BOSTON-2

• 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 Double Lung Transplantation

• IRAS ID

  257486

• Contact name

  Jasvir Parmar

• Contact email

  jas.parmar@nhs.net

• Sponsor organisation

  Zambon SpA

• Eudract number

  2018-003205-25

• Clinicaltrials.gov Identifier

  NCT03656926

• Duration of Study in the UK

  1 years, 8 months, 8 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 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 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 eFlow nebuliser device utilises a new technology of nebulising liquid drugs with a perforated vibrating membrane resulting in an aerosol (spray) with a high percentage of droplets in a breathable size range. The eFlow nebulizer 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 Midlands - Leicester South Research Ethics Committee

• REC reference

  19/EM/0250

• Date of REC Opinion

  11 Sep 2019

• REC opinion

  Further Information Favourable Opinion