Study to Evaluate Adenosine 2A Receptor Agonist (Regadenoson) in Patients Undergoing Lung Transplantation

Lung transplantation currently is one way to treat a variety of serious diseases and
conditions such as emphysema, pulmonary fibrosis, and cystic fibrosis. Ischemia Reperfusion
Injury (IRI) is a known problem that can happen during the first few days after a lung
transplant. IRI can cause swelling of the lungs and low levels of oxygen. The most serious
type of IRI can cause the transplanted lung to not work properly, it can even cause death.
While new treatments and practices have been put into place to lower the chances of IRI, it
is still a difficult problem to overcome after a lung transplant.

Medicines called Adenosine 2A receptors (A2AR) have been studied in animals with IRI for many
years. Some of these studies suggest that with the use of A2AR medicines, the chance of IRI
may be lowered or prevented. Regadenoson is an A2AR drug.

Inclusion Criteria:

- Subjects must be undergoing a bilateral lung transplantation for end-stage lung
disease and thus meet all criteria to be listed

- Male or female subject, 18 -70 years of age

- Subjects must sign a study specific informed consent prior to study entry

- Subjects must meet all of the following laboratory values:

1. hemoglobin ≥ 6 g/dL,

2. platelets > 75,000/mcL,

3. aspartate aminotransferase (AST/SGOT)/ alanine aminotransferase (ALT /SGPT) < 2.5
X institutional upper limit of normal,

4. serum creatinine < 1.5 mg/dL,

5. INR < 1.5, PTT < 40 seconds

Exclusion Criteria:

- Subject requires preoperative extracorporeal membrane oxygenation (ECMO)

- Subject has second degree (Mobitz type I or II) or third-degree AV block or sinus node
dysfunction

- Subject has history of a bleeding diathesis

- Subject has a history of clinically overt stroke within the past 3 years

- Subject has a history of severe hypertension not adequately controlled with
anti-hypertensive medications (Systolic blood pressure ≥ 200 mmHg and/or Diastolic
blood pressure ≥ 110 mmHg)

- Subjects who are receiving chronic anti-coagulation or anti-platelet therapy that
would preclude surgery (prophylactic aspirin is acceptable)

- Subjects with a history of metastatic cancer

- Subjects with a history of seizure disorder

- Subjects who are receiving or have received within 30 days any other investigational
agents

- Subjects who have received theophylline or aminophylline within 12 hours of study
dosing