Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001877
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Treatment of Pulmonary Sarcoidosis With Pentoxifylline
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Treatment of Pulmonary Sarcoidosis With Pentoxifylline
Status:
COMPLETED
Status Verified Date:
2004-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Sarcoidosis is a disease most commonly affecting the lungs but it can also involve lymph nodes skin liver spleen eyes bones and glands The cause of the disease is unknown When it occurs it can produce an inflammatory reaction leading to irreversible organ damage and disability
In sarcoidosis granulomas can form in various organs primarily lung which can lead to its dysfunction Granuloma is formed by clusters of inflammatory cells The formation of these granulomas is influenced by the release of a substance called TNF-alpha tumor necrosis factor alpha which is found in some white blood cells A drug known as pentoxifylline POF is known to markedly reduce the release of TNF-alpha
The standard medical treatment for sarcoidosis is steroid therapy However steroid therapy is associated with significant side effects and often must be stopped Unfortunately some of these patients can relapse when the steroid therapy is discontinued Because of this researchers are interested in finding alternative therapies for the treatment of sarcoidosis
This study will evaluate the effectiveness of giving POF to patients with sarcoidosis currently taking steroids Researchers will compare the results between patients taking steroids with pentoxifylline and those patients taking steroids alone
In sarcoidosis granulomas can form in various organs primarily lung which can lead to its dysfunction Granuloma is formed by clusters of inflammatory cells The formation of these granulomas is influenced by the release of a substance called TNF-alpha tumor necrosis factor alpha which is found in some white blood cells A drug known as pentoxifylline POF is known to markedly reduce the release of TNF-alpha
The standard medical treatment for sarcoidosis is steroid therapy However steroid therapy is associated with significant side effects and often must be stopped Unfortunately some of these patients can relapse when the steroid therapy is discontinued Because of this researchers are interested in finding alternative therapies for the treatment of sarcoidosis
This study will evaluate the effectiveness of giving POF to patients with sarcoidosis currently taking steroids Researchers will compare the results between patients taking steroids with pentoxifylline and those patients taking steroids alone
Detailed Description:
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 productionrelease 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-H-0057 | None | None | None |