For People with BOS & Family Page FAQ

Frequently Asked Questions (FAQ)

Breath Therapeutics, a Zambon company, is dedicated to developing innovative therapies by utilizing the true potential of inhaled drug delivery. People living with rare lung diseases are at the center of everything we do. Our novel drug-device combinations are designed to rapidly deliver high concentrations of drugs to the location in the lung where they are most needed.

Bronchiolitis obliterans syndrome (BOS), also known as obliterative bronchiolitis (OB), is a lung condition caused by inflammation that leads to scarring and blockage of the small airways. In many cases, this condition can result in respiratory failure and death. BOS is most commonly seen in people who have had a lung transplant or allogeneic hematopoietic stem cell transplant. BOS can also be associated with autoimmune diseases, lung infections, or exposure to environmental contaminants.

Currently, there are no approved treatments for BOS.  There is also no accepted or demonstrated standard-of-care for BOS.

Liposomal Cyclosporine A for Inhalation (L-CsA-i) is an investigational drug being studied to treat BOS.  Cyclosporine is a medicine that suppresses the immune system and reduces inflammation when taken by mouth or intravenously (IV).  Taking Cyclosporine by  mouth or by IV has many side effects to the rest of your body.  L-CsA-i is a new formulation of cyclosporine that enables it to become an aerosol when combined with the right aerosol delivery device.

Similar to taking other types of inhalers or nebulizers (aka puffers), the medication is being delivered directly to the location of the problem.

The Investigational eFlow®  Nebulizer System (PARI Pharma) will be used for inhalation.  L-CsA-i can only be used with the eFlow® Nebulizer System that is specifically made for its nebulization. For people enrolled to the treatment group of one of our clinical trials, these devices will be provided to administer the L-CsA-i. Proper education will be provided at the appropriate time for study patients in that group.

The company is currently conducting two global Phase 3 L-CsA-i trials for people with BOS following lung transplant.

If you are interested in learning more about a clinical trial, please go to clinicaltrials.gov as this is the easiest way to find a clinical research site near you.  You can contact the research team at the site, who will determine if you are a candidate for the study.

For more information on timelines and established centers, please see the links below.

BOSTON-1 (Single Lung Transplant) ClinicalTrials.gov Identifier: NCT03657342

BOSTON-2 (Double Lung Transplant) ClinicalTrials.gov Identifier: NCT03656926

Clinical trials are studies performed with people to examine new ways to prevent, detect, or treat disease. The purpose of clinical trials is to determine if a new medication or medical device works and if it is safe.  This is done before it is approved by the FDA (or equivalent) and made available for use by doctors.  With all clinical trials, there may be no direct benefit to any one individual who participates in a study.

The United States Food and Drug Administration (FDA) has a wealth of information on this subject.  Resources can be found via this link.

The company plans to offer BOSTON-3, an open-label extension trial, to people who have completed BOSTON-1 or BOSTON-2.  Please check back to our site for updates.

Currently, there is no compassionate use program for L-CsA-i.

L-CsA-i is being studied to see if it is a safe and effective treatment for people with BOS.

If you have additional questions, please contact patients@breath-therapeutics.com

Patient Resources:
Clinical Trials.gov

There are many disease foundations, patient advocacy groups, and support groups at both the local and national level.  Your transplant care team can direct you to resources that are in your area.