BridgeMD
Prevention study for Pre-Bronchiolitis Obliterans Syndrome
Official title Study to Evaluate ARINA-1 in the Prevention of Bronchiolitis Obliterans Progression in Participants With Bilateral Lung Transplant
ClinicalTrials.gov ID: NCT05654922
What this study is testing
What is ARINA-1?
ARINA-1 is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for pre-bronchiolitis obliterans syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this Phase 3 clinical trial is to compare ARINA-1 (a nebulized immunomodulatory agent) plus Standard of Care vs Standard of Care alone. The main question it aims to answer are: Evaluate the effectiveness of ARINA-1 in preventing bronchiolitis obliterans syndrome (BOS) progression in participants with a bilateral lung transplant To evaluate the effectiveness of ARINA-1 on improving quality of life decline and preventing or delaying the use of augmented immunosuppression in participants with pre-BOS relative to SOC.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Bilateral lung transplant \>12 months from the time of Visit 1 / Randomization
- Age 18-75 years old at the time of consent
- Routinely followed at enrolling site
- Willing and able to comply with visit schedule and at-home requirements
- 10-24% decrease in FEV1 from the post-transplant baseline within the last 12 months.
You likely can't join if
- Positive urine pregnancy test at screening and baseline visit
- Diagnosis of active congestive heart failure or symptomatic coronary artery disease \> grade 3 based on the New York Heart Association Functional...
- Restrictive allograft syndrome (RAS) defined by radiographic interstitial or alveolar opacities on chest X-ray or CT scan that are consistent with RAS
- Have advanced BOS, defined by \>24% decrease in FEV1 in post-transplant baseline
- A diagnosis of probable antibody-mediated rejection (AMR) \<12 months prior to the baseline visit
- Donor-specific antibodies (DSA) identified \ 6 months from the baseline visit is acceptable for enrollment into the study.
See the full eligibility criteria
- Bilateral lung transplant \>12 months from the time of Visit 1 / Randomization
- Age 18-75 years old at the time of consent
- Routinely followed at enrolling site
- Willing and able to comply with visit schedule and at-home requirements
- 10-24% decrease in FEV1 from the post-transplant baseline within the last 12 months.
- Capable of giving informed consent
- On a stable maintenance regimen of azithromycin for \>4 weeks prior to the Screening Visit
- On a stable 2-agent or 3-agent immunosuppression regimen that includes a steroid, a calcineurin inhibitor (CNI), and, optionally, a cell cycle inhibitor (e.g., mycophenolate, azathioprine) \>4 weeks prior to Screening
- If a woman of childbearing potential (WOCBP), must agree to use a reliable method of birth control for the entire duration of the study.
- Positive urine pregnancy test at screening and baseline visit
- Diagnosis of active congestive heart failure or symptomatic coronary artery disease \> grade 3 based on the New York Heart Association Functional Classification (NYHA) criteria
- Restrictive allograft syndrome (RAS) defined by radiographic interstitial or alveolar opacities on chest X-ray or CT scan that are consistent with RAS
- Have advanced BOS, defined by \>24% decrease in FEV1 in post-transplant baseline
- A diagnosis of probable antibody-mediated rejection (AMR) \<12 months prior to the baseline visit
- Donor-specific antibodies (DSA) identified \ 6 months from the baseline visit is acceptable for enrollment into the study.
- Unresolved diffuse alveolar damage
- Receiving mechanical ventilation
- Chronic kidney disease stage IV or higher, including on dialysis
- Initiating a new maintenance therapy or changing immunosuppression maintenance therapy (e.g., changing tacrolimus to cyclosporine) \<30 days prior to the baseline visit.
- Have initiated or changed mTOR maintenance therapy \ 3 months is allowed)
- Initiating or changing antibiotic (including azithromycin), antiviral, or antifungal therapy \<14 days prior to the baseline visit.
- Use of alemtuzumab \<6 months prior to the baseline visit
- Use of anti-thymocyte therapies (e.g., anti-thymocyte globulin) or photopheresis \ 90 days prior to the Screening Visit.
- Initiating a multivitamin or other supplement (inhaled, oral, or IV) containing vitamin C, glutathione, or N-acetylcysteine \<90 days prior to the baseline visit
- Significant unstable comorbidities, in the opinion of the site investigator
- Allery or previous adverse reaction to azithromycin
- A diagnosis of dynamic collapse / tracheobrochomalacia \<90 days of the baseline visit.
- people currently participating in, or who have participated in an treatment (drug or device) clinical study \<30 days of the baseline visit.
- Have been diagnosed with ARAD within 6 weeks of the Screening Visit.
- Have used belatacept \<6 months prior to Clinic Visit 1
- Have had an initial treatment of bronchial stents or cryotherapy within 12 months of the Screening Visit, or had bronchial stents removed within the last 3 months of the Screening Visit.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- San Diego, California, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Maywood, Illinois, United States
- Iowa City, Iowa, United States
- Baltimore, Maryland, United States
- Minneapolis, Minnesota, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Charleston, South Carolina, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Falls Church, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Los Angeles, California, United States; San Diego, California, United States; Orlando, Florida, United States; Tampa, Florida, United States; Maywood, Illinois, United States and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.