Use of ARINA-1 in an Intermediate Size Patient Population of Bilateral Lung Transplant Patients With CLAD Grade 0

• Status: Completed
• Trial end date: 2019-06-25
• Target enrollment: 0
• Participant gender: All

Summary

To treat an intermediate size patient population of bilateral lung transplant patients with CLAD-0.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Treatments: Ascorbic Acid

Criteria

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