Treatment of Pulmonary Sarcoidosis With Pentoxifylline
Corticosteroids are currently the mainstay of therapy for active pulmonary sarcoidosis and
are used to prevent relapses in many patients with stable disease. The pulmonary
manifestations of sarcoidosis are heterogenous and not all patients require corticosteroid
therapy. Corticosteroids often produce undesirable side effects and, therefore, other
therapies that can reduce or replace corticosteroid use are being sought. As tumor necrosis
factor-alpha (TNF-alpha) plays a pivotal role in the formation of granulomata (the
pathological hallmark of the disease), drugs that inhibit its production/release may prove
effective in the treatment of this disease. Pentoxifylline (POF), a xanthine derivative
used for many years in the treatment of peripheral vascular disease, is known to inhibit
TNF-alpha release by human peripheral blood mononuclear cells and alveolar macrophages from
patients with active sarcoidosis. To evaluate whether this drug is beneficial in the
treatment of sarcoidosis, we propose to conduct a randomized, double-blind,
placebo-controlled trial with POF in patients with pulmonary sarcoidosis on corticosteroid
therapy. The primary objective of this study is to determine whether POF treatment can be
beneficial as an adjunct to corticosteroid therapy in patients with pulmonary sarcoidosis.
The role of TNF-alpha and other cytokines (released from alveolar macrophages) in explaining
treatment responses defined by whether or not a patient improved will be assessed by testing
whether the effect of treatment on the probability of improvement varies with cytokine
levels.
Interventional
Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
United States: Federal Government
990057
NCT00001877
February 1999
May 2004
Name | Location |
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National Heart, Lung and Blood Institute (NHLBI) | Bethesda, Maryland 20892 |