Use of ARINA-1 in an Intermediate Size Patient Population of Bilateral Lung Transplant Patients With CLAD Grade 0
ARINA-1
1 other identifier
interventional
6
1 country
1
Brief Summary
To treat an intermediate size patient population of bilateral lung transplant patients with CLAD-0.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2017
CompletedFirst Posted
Study publicly available on registry
July 21, 2017
CompletedStudy Start
First participant enrolled
December 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 25, 2019
CompletedJuly 5, 2019
September 1, 2018
1.5 years
July 14, 2017
July 3, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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
Study Arms (1)
ARINA-1
EXPERIMENTALAscorbic acid (ARINA-1) (inhaled ascorbic acid 88 mg/ml) will be nebulized twice daily for 3 months using a PARI eFlow nebulizer
Interventions
ARINA-1 (inhaled ascorbic acid 88 mg/ml) will be nebulized twice daily for 3 months using a PARI eFlow nebulizer
Eligibility Criteria
You may qualify if:
- \>6 months post-bilateral lung transplant
- Any patient with a stable FEV1 or a decline that is \< 20% from baseline.
- No current signs of infection
- No current signs of rejection
- \>21 years old
- Routinely followed at the enrolling site
- Capable of giving informed consent
You may not qualify if:
- Interstitial or peribronchial/peribronchiolar fibrosis on transbronchial biopsy
- Evidence of active congestive heart failure or symptomatic coronary artery disease, in the opinion of the site investigator
- CLAD grade 1 or higher
- Currently on any ICS therapy
- 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)
- Positive pregnancy test at screening, if female and of child bearing potential
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (1)
Duke University Medical Center
Durham, North Carolina, 27710, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Omar Mohamedaly, MD
Duke Health
- PRINCIPAL INVESTIGATOR
Lorenzo Zaffiri, MD
Duke Health
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2017
First Posted
July 21, 2017
Study Start
December 11, 2017
Primary Completion
June 25, 2019
Study Completion
June 25, 2019
Last Updated
July 5, 2019
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share