RecruitingPhase 2ACTRN12608000325303
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
Sponsor
Dr.Deborah Yates
Enrollment
30 participants
Start Date
Jan 10, 2008
Study Type
Interventional
Conditions
Eligibility
Sex: FemalesMin Age: 18 Yearss
Inclusion Criteria4
- 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 Criteria14
- 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
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Interventions
Doxycycline: 100mgs daily, oral for 6 months, washout period of 4 weeks between treatments
Doxycycline: 100mgs daily, oral for 6 months, washout period of 4 weeks between treatments
Locations(1)
View Full Details on ANZCTR
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ACTRN12608000325303
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