None listed
Conditions
Interventions
RAD 4mg po Bd
Sponsors
Dr Monique Malouf
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
A diagnosis of pulmonary fibrosis who are eligible to receive RAD. Patients capable of understanding the purposes and risks of the study and who give informed written consent.
Exclusion criteria
i. Patients receiving immunosuppression other than study medication. NB patients receiving a mean dose of 10mg Prednisolone / day or steroid equivalent and who have been on a stable dose for at least 4 weeks will be allowed entry into the trial. ii. Pregnant women, nursing mothers.iv.Female/Male patients unwilling to maintain adequate birth-control during and for 3 months following the conclusion of study.iv. Patients with active malignancies or a history of malignancy with a recurrence free interval of 5 years (except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully).v. Patients with serological evidence of HIV, HbsAg or HCV antibodies.vi. Patients with respiratory failure requiring invasive ventilation.vii.Patients with systemic infections requiring therapy at the time of entry into the study. A systemic infection is defined as a body temperature of 38 degrees or above on 2 occasions, or 39 degrees accompanied by a positive culture of body fluid regarded as significant by the local laboratory which requires antibiotic therapy.viii. Patients with a concomitant major illness such as (a) cardiac or (b) renalinsufficiency (creatinine clearance 0ml/min).ix. Patients with severe uncontrolled hypercholesterolemia (9.1 mmol/L) (350mg/dL) or hypertriglyceridemia (5.6 mmol/L) (500mg/dL).x. Patients with a history of significant coagulopathy or a medical condition requiring long term systemic anticoagulation. Low dose aspirin will be allowed.
Outcome results
None listed