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

Doxycycline in Lymphangioleiomyomatosis: a randomised double blind placebo controlled crossover trial to study the safety and efficacy of doxycycline on lung function, exercise capacity, quality of life indices and cyst size in patients with LAM

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000325303

Enrollment

Registered

2008-07-14

Start date

2008-01-10

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Doxycycline: 100mgs daily, oral for 6 months, washout period of 4 weeks between treatments

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results