PT  - JOURNAL ARTICLE
AU  - Jaume Bordas-Martínez
AU  - Carmen Herranz
AU  - Vanesa Vicens-Zygmunt
AU  - Antonio Román
AU  - Cristina Berastegui
AU  - Piedad Ussetti
AU  - Rosalía Laporta
AU  - Julio Ancochea
AU  - Claudia Valenzuela
AU  - Alvaro Casanova
AU  - Emilio Ansótegui
AU  - Jose Antonio Rodríguez-Portal
AU  - Guadalupe Bermudo
AU  - Patricio Luburich
AU  - Roger Llatjós
AU  - Salud Santos
AU  - Jordi Dorca
AU  - Pilar Hereu
AU  - Miquel Àngel Pujana * Sharing Senior Position
AU  - Maria Molina-Molina * Sharing Senior Position
TI  - Design of phase II, randomized, placebo-controlled study of loratadine associate with rapamycin in patients with lymphangioleiomyomatosis (LAM)
AID  - 10.1183/13993003.congress-2020.3401
DP  - 2020 Sep 07
TA  - European Respiratory Journal
PG  - 3401
VI  - 56
IP  - suppl 64
4099  - http://erj.ersjournals.com/content/56/suppl_64/3401.short
4100  - http://erj.ersjournals.com/content/56/suppl_64/3401.full
SO  - Eur Respir J2020 Sep 07; 56
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).