Greater than 50% of lung transplant recipients show signs of chronic lung allograft dysfunction (CLAD) by 5 years post-transplantation.Therapies to prevent or slow CLAD are lacking. Anti-fibrotic therapies may offer an avenue to prevent progression of CLAD and prolong allograft survival. This study investigates if Pirfenidone therapy will stabilize lung function decline and slow progression of Functional small airways disease (fSAD) in lung transplant recipients with CLAD.
The study aimed to enroll lung transplant recipients with an established diagnosis of CLAD. The patients were randomized to receive an anti-fibrotic drug Pirfenidone or Placebo pills for 6 month period. High-resolution CT scan of the chest was utilized to measure the primary endpoint of change in functional small airway disease (fSAD). Pulmonary function testing and spirometry were utilized to measure the secondary endpoint of change in FEV1 and FVC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Dosing: Days 1 through 7, 267 mg three times daily; Days 8 through 14, 534 mg three times daily; Days 15 through end of treatment (24 weeks), 801 mg three times daily duration: 24 weeks
Dosing: * Days 1 through 7, 267 mg three times daily; * Days 8 through 14, 534 mg three times daily; * Days 15 through end of treatment (24 weeks), 801 mg three times daily duration: 24 weeks
The University of Michigan
Ann Arbor, Michigan, United States
Change in Percent of Functional Small Airways Disease (fSAD) as Measured by Parametric Response Mapping
Evaluate if pirfenidone compared to placebo will stabilize progression of fSAD by comparison of inspiratory and expiratory high resolution computed tomography (HRCT) images through co-registration to provide quantitative measures of fSAD.
Time frame: Baseline, 24 weeks
Change in Forced Expiratory Volume 1 Over 24 Weeks (FEV1)
Measured by spirometry
Time frame: Baseline, 24 weeks
Change in Forced Vital Capacity (FVC) Over 24 Weeks
Measured by spirometry
Time frame: Baseline, 24 weeks
Number of Adverse Events Related to Study Treatment
Safety of pirfenidone will be measured by adverse events determined to be related to the study drug through review of medical history, physical exam and laboratory findings.
Time frame: 28 weeks
Number of Subjects With Treatment Intolerance
Subjects permanently discontinuing study medication before 24 weeks
Time frame: 24 weeks
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