BOSTON-1

• Research type

  Research Study

• Full title

  A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care versus Standard of Care Alone in the Treatment of Bronchiolitis Obliterans Syndrome in Patients post Single Lung Transplantation

• IRAS ID

  256929

• Contact name

  Jasvir Parmar

• Contact email

  jas.parmar@nhs.net

• Sponsor organisation

  BREATH Therapeutics Inc.

• Eudract number

  2018-003204-39

• Clinicaltrials.gov Identifier

  NCT03657342

• Duration of Study in the UK

  1 years, 10 months, 0 days

• Research summary

  This study is designed to obtain information on the 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 lung.
  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 will compare 2 groups:
  Group 1: Two inhalations of nebulised L-CsA per day for 48 weeks in addition to standard of care therapy
  Group 2: Standard of care therapy for 48 weeks
  The study drug will be provided in glass vials containing 5mg L-CsA, which is to be mixed with 1.2 mL saline. The resulting solution is poured into the PARI eFlow nebuliser device for inhalation.
  The eFlow nebuliser device utilises a new technology of nebulising liquid drugs with a perforated vibrating membrane resulting in an aerosol with a high percentage of droplets in a breathable size range. The eFlow nebuliser used in the present study is a modified version of the eFlow®rapid device. It has been modified for an optimised delivery of L-CsA.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  19/EE/0236

• Date of REC Opinion

  1 Oct 2019

• REC opinion

  Further Information Favourable Opinion