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 (SOC), 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 patient support groups (LAM foundation, AELAM)