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

Lung Transplant Clinical Trial

— ARINA-1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03226431
• Other study ID #: Pro00080819
• Status: Completed
• Phase: Phase 1
• Start date: December 11, 2017
• Est. completion date: June 25, 2019

Study information

• Verified date: September 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 25, 2019
• Est. primary completion date: June 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Transplant

Intervention

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

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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