An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsA

• Conditions: Prevention of Bronchiolitis Obliterans Syndrome in lung transplant; MedDRA version: 14.1Level: LLTClassification code 10049202Term: Bronchiolitis obliteransSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-004304-38-ES
• Lead Sponsor: PARI Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-22
• Last Update Posted: 2 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1.Patient has completed the L-CsA clinical trial 12011.201
2.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
3.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(see Appendix 3)
4.Estimated life expectancy > 6 months
5.Capable of self-administration of medications
6.Patient has stable creatinine levels
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

1.Patients with ongoing irreversible L-CsA related serious adverse events
2.Patients with known hypersensitivity for ciclosporin A
3.Patient intends to participate in another IMP clinical trial other than listed in the inclusion criteria
4.Patient receives mechanical ventilation
5.Patients underwent pulmonary re-transplantation
6.Patient is a pregnant or breast-feeding woman
7.Patient is unlikely to comply with visits, inhalation procedures or spirometric measurements scheduled in the protocol
8.Patient receives any systemic or topical Rosuvastatin
9.Patient has been previously enrolled in this study
10.Patient with malignancy diagnosed during study 12011.201 (with the exception of skin cancer)
11.Documented respiratory infections unless on appropriate antimicrobial therapy with evidence of clinical response
12.Patient is not eligible to continue IMP inhalation according to the Investigator?s discretion

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of the study is to evaluate the 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.;Secondary Objective: In addition, the long-term efficacy outcome over a maximum of three years will be determined.;Primary end point(s): Safety Endpoints:<br>Safety will be assessed using the following parameters:<br>?Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (from inclusion into the 12011 203 study)<br>?Laboratory evaluations (chemistry, haematology and urinalysis) will be performed as scheduled by the local institution. Only abnormal and clinically relevant values will be recorded when they are reported<br>?Overall rate of mortality <br>?Vital signs<br>?Trough L-CsA and tacrolimus blood levels;Timepoint(s) of evaluation of this end point: Safety end-points will be evaluated throught the duration of the study.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Efficacy Endpoints: <br>Bronchiolitis obliterans syndrome (BOS):<br>?BOS-free survival<br>?Incidence of BOS<br>?Pulmonary function;Timepoint(s) of evaluation of this end point: Efficacy will be assessed using the following parameters:<br>?Time to occurrence of BOS (? grade 1), respectively BOS progression over the following time period<br>?Period of time starting from inclusion into study 12011.201 (Phase II/III) until occurrence of BOS ? grade 1, or death, or re-transplantation <br>Incidence of BOS (until end of study):<br>?Number and severity of BOS episodes from inclusion until end of study 12011.203 (Safety follow-up) <br>Pulmonary Function Tests (PFT) (at each clinic visit):<br>?Forced Expiratory Volume in one second (FEV1).<br>?Forced Midexpiratory Flow (FEF25-75)