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

Study Overview
=================
Brief Summary
-----------------
To treat an intermediate size patient population of bilateral lung transplant patients with CLAD-0.

Detailed Description
-----------------
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).

Official Title
-----------------
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

Conditions
-----------------
Lung Transplant

Intervention / Treatment
-----------------
* Drug: Ascorbic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARINA-1<br>Ascorbic acid (ARINA-1) (inhaled ascorbic acid 88 mg/ml) will be nebulized twice daily for 3 months using a PARI eFlow nebulizer | Drug: Ascorbic Acid<br>* ARINA-1 (inhaled ascorbic acid 88 mg/ml) will be nebulized twice daily for 3 months using a PARI eFlow nebulizer<br>* Other names: ARINA-1;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in FEV1 | Each individual's changes in pulmonary function will be assessed using the linear slope of FEV1 change from enrollment to the end of the treatment period. | Baseline, 1 month, 3 months, 6 months, 12 months | 
| Changes in FENO | Each individual's changes in FENO will be assessed using the change in mean baseline FENO measurements to the mean measurements post-ARINA-1 use. | Baseline | 
| Changes in Quality of Life | Patient-reported quality of life measures assessed pre- and post-ARINA-1 will be compared for each participant. | Baseline, 12 months |