Clinical trial NCT01044667: A Gastrointestinal Quality of Life Study in Lung Transplant Recipients Converted From Mycophenolate Mofetil to Myfortic
Official title: Reduced Gastrointestinal Complaints and Improved Quality of Life in Lung Transplant Recipients Converted From Mycophenolate Mofetil (MMF) to Myfortic (Enteric-coated Mycophenolate Sodium, Ec-mps)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Transplantation
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2010-01-08
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The primary objective of this study is to evaluate gastrointestinal (GI) symptoms and health related quality of life in lung transplant recipients converted from Mycophenolate Mofetil (MMF) to Myfortic as part of standard immunosuppressive therapy.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Change in Gastrointestinal Quality of Life Index (GIQLI), Baseline to 60 days:
timeFrame: Change from Baseline to 60 days
measure: Change in SF-36 Health Survey, Baseline to 60 days
timeFrame: Change from Baseline to 60 days
measure: Change in EQ-5D Health Questionnaire, Baseline to 90 days
timeFrame: Change from Baseline to 60 days
Secondary outcomes:
measure: Gastrointestinal Quality of Life Index (GIQLI)
timeFrame: Day 90 and Day 180
measure: SF-36 Health Survey
timeFrame: Day 90 and Day 180
measure: EQ-5D Health Questionnaire
timeFrame: Day 90 and Day 180
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medcial Center
name: Eric Lambright, MD
role: PRINCIPAL_INVESTIGATOR
References: