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:
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Conditions: Chronic Obstructive Pulmonary Disease, Unspecified
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Age: Between 40 years - 80 years
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Gender: Male or Female
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Other Inclusion Criteria:
- Males and females =40 to <80 years of age
- Participants who are able to read, understand, and sign a written informed consent form in order to participate in the study
- Has a diagnosis of chronic bronchitis (CB) and chronic obstructive pulmonary disease (COPD) for a minimum of two years.
- Classified as having a moderate or severe (GOLD 2/3) airflow obstruction
- Has had either 2 moderate exacerbations or 1 severe exacerbation in the past year
- Demonstrates daily cough and significant mucus production
- Being treated according to current medically accepted treatment guidelines for CB
- 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
- Able to adhere to and undergo 2 bronchoscopic procedures
- Demonstrates ability and willingness to use a daily eDiary
You may not be eligible for this study if the following are true:
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- Has an acute pulmonary infection, exacerbation or pneumonia requiring medical treatment
- Diagnosis of Asthma
- Has Alpha-1 antitrypsin deficiency
- Other origins of respiratory disease aside from CB and COPD
- Using e-cigarettes, vaping or inhaled substances not prescribed by a physician
- Untreatable or life-threatening arrhythmias, inability to adequately oxygenate during the bronchoscopy, or has acute respiratory failure
- Bullous emphysema characterized as large bullae >30 millimeters
- Clinically significant bronchiectasis
- Has had a transplant procedure
- Has a known mucosal tear, has undergone prior lung surgery such as pneumonectomy, lobectomy, bullectomy, or lung volume reduction surgery
- Has had a prior lung device procedure
- Unable to temporarily discontinue use of anticoagulant therapy: warfarin, Coumadin, LMWH, heparin, clopidrogel (or equal)
- Has a serious medical condition
- Pregnant, nursing or planning to get pregnant during study duration
- Has or is receiving chemotherapy or active radiation therapy within the past 6 months
- Is or has been in another clinical investigational study within 6 weeks
- Has known sensitivity to medication required to perform bronchoscopy (such as lidocaine, atropine, and benzodiazepines)
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.