Resveratrol and Sirolimus in Lymphangioleiomyomatosis Trial

Summary

RESULT is a phase II dose-escalating, open-label, safety and efficacy study to determine if there is a potential benefit of resveratrol in combination with sirolimus in patients with lymphangioleiomyomatosis (LAM). The primary study objective is to assess the change in serum vascular endothelial growth factor-D (VEGF-D) level after 24 weeks of treatment with a combination of resveratrol and sirolimus as compared to the VEGF-D level in patients on a stable dose of sirolimus alone. The secondary objectives of this study include an assessment of the safety and adverse effect profile of combined resveratrol and sirolimus in adult patients with LAM, and to determine the effect of treatment with a combination of resveratrol and sirolimus on changes in lung function and quality of life.

Timeline

Start

2018-03-31

Primary completion

2022-10-15

Completion

2022-10-15

Publications

• Gupta N, Zhang B, Zhou Y, McCormack FX, Ingledue R, Robbins N, Kopras EJ, McMahan S, Singla A, Swigris J, Cole AG, Holz MK. Safety and Efficacy of Combined Resveratrol and Sirolimus in Lymphangioleiomyomatosis. Chest. 2023 May;163(5):1144-1155. doi: 10.1016/j.chest.2023.01.007. Epub 2023 Jan 13.

Drugs

Indications