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Sirolimus in Lymphangioleiomyomatosis
NCT00414648Phase 3
Key facts
- Status
- Completed
- Start
- Dec 2006
- Primary completion
- Sep 2010
- Countries
- 3
- Sponsor
- University of Cincinnati
- Modality
- Small Molecules
- Drugs
- sirolimus
- Conditions
- lymphangioleiomyomatosis (LAM)
01
Overview
Phase 3, randomised, double-blind trial in lymphangioleiomyomatosis (LAM) comparing Sirolimus Arm with Placebo Arm (2 arms). Primary endpoint: Changes in Forced Expiratory Volume in One-second (FEV1) Slope. Started Dec 2006; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Sirolimus Arm
Sirolimus 2 mg daily
Placebo Arm
Placebo daily
03
Endpoints
Primary
Changes in Forced Expiratory Volume in One-second (FEV1) Slope
Secondary
Percent of Participants With Serious Adverse Events
Changes in FVC Slope
Rate of Change in Diffusing Capacity for Carbon Monoxide (DLCO)
Rate of Change in Total Lung Volume
Rate of Change in Six Minute Walk Distance
Rate of Change in Serum Vascular Endothelial Growth Factor-D (VEGF-D) Levels
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