A Gastrointestinal Quality of Life Study in Lung Transplant Recipients Converted From Mycophenolate Mofetil to Myfortic

Subjects administered MMF as part of their immunosuppression regimen after lung
transplantation have a high incidence of GI symptoms related to the known side-effects of
this drug. Previous studies have shown that GI symptoms are an important predictor of health
related quality of life in other solid organ transplants (1). GI complications are common
after lung transplant (2). We hypothesize that lung transplant patients converted from MMF to
Myfortic will have significant reduction in severity of GI complaints. We also hypothesize
that improvement in the severity of GI complaints will lead to an improved quality of life in
these subjects. The study also includes data to evaluate the effect of GI complaints on
health related quality of life.

Patients will complete questionnaires at each visit. Calls from the patients to the lung
transplant center with GI complaints will be queried and documented on the case report form
by the research nurse at each study visit. Similarly, hospital admissions for GI related
complaints in the cohort will be documented. Symptom severity and health related quality of
life will be assessed through the following questionnaires that have previously been
validated in populations other than lung transplant (1). These questionnaires are selected
specifically to capture the impact of GI complaints as related to the health related quality
of life. The questionnaires that will be completed by the patient:

i.Gastrointestinal Quality of Life Index (GIQLI)

• The GIQLI is a 36-item questionnaire that assess the impact of GI distress on daily life

ii.SF-36 Health Survey • "The SF-36 Health Survey is a questionnaire that capture practical,
reliable, and valid information about functional health and well-being from the patients'
point of view" (4)

iii.EQ-5D Health Questionnaire

• "The EQ-5D is a standardized instrument for use as a measure of health outcome. The EQ-5D
provides a simple descriptive profile and a single value for health status" (5)

Patients will complete the three questionnaires at 4 outpatient visits occurring:

- when the patient comes in to an outpatient clinic visit after initial hospital discharge
after lung transplantation with complaints of GI distress (Day 1-Convert to Myfortic);

- 60 Days;

- 90 days;

- 180 days

Inclusion Criteria:

- Ability and willingness to provide written informed consent and adhere to study
regimen

- Recipients who are 18-70 years of age

- Patients who have undergone either single or double lung transplant are discharged on
the standard MMF (no generic MMF will be used) therapy and complain of GI symptoms,
thought to be related to their immunosuppressive regimen

Exclusion Criteria:

- Patients who have GI complaints thought to be due to factors other than
immunosuppressive regimen

- Patients receiving steroid treatment for acute rejection

- Women of childbearing potential who do not agree to use at least two acceptable forms
of contraception prior to starting study drug, while taking study drug, and for 6
weeks after stopping study drug

- Women who have a positive serum or urine pregnancy test at visit 1 and/or continuing
through the study