NCT01462006

Double-blind Placebo-controlled Pilot Study of Sirolimus in Idiopathic Pulmonary Fibrosis (IPF)

Double-blind Placebo-controlled Pilot Study of Sirolimus in IPF

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Idiopathic pulmonary fibrosis (IPF) is an illness characterized by progressive decline in lung function and premature death from respiratory failure. Fibrocytes are a novel population of bone marrow-derived circulating progenitor cells that have been shown to traffic to the lungs and contribute to fibrosis in animal models of pulmonary fibrosis, and whose numbers correlate with the degree of fibrosis and with survival in human pulmonary fibrosis. The investigators propose to test the hypothesis that therapy with the mTOR inhibitor, sirolimus, reduces the number of circulating fibrocytes in patients with IPF. The investigators propose to test this hypothesis in short-term pilot trial of sirolimus in patients with IPF to determine its effect on the number and phenotype of circulating fibrocytes.

Conditions

• Idiopathic Pulmonary Fibrosis
• Diffuse Parenchymal Lung Disease
• Interstitial Lung Disease

Interventions

Type	Name	Description
DRUG	sirolimus	randomized to drug or placebo, followed by washout, followed by crossover
OTHER	Placebo	randomized to drug or placebo, followed by washout, followed by crossover

Timeline

• Start date: 2011-10-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2011-10-28
• Last updated: 2021-03-22

Locations

1 site across 1 country: United States