Bronchiolitis Obliterans Clinical Trial
Official title:
A 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
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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