The purpose of this study is to evaluate long-term safety of L-CsA in prevention of bronchiolitis obliterans syndrome (BOS) following lung transplantation (LTx) in patients previously enrolled in phase II/III L-CsA clinical trial 12011.201.
This is an uncontrolled extension study open only to patients who completed the Phase II/III core study 12011.201 and volunteered to continue or to cross-over to L-CsA inhalation therapy. Determination of long-term safety and efficacy outcome over a maximum of three years will be assessed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
14
Twice daily inhalation for a maximum of three years.
PARI Pharma GmbH
Gräfelfing, Germany
Long-term safety of L-CsA in prevention of bronchiolitis obliterans syndrome (BOS)
Safety will be assesses by the numbers of treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) and overall rate of mortality.
Time frame: 3 years
Long-term efficacy outcome over a maximum of three years of patients previously enrolled in phase II/III L-CsA clinical trial 12011.201
Efficacy will be assessed mainly for the following efficacy endpoints: * BOS-free survival * Incidence of BOS * Pulmonary function
Time frame: 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.