Follow-up Study in the Prevention of BOS.

• Research type

  Research Study

• Full title

  (A phase II/III) Long-term safety follow-up study of L-CsA therapy for patients who participated in study 12011.201 and volunteered to continue or to cross-over to L-CsA inhalation therapy.

• IRAS ID

  102716

• Contact name

  Jasvir Parmar

• Sponsor organisation

  PARI Pharma GmbH

• Eudract number

  2011-004304-38

• Clinicaltrials.gov Identifier

  NCT01439958

• Research summary

  This is a study for patients who participated in the ongoing study 12011.201 and volunteer to continue or to cross-over to L-CsA inhalation therapy. Patients will be invited to participate in an open-label research extension study because they will have recently completed the previous L-CsA clinical trial (study no. 12011.201). This follow-on study is designed to obtain information about the long-term safety of an experimental drug called Aerosolised Liposomal Ciclosporin A (L-CsA) when it is given to patients to prevent the development of Bronchiolitis Obliterans Syndrome. Bronchiolitis Obliterans Syndrome (BOS) is a long term (chronic) rejection process that can occur in the transplanted lung.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  12/EE/0192

• Date of REC Opinion

  14 Jun 2012

• REC opinion

  Further Information Favourable Opinion