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Treatment of Pulmonary Sarcoidosis With Pentoxifylline

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001877
First Posted: November 4, 1999
Last Update Posted: March 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  Purpose

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.


Condition Intervention Phase
Pulmonary Sarcoidosis Drug: Pentoxifylline Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Treatment of Pulmonary Sarcoidosis With Pentoxifylline

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 100
Study Start Date: February 1999
Estimated Study Completion Date: May 2004
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 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  1. Admission to this protocol will require a diagnosis of pulmonary sarcoidosis with or without ocular sarcoidosis based on clinical history, and biopsy of either lung, intrathoracic or other lymph nodes, or internal organs consistent with sarcoidosis, with all other causes of granuloma ruled out. Prior to enrollment in the study, patients will have their biopsy slides reviewed by a pathologist for confirmation of the diagnosis.
  2. Males or females between 18 and 70 years of age on corticosteroid therapy.

EXCLUSION CRITERIA:

  1. Patients with active sarcoidosis of major organs other than the lungs and eyes (e.g., central nervous system, cardiac, renal) that require corticosteroid therapy.
  2. Patients with uncontrolled hypertension, uncontrolled diabetes, history of cerebral or retinal hemorrhage, heart failure (New York class III or higher), renal failure (on dialysis), liver failure (with portal hypertension and ascites), cancer EXCEPT non-metastatic basal or squamous cell carcinoma of the skin, hematologic disorders, including severe anemia (hemoglobin less than or equal to 7 g/dl), granulocytopenia, platelet disorders, or a need for anticoagulation therapy.
  3. Patients with concomitant obstructive lung disease (i.e., asthma, COPD, cystic fibrosis) or other interstitial lung diseases since changes in pulmonary function in such patients could not be attributed to sarcoidosis alone.
  4. Patients who are pregnant or lactating.
  5. Women of child-bearing potential without an accepted method of birth control.
  6. Patients with a positive serum test for human immunodeficiency virus or hepatitis B or C virus.
  7. Patients incapable of giving informed consent.
  8. Patients allergic to POF or methylxanthines such as caffeine, theophylline and theobromine.
  9. Patients currently taking corticosteroids for disease other than pulmonary sarcoidosis, theophylline, POF, or other xanthines, or patients who have been on these drugs in the preceding three months.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001877


Locations
United States, Maryland
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001877     History of Changes
Other Study ID Numbers: 990057
99-H-0057
First Submitted: November 3, 1999
First Posted: November 4, 1999
Last Update Posted: March 4, 2008
Last Verified: May 2004

Keywords provided by National Institutes of Health Clinical Center (CC):
Tumor Necrosis Factor
Corticosteroids
Macrophages
Phosphodiesterase
Autoimmune
Pulmonary Sarcoidosis

Additional relevant MeSH terms:
Sarcoidosis
Sarcoidosis, Pulmonary
Lymphoproliferative Disorders
Lymphatic Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Pentoxifylline
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Free Radical Scavengers
Antioxidants