Lung TransplantPhase 1ARINA-1NCT03226431
Use of ARINA-1 in an Intermediate Size Patient Population of Bilateral Lung Transplant Patients With CLAD Grade 0
A Phase 1 study testing Ascorbic Acid in people with Lung Transplant, run by Duke University at 1 site in United States.
Trial summary
To treat an intermediate size patient population of bilateral lung transplant patients with CLAD-0. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Lung Transplant
- What is being tested?
- Ascorbic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2017to 25 Jun 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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
To treat an intermediate size patient population of bilateral lung transplant patients with CLAD-0.
Read the 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).
- Conditions
- Lung Transplant
- Being tested
- Ascorbic Acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic AcidDrug
Also called ARINA-1
ARINA-1 (inhaled ascorbic acid 88 mg/ml) will be nebulized twice daily for 3 months using a PARI eFlow nebulizer
| Study group | Role | What they receive |
|---|---|---|
| ARINA-1 | Experimental | Ascorbic acid (ARINA-1) (inhaled ascorbic acid 88 mg/ml) will be nebulized twice daily for 3 months using a PARI eFlow nebulizer Receives: Drug: Ascorbic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Changes in Quality of Life
Patient-reported quality of life measures assessed pre- and post-ARINA-1 will be compared for each participant.
Measured: Baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start11 Dec 2017
- Primary completion25 Jun 2019
- Study completion25 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Omar Mohamedaly, MD, Principal investigator, Duke HealthLorenzo Zaffiri, MD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226431
- Sponsor's protocol ID
- Pro00080819
- Acronym
- ARINA-1
- Status last verified
- Sep 2018
- First submitted
- 14 Jul 2017
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03226431
- Acronym / sponsor ID
- ARINA-1 / Pro00080819
- Conditions
- Lung Transplant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 25 Jun 2019 (actual)
- Study completion
- 25 Jun 2019 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARINA-1 | Experimental | Drug: Ascorbic AcidAscorbic acid (ARINA-1) (inhaled ascorbic acid 88 mg/ml) will be nebulized twice daily for 3 months using a PARI eFlow nebulizer |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- >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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ascorbic AcidAlso: ARINA-1ARINA-1 (inhaled ascorbic acid 88 mg/ml) will be nebulized twice daily for 3 months using a PARI eFlow nebulizer | Drug | ARINA-1 |
Primary outcome
Changes in FEV1
Time frame: 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
Time frame: 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
Time frame: Baseline, 12 months
Patient-reported quality of life measures assessed pre- and post-ARINA-1 will be compared for each participant.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omar Mohamedaly, MD principal investigator
Duke Health
Lorenzo Zaffiri, MD principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ascorbic Acid in people with Lung Transplant, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in FEV1 (time frame: Baseline, 1 month, 3 months, 6 months, 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.