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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03226431

Acronym

ARINA-1

Enrollment

Registered

2017-07-21

Start date

2017-12-11

Completion date

2019-06-25

Last updated

2019-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Transplant

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).

Interventions

DRUGAscorbic Acid

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Changes in FEV1	Baseline, 1 month, 3 months, 6 months, 12 months	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.
Changes in FENO	Baseline	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.
Changes in Quality of Life	Baseline, 12 months	Patient-reported quality of life measures assessed pre- and post-ARINA-1 will be compared for each participant.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026