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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 (SPRAY-CB)

Study Type/Phase: Interventional
Enrollment Status: Recruiting

Chronic Obstructive Pulmonary Disease (COPD) is defined as an impaired ability to move air within the lungs and is a major public health problem with an unmet medical need. Chronic Bronchitis (CB) is defined as chronic cough and sputum production for 3 months a year for 2 consecutive years. CB is associated with many consequences, including; the worsening of lung function, increasing risk of acute exacerbations of COPD, increased risk of developing pneumonia, and reduced health-related quality of life.

The RejuvenAir System is a new device developed as a treatment option for CB. This study uses the RejuvenAir™ System, which delivers liquid nitrogen through a catheter to instantly flash freeze the lining of the airways (also called metered spray cryotherapy). Liquid Nitrogen has been used for over 50 years to treat other medical conditions that require regeneration of unhealthy tissue, such as when a doctor sprays a patient's skin with liquid nitrogen to get rid of unhealthy tissue. However, the use of liquid nitrogen in this study, to treat symptomatic chronic bronchitis, is a new use of this freezing agent.

This is a randomized study to evaluate the safety and effectiveness of the RejuvenAir System developed for patients with chronic bronchitis. This device has not been approved by the U.S. Food and Drug Administration (FDA).

330 subjects will take part in this study at 30 sites in the United States, Canada, and Europe. Approximately 20 subjects will take part in this study at Mountain View Hospital (El Camino Hospital).

Speak with your doctor to determine whether you meet the following criteria for participation in this study.

Inclusion Criteria Exclusion Criteria
  • Males and females ≥40 to <80 years of age
  • Subject has a diagnosis of chronic bronchitis (CB) and chronic obstructive pulmonary disease (COPD) for a minimum of two years
  • Subject is classified as having a moderate or severe airflow obstruction defined by a post-bronchodilator
  • Subject has had either 2 moderate exacerbations or 1 severe exacerbation in the past year
  • 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 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
  • Subject has had an acute pulmonary infection, exacerbation or pneumonia requiring treatment 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 oral or 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 High Resolution Computed Tomography (HRCT); or subject has stenosis in the tracheobronchial system, tracheobronchomegaly, trachea bronchomalacia, amyloidosis or cystic fibrosis
  • Subject has clinically significant bronchiectasis
  • Subject has had any transplant procedure
  • Subject has a known mucosal tear or has undergone prior lung surgery
  • Subject has had a prior lung device procedure
  • Subject is unable to temporarily discontinue use of anticoagulant therapy
  • 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

Principal Investigator

Ganesh Krishna, MD

Sponsor

CSA Medical, Inc.

NCT Number

NCT03893370

For more information about this clinical trial, including trial status, eligibility and full trial listing, visit www.clinicaltrials.gov.

 

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