What side effects are associated with this type of intervention?

Common treatments for Bronchiolitis Obliterans Syndrome (BOS) with anti-inflammatory or immunomodulatory effects, such as corticosteroids and immunosuppressive agents, can have several side effects. Corticosteroids may cause weight gain, hypertension, diabetes, osteoporosis, and increased risk of infections. Immunosuppressive agents, like tacrolimus or cyclophosphamide, can lead to nephrotoxicity, hepatotoxicity, increased susceptibility to infections, and potential malignancies. These side effects necessitate careful monitoring and management by healthcare providers.

What prior FDA approvals exist?

There are limited FDA-approved treatments specifically for Bronchiolitis Obliterans Syndrome (BOS). However, treatments with anti-inflammatory or immunomodulatory effects, such as corticosteroids and immunosuppressive agents, are commonly used to manage the condition. These treatments aim to reduce inflammation and prevent further lung damage, thereby improving quality of life. The trial of ARINA-1, which likely has similar anti-inflammatory or immunomodulatory effects, represents an ongoing effort to find more effective therapies for BOS.

What other types of research exist?

Promising alternatives to ARINA-1 for Bronchiolitis Obliterans Syndrome patients include nintedanib and pirfenidone, both of which have antifibrotic properties and are used in the treatment of idiopathic pulmonary fibrosis. Additionally, biologic agents such as abatacept and kinase inhibitors used in rheumatic diseases may also be considered for their immunomodulatory effects.

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Immunomodulator

ARINA-1 for Bronchiolitis Obliterans Syndrome

Phase 3

Recruiting

Led By Ramsey Hachem, MD

Research Sponsored by Renovion, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-75 years old at the time of consent

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 weeks

Awards & highlights

Study Summary

This trial compares the effectiveness of a new drug to the existing standard of care for lung transplant recipients to see if it can improve quality of life and prevent or delay the need for additional treatment.

Who is the study for?

This trial is for adults aged 18-75 who've had a bilateral lung transplant over a year ago and are experiencing a decline in lung function. They must be on stable medications, including azithromycin and immunosuppressants, willing to follow the study schedule, and women of childbearing age must use birth control. Exclusions include recent use of certain therapies or supplements, unresolved lung damage, severe heart or kidney disease, participation in other trials recently, and specific treatments within set timeframes.Check my eligibility

What is being tested?

The trial tests ARINA-1 combined with standard care against standard care alone to see if it can prevent worsening of bronchiolitis obliterans syndrome (BOS) after lung transplants. It also looks at whether ARINA-1 helps maintain quality of life by reducing the need for increased immunosuppression therapy.See study design

What are the potential side effects?

While not explicitly listed here, side effects may include typical reactions related to new medications such as gastrointestinal issues, allergic reactions or skin rashes. Participants will have regular clinic visits and phone calls to monitor any adverse events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage change from baseline in FEV1 (%ΔFEV1)

Secondary outcome measures

Change from baseline in Saint George's Respiratory Questionnaire total score

Number of participants in each arm with augmented immunosuppression

Percentage change from baseline of FEF25-75%

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard of care onlyExperimental Treatment1 Intervention

Standard 3-therapy immunosuppression regimen and azithromycin

Group II: ARINA-1 plus standard of careExperimental Treatment1 Intervention

ARINA-1 (88 mg/mL ascorbic acid, ASC; 150 mg/mL reduced glutathione, GSH); fixed dose, 4 mL solution inhaled twice daily via nebulization plus standard 3-therapy immunosuppression regimen and azithromycin

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ARINA-1

2022

Completed Phase 2

~40

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Bronchiolitis Obliterans Syndrome (BOS) include corticosteroids, immunosuppressive agents, and other anti-inflammatory medications. These treatments work by reducing inflammation and modulating the immune response, which are critical in preventing the progression of BOS. Corticosteroids help to decrease the inflammatory response in the airways, while immunosuppressive agents like tacrolimus and azathioprine inhibit the immune system's activity to prevent further damage to lung tissue. These mechanisms are essential for BOS patients as they help to preserve lung function, reduce symptoms, and improve overall quality of life.