Clinical trial: Treatment of Pulmonary Sarcoidosis With Pentoxifylline (NCT00001877)

Eligibility 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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.



Patient description (medical language): A 39-year-old woman comes to the clinic complaining of arthralgias and nodules on her legs.  She has no fever or other skin rashes. The prior medical condition is unremarkable, and she takes no medications.  On physical examination, there is moderate hepatomegaly. The lesions on her legs are tender and present predominantly on the anterior surface of the lower extremities. She doesn't smoke and drinks alcohol occasionally. The patient has 2 male sexual partners. Vital signs are normal. Chest x-ray demonstrates enlarged hilar lymph nodes, and laboratory testing reveals an elevated ACE level. Biopsy of the skin lesion shows noncaseating granulomas that stain negative for fungi & acid-fast bacilli.

Patient description (patient's own words): I'm just a 39-year-old young woman but lately I have noticed some underlying cysts on my legs and my joints were hurting so much. I don't have a fever. I don't have rashes. My medical history is totally clean and I don't take any medication. When I went to the clinic they did a physical examination where they found that my liver is enlarged. They also found that the lesions on my legs are kind of tender and they are located on the front side of my legs. I do not smoke and I drink alcohol occasionally. I have to male sexual partners. On the day of my visit my vitals were fine. I did an X-ray of my chest and I had swollen lymph nodes. I also has a blood test and it came back with a high ACE level. I also had a biopsy of my skin lesions that came back negative for fungi and AFB.

Does the patient match the trial criteria? 1