A randomised, double blind, placebo controlled trial of doxycycline in lymphangioleiomyomatosis. - Doxycycline in LAM

niversity of Nottingham0 个研究点开始时间: 2010年11月26日最近更新: 2014年6月30日

研究概览

暂无简介。

•Sporadic LAM diagnosed either by cystic lung disease on HRCT classical of LAM plus angiomyolipoma or chylous effusion or cystic lung disease on HRCT and tissue biopsy showing LAM or angiomyolipoma
•TSC-LAM diagnosed by cystic lung disease on HRCT and tuberous sclerosis diagnosed by modified Gomez criteria.
•Patients with either an FEV1 below 80% predicted or evidence of a 20% deterioration in FEV1.
•Hormone and bronchodilator treatment for LAM* is allowed providing treatment has not changed in the three months prior to enrolment.
•* progesterone, GnRh agonists and bronchodilators.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Inability to give informed consent.
•Mental retardation.
•Age less than 18 years.
•Pneumothorax, chylous effusion, bleeding angiomyolipoma or change in hormone treatment within 3 months.
•Previous organ transplantation.
•Severe or uncontrolled epilepsy.
•Use of any oral contraceptive pill.
•Pregnancy or breast feeding. Pre-menopausal patients must be willing to use appropriate birth control measures to avoid pregnancy while enrolled in the study.
•Major systemic diseases (malignancy, myocardial infarction or unstable angina, type1 diabetes, severe hypertension, liver cirrhosis).
•Use of drugs known to interact with doxycycline, including anticoagulation with warfarin.
•Anticoagulation with warfarin.
•Hypersensitivity to tetracyclines.
•Treatment with mTOR inhibitor within the previous 3 months (sirolimus, everolimus).
•Use of doxycycline or other experimental drug within the previous three months.

发起方

niversity of Nottingham