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

Completed · Phase 1

Conditions studied: Lung Transplant

In brief

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

Key facts

Study ID

NCT03226431

Run by

Duke University

People needed

6

Starts

2017-12-11

Expected to finish

2019-06-25

Last updated by the study team

2019-07-05

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• >6 months post-bilateral lung transplant
• Any patient with a stable FEV1 or a decline that is < 20% from baseline.
• No current signs of infection
• No current signs of rejection
• >21 years old
• Routinely followed at the enrolling site
• Capable of giving informed consent

You may not qualify if…

• Interstitial or peribronchial/peribronchiolar fibrosis on transbronchial biopsy
• Evidence of active congestive heart failure or symptomatic coronary artery disease, in the opinion of the site investigator
• CLAD grade 1 or higher
• Currently on any ICS therapy
• 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)
• Positive pregnancy test at screening, if female and of child bearing potential

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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