Status:
UNKNOWN
Dry Powder Inhalation of Cyclosporine A in Lung Transplant Patients With Bronchiolitis Obliterans Syndrome
Lead Sponsor:
University Medical Center Groningen
Conditions:
Lung Transplantation
Bronchiolitis Obliterans
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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 fro...
Detailed Description
Because calcineurin inhibitors are not completely effective in a full prevention of acute rejection and the corresponding chronic disfunction of the transplanted organ (Bronchiolitis Obliterans Syndro...
Eligibility Criteria
Inclusion
- 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
- Cyclosporine as maintenance therapy
- Bronchiolitis Obliterans Syndrome 0: FEV1\>80%
- Renal failure: Glomerular Filtration Rate \< 30 ml/min
- Chronic airway infections
- Clinical stability
- Pregnancy
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00378677
Start Date
February 1 2007
Last Update
February 7 2007
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Medical Center Groningen
Groningen, Netherlands