RT Journal Article SR Electronic T1 Design of phase II, randomized, placebo-controlled study of loratadine associate with rapamycin in patients with lymphangioleiomyomatosis (LAM) JF European Respiratory Journal JO Eur Respir J FD European Respiratory Society SP 3401 DO 10.1183/13993003.congress-2020.3401 VO 56 IS suppl 64 A1 Jaume Bordas-Martínez A1 Carmen Herranz A1 Vanesa Vicens-Zygmunt A1 Antonio Román A1 Cristina Berastegui A1 Piedad Ussetti A1 Rosalía Laporta A1 Julio Ancochea A1 Claudia Valenzuela A1 Alvaro Casanova A1 Emilio Ansótegui A1 Jose Antonio Rodríguez-Portal A1 Guadalupe Bermudo A1 Patricio Luburich A1 Roger Llatjós A1 Salud Santos A1 Jordi Dorca A1 Pilar Hereu A1 Miquel Àngel Pujana * Sharing Senior Position A1 Maria Molina-Molina * Sharing Senior Position YR 2020 UL http://erj.ersjournals.com/content/56/suppl_64/3401.abstract AB Introduction: LAM is a rare and lethal disease characterized by progressive cystic lung destruction. Inhibition of mTOR with rapamycin is the current standard of care, which can slow-down disease. Plasma major histamine metabolite (Methylimidazoleacetic acid [MIAA]) is increased in LAM. Loratadine is a histamine receptor antagonist (HR1), which inhibits LAM cell proliferation. Therefore, a novel phase-II clinical trial for assessing safety and potential benefits of loratadine in LAM has been initiated.Methods: LORALAM clinical trial, phase-II, double-blind, randomized, placebo controlled, parallel-group, multicentre study initiates recruitment in July 2020. Enrollment plan includes 62 subjects with LAM on treatment with rapamycin ≥3 months, randomized 1:1 to add oral loratadine 10mg/day or placebo, once daily, for 52 weeks. Recruitment will end in June 2021. The primary endpoints are 1) to assess the safety profile of loratadine associated with rapamycin, 2) lung function decline after 52 weeks of treatment. The secondary endpoints are a) quality of life and progression free-survival time, b) changes in the established LAM serum biomarker VEGFD, c) the utility of MIAA for monitoring disease progression and biological treatment effect.Ethics and Dissemination: The study will be carried out in accordance with Good Clinical Practice guidelines, Declaration of Helsinki principles, and each ethical committee. This clinical trial contemplates the possibility of increasing the number of centers and including patients from patients support groups (LAM foundation, AELAM).Clinicaltrials.gov registeredFootnotesCite this article as: European Respiratory Journal 2020; 56: Suppl. 64, 3401.This abstract was presented at the 2020 ERS International Congress, in session “Respiratory viruses in the "pre COVID-19" era”.This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).