Overview

Safety and Efficacy Study of Nitric Oxide in Patients Going Through Lung Transplantation

Status:
Completed
Trial end date:
2008-06-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to assess the safety and efficacy of inhaled nitric oxide in prevention of lung graft dysfunction due to ischemia-reperfusion
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mallinckrodt
Treatments:
Nitric Oxide
Criteria
Inclusion Criteria:

- Have a lung graft scheduled

- Males and females aged 18 to 65

- Signed informed consent approved by the IRB/EC

Exclusion Criteria:

- Uncontrolled bacterial infection

- Creatinine clearance <50 ml/min

- Severe extrapulmonary organic dysfunction

- Continuing smoking habit

- Neoplastic disease (2-5 years free of tumor, depending on type)

- Pregnancy or nursing

- Severe osteoporosis

- Active peptic ulcer

- Progressive neuromuscular disease

- Active limiting systemic disease. Complicated diabetes.

- Any contraindication based on the judgement of the investigator