NCT03473340

Studying the Treatment Effect of Pirfenidone in Chronic Lung Allograft Dysfunction (STOP-CLAD)

A Phase Two Randomized, Double-blinded, Placebo-controlled Study Combining Physiological, Radiographic, and Biological Biomarkers to Study the Anti-fibrotic Effect of Pirfenidone in CLAD Post Lung-transplantation

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Disorder Related to Lung Transplantation
• Chronic Lung Allograft Dysfunction

Interventions

Type	Name	Description
DRUG	Pirfenidone Capsule	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
DRUG	Placebo Capsule	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

Timeline

• Start date: 2018-04-27
• Primary completion: 2021-07-23
• Completion: 2021-08-20
• First posted: 2018-03-22
• Last updated: 2022-08-17
• Results posted: 2022-08-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study