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.
This device uses a cryospray (liquid nitrogen) that will go directly into the airways for the treatment of chronic bronchitis.
Who Can Participate?
Eligibility
-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
-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 Range
40-80
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
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.
-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.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
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
Kamran
Mahmood
Protocol Number
PRO00102593
NCT ID
NCT03893370
Phase
N/A
Enrollment Status
OPEN TO ACCRUAL