NEWSLETTER NO. 5

The BOSTON 1&2 Studies Newsletter goes Digital!

With this edition of the newsletter, we are exploring a new “digital” format. We hope this will improve the accessibility of the newsletter either from a smartphone or a regular computer. Our idea is also to provide more frequent updates than previously. If you want to share feedback on the newsletter, this is very welcome!

Study Restart in Fall!

Due to the challenges from the COVID-19 outbreak this year, the Sponsor determined to halt recruitment into the studies in March. Since then, we have been exploring all possibilities for ensuring data validity and safety of patients already in the study or of those recruited after study restart also in line with Health Authorities recommendations. Since then, we have been exploring all possibilities for ensuring data validity and safety of patients already in the study or of those recruited after study restart in line with Health Authorities recommendations. Although the pandemic is not over yet, most countries and health care systems have successfully adopted strategies on managing healthcare and research in the environment of a pandemic. For patients undergoing lung transplants and being monitored for the development of BOS, the current situation is especially challenging.

We are therefore confident that adopting specific measures, recruitment can re-start and we are planning to do so after the summer and upon approval by the regulatory authorities, which is a requirement. Since recruitment has been on hold for more than six months, we are planning a series of events to ensure a smooth study restart by reviewing study procedures, hurdles and opportunities based on the experience gathered so far.

To this end, around the end of September, you will be invited to investigator meetings at which we will update the site teams on the next steps and new study procedures. These meetings are planned per region in a virtual setting. The meetings will be followed by “technical” training on study procedures per site according to the individual site’s needs, also in a virtual format. Where needed or helpful, re-initiation visits at sites will be performed. Covance will inform and update you on details.

Study Protocol Amendments

We did make use of the COVID-19 break to improve the BOSTON 1&2 study protocols in two aspects. We consulted with some sites on this, which was very helpful and much appreciated! The most relevant updates include:

Inclusion criteria: The requirement of a FEV1/FVC ratio of < 0.7 as marker of obstructive lung disease has been a major obstacle for patient recruitment. Therefore, this requirement has been removed as a criteria for patient inclusion. In order to preserve the patient population of patients with CLAD-BOS phenotype, a clinical diagnosis based on current ISHLT recommendations is required. Patients with restrictive lung disease of the CLAD-RAS phenotype are excluded. Home spirometry: All future patients will be equipped with portable spirometers. In the case, where site visits are not possible due to COVID-19 related limitations, this will allow for remote study visits. Details will be provided during the investigator meetings and specific training sessions.

Other minor amendments have also been included. The amended study protocol has been submitted for approvals by the regulatory authorities and IRBs/ECs. More detailed information on the study protocol amendments will be shared during the upcoming investigator meetings.

NEW: Clinical Support & Services

In order to be more involved in addressing opportunities or hurdles on the study conduct at the individual sites, with more resources now available, Breath Therapeutics and Zambon have created a “Clinical Support and Services Team”. This team will be dedicated to interacting with sites and providing direct access to the study sponsor. Clinical device trainers will provide hands-on training on the study device (eFlow), as well as on the portable home spirometers. In addition, there will be two clinical experts functioning as “site liaisons” that will provide sites with direct contact to the study sponsor. Clinical Support and Services will work in close cooperation with Covance. An introduction to the names and faces, as well as to roles, responsibilities and processes, will be provided in the next edition of the newsletter.

How Do You Like the Newsletters?

Feedback (positive or constructive) is welcome at boston.sitesupport@zambongroup.com.

Help Needed, Questions or Suggestions?

The development program for inhaled L-CsA for the treatment of bronchiolitis obliterans is very important to Zambon.

LabCorp is responsible for the operational conduct of the studies and your LabCorp contact should be your first point of contact for questions.

However, please do not hesitate to get in touch with us directly if you’d like. Emails addressed to boston.sitesupport@zambongroup.com will reach the Zambon study team and will be answered promptly.

Newsletters are for BOSTON clinical site personnel only and not intended to be shared with patients, trial participants or any external audiences.