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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-11

Study Completion Date

2019-06-25

Brief Summary

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

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Detailed Description

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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).

Conditions

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Lung Transplant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ARINA-1

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

Group Type EXPERIMENTAL

Ascorbic Acid

Intervention Type DRUG

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

Interventions

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Ascorbic Acid

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

Intervention Type DRUG

Other Intervention Names

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ARINA-1

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No