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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 : June 14, 2022
Sponsor:
Information provided by (Responsible Party):
CSA Medical, Inc.

Study Description
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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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 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


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. St. George's Respiratory Questionnaire [ Time Frame: 12 months ]
    Change in St. George Respiratory Questionnaire (SGRQ) score from Baseline to 12 months


Secondary Outcome Measures :
  1. 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.

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

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

  4. Acute Exacerbation Rate (AECOPD) [ Time Frame: 12 months ]
    Acute Exacerbation rate (AECOPD, all severities) over 12 months

  5. COPD assessment test (CAT) score [ Time Frame: 12 months ]
    COPD assessment test (CAT) from Baseline through 12 months


Eligibility Criteria
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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/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)
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): NCT03893370


Contacts
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Contact: Fran Avery, BS 781-538-4735 fkuhnen@csamedical.com
Contact: Heather Nigro, MS 781-538-4793 hnigro@csamedical.com

Locations
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Sponsors and Collaborators
CSA Medical, Inc.
Investigators
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Principal Investigator: Gerard Criner, MD Temple University Health System
More Information
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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: June 14, 2022
Last Verified: June 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
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