L-CsA in the Prevention of Bronchiolitis Obliterans Syndrome (BOS) in Lung Transplant (LT) Patients

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

Summary

Immunosuppression is a key intervention in patients with solid organ transplant and is usually achieved by combination therapy with systemic CsA or tacrolimus with azathioprine, mycophenolate mofetil (MMF), or corticoids. However, the outcomes after lung transplantation are poor when compared with those after heart, kidney, or liver transplantation, with a survival rate of only 55% for recipients of lung transplants.

Additional application of aerosolised L-CsA should suppress T-cell activation in the lung tissue and subsequently BOS development. The overall purpose of this phase-II/III study is to obtain efficacy and safety data of L-CsA in the prevention of BOS.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pari Pharma GmbH
• Treatments: Cyclosporine; Cyclosporins

Criteria

Inclusion Criteria:

1. Patient's written informed consent

2. Received a single lung, bilateral lung or heart/lung transplantation between 6 weeks and 26 weeks prior to first IMP administration.

3. Male or female, 18 years of age

4. Capable of self-administration of medications

5. Capable of understanding the purpose and risk of the clinical trial

6. Received the following immunosuppressive agents and dosages for maintenance therapy:

1. Tacrolimus and

2. Mycophenolate mofetil (MMF) 1 to 3 g/day and

3. Prednisone or any other steroid therapy; tapered down

7. Female patients with childbearing potential must have a negative urine pregnancy test prior to first IMP administration.

8. Estimated life expectancy > 6 month

Exclusion Criteria:

1. Any previous episode of bronchiolitis obliterans (BO) or bronchiolitis obliterans syndrome (BOS) of grade 1 or higher

2. Any active invasive bacterial, viral or fungal infection

3. Received systemic maintenance immunosuppressive therapy other than listed in the inclusion criteria

4. Received any systemic or topical ciclosporin A within

5. Received any systemic or topical Rosuvastatin

6. Current mechanical ventilation

7. Received a lung re-transplantation

8. Pregnant or breast feeding woman

9. Has known hypersensitivity to ciclosporin A

10. Has a serum creatinine value of more than 265 µmol/L (3 mg/dL)

11. Unlikely to comply with visits, inhalation procedures or spirometric measurements

12. Receipt of an investigational drug within 4 weeks prior to first administration of IMP

13. Any co-existing medical condition that in the investigator's judgement

14. Psychiatric disorders or altered mental status

15. Patient was previously enrolled in the present clinical trial