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)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Chronic Obstructive Pulmonary Disease, Unspecified
  • Age: Between 40 - 80 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Males and females =40 to <80 years of age
    2. Participants who are able to read, understand, and sign a written informed consent form in order to participate in the study
    3. Has a diagnosis of chronic bronchitis (CB) and chronic obstructive pulmonary disease (COPD) for a minimum of two years.
    4. Classified as having a moderate or severe (GOLD 2/3) airflow obstruction
    5. Has had either 2 moderate exacerbations or 1 severe exacerbation in the past year
    6. Demonstrates daily cough and significant mucus production
    7. Being treated according to current medically accepted treatment guidelines for CB
    8. Smoking history of at least 10 pack years
    9. Non-smoking for a minimum of 2 months prior to consent and agrees to continue not smoking for the duration of the study
    10. Able to adhere to and undergo 2 bronchoscopic procedures
    11. Demonstrates ability and willingness to use a daily eDiary

You may not be eligible for this study if the following are true:

    1. Has an acute pulmonary infection, exacerbation or pneumonia requiring medical treatment
    2. Diagnosis of Asthma
    3. Has Alpha-1 antitrypsin deficiency
    4. Other origins of respiratory disease aside from CB and COPD
    5. Using e-cigarettes, vaping or inhaled substances not prescribed by a physician
    6. Untreatable or life-threatening arrhythmias, inability to adequately oxygenate during the bronchoscopy, or has acute respiratory failure
    7. Bullous emphysema characterized as large bullae >30 millimeters
    8. Clinically significant bronchiectasis
    9. Has had a transplant procedure
    10. Has a known mucosal tear, has undergone prior lung surgery such as pneumonectomy, lobectomy, bullectomy, or lung volume reduction surgery
    11. Has had a prior lung device procedure
    12. Unable to temporarily discontinue use of anticoagulant therapy: warfarin, Coumadin, LMWH, heparin, clopidrogel (or equal)
    13. Has a serious medical condition
    14. Pregnant, nursing or planning to get pregnant during study duration
    15. Has or is receiving chemotherapy or active radiation therapy within the past 6 months
    16. Is or has been in another clinical investigational study within 6 weeks
    17. Has known sensitivity to medication required to perform bronchoscopy (such as lidocaine, atropine, and benzodiazepines)



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