Azathioprine and Prednisone in the Treatment of Idiopathic Pulmonary Fibrosis
Status:
Unknown status
Trial end date:
2008-12-01
Target enrollment:
Participant gender:
Summary
Idiopathic pulmonary fibrosis (IPF) is a diffuse lung disease, associated with the
histological appearance of usual interstitial pneumonia (UIP), with an inexorably
deteriorating clinical course. Prognosis is poor, reported median survival is less than 3
years. The prevalence is estimated as being 3 to 10 per 100.000 in different Western
populations. To date, no pharmacological therapy has been proven to alter or reverse the
pathogenic process of IPF. Most treatments trials have been observational case series of
small patient populations and very few have been randomized, prospective and
placebo-controlled.
Two recent Cochrane reviews investigated the role of corticosteroids and other
immunomodulatory agents and concluded that there is no evidence for their use in IPF. Most
current therapies are targeted to suppress the inflammatory component of the disease, based
on the theory that it would be chronic alveolar inflammation which leads to parenchymal
remodeling and fibrosis. Recently, a hypothesis that has gained acceptance suggests that
fibrosis may result directly from alveolar injury, promoting an abnormal fibrogenic repair
mediated by fibroblasts and myofibroblasts.
One of the cytotoxic agents most widely used and better tolerated in the management of IPF is
azathioprine. Based upon limited data available and from a single small high quality
randomized controlled trial (RCT), this drug appears to confer, given in conjunction with
prednisone, a marginal long term survival advantage. Since this combination therapy is
associated serious adverse effect, we planned to design a trial of low dose corticosteroid
and azathioprine versus placebo in management of IPF, evaluating progression-free survival.
Our study hypothesis is: Combined therapy with azathioprine and corticosteroids improves
progression-free survival in patients with the diagnosis of IPF.
Phase:
N/A
Details
Lead Sponsor:
Thorax National Institute
Collaborators:
Servicio de Salud Metropolitano Oriente, Ministerio de Salud de Chile Sociedad Chilena de Enfermedades Respiratorias