CSA (Chronic Bronchitis) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out what effects (good or bad) the study device (RejuvenAir) may have on people with chronic bronchitis.

This device uses a cryospray (liquid nitrogen) that will go directly into the airways for the treatment of chronic bronchitis.

What is the Condition Being Studied?

Chronic Bronchitis

Who Can Participate in the Study?

-Men and Women, age 40-80
-Have had chronic bronchitis for 2 years or more
-Have previously smoked, but not currently
-Do not have asthma
-Have been treated for breathing problems in the past year

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
-Have a physical exam to make sure it is safe for you to join
-Be randomized (2 out of 3 will be in Group 1) to Group 1 or Group 2
---Group 1 will get the study cryospray during a bronchoscopy
---Group 2 will have a mock bronchoscopy that will not have the cryospray

Both groups will:
-Have 2 bronchoscopies, 30 – 60 days apart
-Fill out a daily diary about your breathing symptoms and quality of life

* If you were in the mock cyrospray group we will give you the opportunity to receive the cryospray after the study.

Study Details

Full 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 (SPRAY-CB)
Principal Investigator
Protocol Number
IRB: PRO00102593
NCT: NCT03893370
Phase
Phase N/A
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698