Doxycycline in Lymphanioleiomyomatosis (LAM): a randomised double blind placebo controlled crossover trial

Phase 2

Recruiting

• Conditions: Lymphangioleiomyomatosis; ymphangioleiomyomatosis; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12608000325303
• Lead Sponsor: Dr.Deborah Yates

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-07-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

a.Aged 18 or over
b.Informed signed consent
c.Diagnosis of pulmonary LAM as determined preferably by biopsy, or chest CT scan findings compatible with LAM.
d.Abnormal lung function i.e. compatible with LAM. There will be no FEV1 exclusion criterion

Exclusion Criteria

a.Pregnancy or breast feeding
b.Inadequate contraception
c.Significant gastrointestinal disease such as to interfere with drug absorption, or predispose to severe reflux oesophagitis
d.Uncontrolled systemic disease
e.Significant renal impairment
f.Use of an investigational drug within the last 30 days.
g.Previous lung transplantation
h.Inability to attend scheduled clinic visits
i.Inability to give informed consent
j.Inability to perform pulmonary function testing
k.Chylous ascites sufficient to affect diaphragmatic function
l.Pleural effusion sufficient to blunt the costophrenic angle on a PA chest roentgenogram.
m.Acute pneumothorax within the past 2 months
n.Documented allergy to study drugs

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Exercise capacity: 6 minute walk response[6 months, 1 year];Change in quality of life and Visual Analogue Score (VAS) dyspnoea scores[6 months, 1 year];Lung function: carbon monoxide diffusing capacity (DLCO), arterial blood gases, alveolar-arterial (A-a) gradient, total lung capacity (TLC), Residual volume (RV)/total lung capacity (TLC) <br>Change in size of lung cysts as assessed by a new automated computerised method.[6months, 1year]

Secondary Outcome Measures

Name	Time	Method
exhaled nitric oxide, exhaled breath condensate biomarkers, electronic nose (eNOSE) measurements[1 year];forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC)[1 year]