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

• Status: Terminated
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pari Pharma GmbH

Criteria

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

4. Estimated life expectancy > 6 months

5. Capable of self-administration of medications

6. Patient has stable creatinine levels

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