Status:
COMPLETED
Doxycycline In Lymphangioleiomyomatosis (LAM)
Lead Sponsor:
University of Nottingham
Conditions:
Lymphangioleiomyomatosis
Tuberous Sclerosis
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
The purpose of the study is to test if the drug doxycycline is effective in slowing the progression of lung disease in LAM. Lymphangioleiomyomatosis (LAM) is a rare lung disease which affects young wo...
Detailed Description
Summary We will perform a 2 year double blind, placebo controlled trial of doxycycline in 40 patients with LAM. The main endpoints will be change in FEV1, other measures of efficacy, safety and dose ...
Eligibility Criteria
Inclusion
- 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 TSC consensus criteria(13).
- 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 enrollment.
- progesterone, GnRh agonists and bronchodilators
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00989742
Start Date
July 1 2009
End Date
January 1 2013
Last Update
December 2 2015
Active Locations (1)
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1
Nottingham University Hospitals
Nottingham, Nottingham, United Kingdom, NG7 2UH