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

Duke University6 enrolled

Overview

To treat an intermediate size patient population of bilateral lung transplant patients with 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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Transplant

Interventions

Ascorbic AcidDRUG

ARINA-1 (inhaled ascorbic acid 88 mg/ml) will be nebulized twice daily for 3 months using a PARI eFlow nebulizer

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Baseline

Changes in Quality of Life

Patient-reported quality of life measures assessed pre- and post-ARINA-1 will be compared for each participant.

Time frame: Baseline, 12 months

Data from ClinicalTrials.gov

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