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

Duke University

Status and phase: Completed; Phase 1

Conditions: Lung Transplant

Treatments: Drug: Ascorbic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT03226431

Pro00080819

Details and patient eligibility

About

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

Full 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).

Enrollment: 6 patients

Sex: All

Ages: 21+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

ARINA-1

Experimental group

Description:

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

Treatment:

Drug: Ascorbic Acid