Treatment of Pulmonary Sarcoidosis With Pentoxifylline

NCT00001877 | Completed Phase 2

• 2 other identifiers: 99005799-H-0057
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Sarcoidosis

Keywords

Tumor Necrosis Factor; Corticosteroids; Macrophages; Phosphodiesterase; Autoimmune; Pulmonary Sarcoidosis

Interventions

Pentoxifylline DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Males or females between 18 and 70 years of age on corticosteroid therapy.

You may not qualify if:

• Patients with active sarcoidosis of major organs other than the lungs and eyes (e.g., central nervous system, cardiac, renal) that require corticosteroid therapy.
• 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.
• 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.
• Patients who are pregnant or lactating.
• Women of child-bearing potential without an accepted method of birth control.
• Patients with a positive serum test for human immunodeficiency virus or hepatitis B or C virus.
• Patients incapable of giving informed consent.
• Patients allergic to POF or methylxanthines such as caffeine, theophylline and theobromine.
• 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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Heart, Lung and Blood Institute (NHLBI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Zabel P, Entzian P, Dalhoff K, Schlaak M. Pentoxifylline in treatment of sarcoidosis. Am J Respir Crit Care Med. 1997 May;155(5):1665-9. doi: 10.1164/ajrccm.155.5.9154873.

  PMID: 9154873 BACKGROUND

• Marques LJ, Zheng L, Poulakis N, Guzman J, Costabel U. Pentoxifylline inhibits TNF-alpha production from human alveolar macrophages. Am J Respir Crit Care Med. 1999 Feb;159(2):508-11. doi: 10.1164/ajrccm.159.2.9804085.

  PMID: 9927365 BACKGROUND

• Chesnutt AN. Enigmas in sarcoidosis. West J Med. 1995 Jun;162(6):519-26.

  PMID: 7618312 BACKGROUND

MeSH Terms

Conditions

Sarcoidosis, Pulmonary

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Sarcoidosis; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: February 1, 1999
• Study Completion: May 1, 2004
• Last Updated: March 4, 2008

Record last verified: 2004-05

Locations

US (1)