Lymphangioleiomyomatosis MedDRA version: 9.1 Level: LLT Classification code 10049459 Term: Lymphangioleiomyomatosis MedDRA version: 9.1 Level: PT Classification code 10049459 Term: Lymphangioleiomyomatosis
Conditions
Interventions
Trade Name: Doxycycline 100 mg Capsules
Pharmaceutical Form: Capsule*
INN or Proposed INN: doxycycline
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmace
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does doxycycline prevent matrix metalloproteinase dependent tissue destruction in lymphangioleiomyomatosis (LAM) thus preserving lung function, exercise capacity and quality of life in LAM?;Secondary Objective: (1) determine the optimum dose of doxycycline needed to suppress MMP production (2) define the safety profile of doxycycline in LAM (3) provide evidence of efficacy and size of effect (4) determine the optimum design and logistics of future trials. ;Primary end point(s): Mean rate of change of FEV1/year over 24 months on doxycycline compared with placebo. | — |
Countries
United Kingdom
Outcome results
None listed