Wahidi, MD         
United States, Ohio
The Ohio State Universisty Not yet recruiting
Columbus, Ohio, United States, 43210
Contact: Jamaal Saleh, BS    614-366-2258    jamaal.saleh@osumc.edu   
Principal Investigator: Christian Ghattas, MD         
United States, Pennsylvania
Temple University - Of the Commonwealth System of Higher Education Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: CR Department    215-707-1359    breathe@temple.edu   
Principal Investigator: Gerard Criner, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Gwen Blanton    843-792-8438    blantonm@musc.edu   
Principal Investigator: Charlton Strange, MD         
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Adetoun Sodimu    214-645-6493    adetoun.sodimu@UTSouthwestern.edu   
Contact: Daisy Gonzalez    214-645-1372    daisy.gonzalez@UTSouthwestern.edu   
Principal Investigator: Muhanned Abu-Hijleh, MD         
United States, Wisconsin
University of Wisconsin Hospital and Clinics Not yet recruiting
Madison, Wisconsin, United States, 53792
Contact: Matt Giles, BS, CCRC    608-265-8057    mpgiles@clinicaltrials.wisc.edu   
Principal Investigator: J S Ferguson, MD         
Sponsors and Collaborators
CSA Medical, Inc.
Investigators
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Principal Investigator: Gerard Criner, MD Temple University Health System
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Responsible Party: CSA Medical, Inc.
ClinicalTrials.gov Identifier: NCT03893370    
Other Study ID Numbers: 016
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020
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
Additional relevant MeSH terms:
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Bronchitis
Bronchitis, Chronic
Acute Disease
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Pulmonary Disease, Chronic Obstructive