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

• Conditions: ymphangioleiomyomatosis; MedDRA version: 9.1Level: LLTClassification code 10049459Term: Lymphangioleiomyomatosis; MedDRA version: 9.1Level: PTClassification code 10049459Term: Lymphangioleiomyomatosis

• Registration Number: EUCTR2007-003745-32-GB
• Lead Sponsor: niversity of Nottingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-26
• Last Update Posted: 30 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

•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

Exclusion Criteria

•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified