Long-term Safety Follow-up Study in the Prevention of Bronchiolitis Obliterans Syndrome (BOS)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Bronchiolitis Obliterans

Intervention / Treatment
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* Drug: Inhalation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has completed the L-CsA clinical trial 12011.201 Patient is capable of understanding the purpose and risks of the follow-up study, has been fully informed and has given written informed consent to participate in the study Female patients of child bearing potential must test negative on standard urine pregnancy test prior to continuation and must agree to practice effective birth control during the study Estimated life expectancy > 6 months Capable of self-administration of medications Patient has stable creatinine levels Exclusion Criteria: Patients with ongoing irreversible L-CsA related serious adverse events Patients with known hypersensitivity for ciclosporin A Patient intends to participate in another IMP clinical trial other than listed in the inclusion criteria Patient receives mechanical ventilation Patients underwent pulmonary re-transplantation Patient is a pregnant or breast-feeding woman Patient is unlikely to comply with visits, inhalation procedures or spirometric measurements scheduled in the protocol Patient receives any systemic or topical Rosuvastatin Patient has been previously enrolled in this study Patient with malignancy diagnosed during study 12011.201 (with the exception of skin cancer) Documented respiratory infections unless on appropriate antimicrobial therapy with evidence of clinical response Patient is not eligible to continue IMP inhalation according to the Investigator's discretion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L-CsA<br>Twice daily inhalation of L-CsA | Drug: Inhalation<br>* Twice daily inhalation for a maximum of three years.<br>* Other names: aerosolized liposomal CsA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inhalation, Lung Transplantation, Cyclosporine