BOSTON-3
Research type
Research Study
Full title
An Open Label Follow-Up Study to Evaluate the Long Term Safety and Efficacy of L-CSA in Patients with a Diagnosis of CLAD-BOS after they have completed the participation to BOSTON 1 and BOSTON 2 studies
IRAS ID
273873
Contact name
Jasvir Parmar
Contact email
Sponsor organisation
Zambon SpA
Eudract number
2019-002987-29
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 2 months, days
Research summary
This study, known as the BOSTON-3, study is designed to obtain information on the long-term safety and the effectiveness of an investigational product called aerolized Liposomal Cyclosporine A (L-CsA) when it is given to patients to treat Bronchiolitis Obliterans Syndrome (BOS) after lung transplantation. BOS is a long term (chronic) rejection process that can occur in the transplanted lungs.
This study is an extension study for participants who have completed participation in the BOSTON-1 or BOSTON-2 studies which investigated BOS after single or double lung transplantation.
Cyclosporine A inhibits the immune reaction against the transplanted organ. The oral use of cyclosporine A in transplanted patients is well-established for over 20 years. It is expected that the inhaled use of liposomal cyclosporine A will be more efficient for transplanted lungs.
The study drug will be provided in glass vials containing 10mg L-CsA, which is to be mixed with 2.4 mL saline. The resulting solution is poured into the PARI eFlow nebuliser device for inhalation.
The study will investigate patients taking two inhalations of nebulised L-CsA per day, one in the morning and one in the evening, for up to 144 weeks in addition to standard of care therapy.
After the first visit participants will attend 9 further visits every 4 to 12 weeks, then subsequent visits every 24 weeks until the study drug is approved for use if warranted. These visits will include physical tests, breathing tests and blood samples will be taken. They will also be asked to attend an end of study visit.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
21/EM/0229
Date of REC Opinion
16 Dec 2021
REC opinion
Further Information Favourable Opinion