RAD in the Treatment of Pulmonary Fibrosis
- Conditions
- Pulmonary FibrosisRespiratory - Other respiratory disorders / diseases
- Registration Number
- ACTRN12605000599673
- Lead Sponsor
- Dr Monique Malouf
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 120
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the efficacy and safety of RAD in the treatment of pulmonary <br>fibrosis. Efficacy is defined by stabilisation or improvement in baseline parameters of lung function; six-minute walk test distance (6MWT), resting arterial oxygen tension (PaO2), Quality of Life (QOL) score and Borg dyspnoea scale.[At intervals of 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 months from randomisation.]
- Secondary Outcome Measures
Name Time Method To assess the incidence and timing of the fall in lung function parameters.[From baseline.];To assess the incidence and timing of the development of respiratory failure and to assess survival.[At 6 months, 1 and 3 years.]