Use of ARINA-1 in an Intermediate Size Patient Population of Bilateral Lung Transplant Patients With CLAD Grade 0
Status: | Active, not recruiting |
---|---|
Conditions: | Hospital |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 21 - Any |
Updated: | 1/20/2019 |
Start Date: | December 11, 2017 |
End Date: | August 1, 2019 |
Use of ARINA-1 in an Intermediate Size Patient Population of Bilateral Lung Transplant Patients With CLAD Grade 0 at Duke University to Improve FEV1
To treat an intermediate size patient population of bilateral lung transplant patients with
CLAD-0.
CLAD-0.
To treat an intermediate size patient population of bilateral lung transplant patients with
CLAD-0. Treating physicians will follow standard of care for patients and monitor pulmonary
function, fractional exhaled nitric oxide and quality of life of the patients.
Patient safety will be monitored by assessing changes in these parameters, as well as changes
in standard of care measurements (e.g., laboratory values and x-ray images).
CLAD-0. Treating physicians will follow standard of care for patients and monitor pulmonary
function, fractional exhaled nitric oxide and quality of life of the patients.
Patient safety will be monitored by assessing changes in these parameters, as well as changes
in standard of care measurements (e.g., laboratory values and x-ray images).
Inclusion Criteria:
1. >6 months post-bilateral lung transplant
2. Any patient with a stable FEV1 or a decline that is < 20% from baseline.
3. No current signs of infection
4. No current signs of rejection
5. >21 years old
6. Routinely followed at the enrolling site
7. Capable of giving informed consent
Exclusion Criteria:
1. Interstitial or peribronchial/peribronchiolar fibrosis on transbronchial biopsy
2. Evidence of active congestive heart failure or symptomatic coronary artery disease, in
the opinion of the site investigator
3. CLAD grade 1 or higher
4. Currently on any ICS therapy
5. Initiation of chronic azithromycin within 1 month of study enrollment (chronic
azithromycin use defined as azithromycin 250mg or 500mg daily or every Monday,
Wednesday, Friday)
6. Positive pregnancy test at screening, if female and of child bearing potential
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