Dry Powder Inhalation of Cyclosporine A in Lung Transplant Patients With Bronchiolitis Obliterans Syndrome

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate whether dry powder inhalation of Cyclosporine A is beneficial in lung transplant patients with Bronchiolitis Obliterans Syndrome. For patients suffering from this syndrome often no therapeutic options are available. Furthermore, the side effects of the maintenance therapy leaves no room for dose increments. The hypothesis for this trial is that when Cyclosporine A is administered locally (in the lungs) chronic rejection can be treated more effectively without extra systemic side effects.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Center Groningen
• Treatments: Cyclosporine; Cyclosporins

Criteria

Inclusion Criteria:

• Signed Informed Consent

• Primary lung transplant

• Tacrolimus as maintenance therapy

• Bronchiolitis Obliterans Syndrome stages 1 - 3: FEV1<80% of baseline

• At least 3 months after last usual BOS intervention

• Declining FEV1 after last usual BOS intervention

Exclusion Criteria:

• Cyclosporine as maintenance therapy

• Bronchiolitis Obliterans Syndrome 0: FEV1>80%

• Renal failure: Glomerular Filtration Rate < 30 ml/min

• Chronic airway infections

• Clinical stability

• Pregnancy