Treatment of Pulmonary Sarcoidosis With Pentoxifylline

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00001877
• Date of registration: 03/11/1999
• Prospective Registration: No
• Primary sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Public title: Treatment of Pulmonary Sarcoidosis With Pentoxifylline
• Scientific title: Treatment of Pulmonary Sarcoidosis With Pentoxifylline
• Date of first enrolment: February 1999
• Target sample size: 100
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00001877
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Pulmonary Sarcoidosis

Intervention(s)

Drug: Pentoxifylline

Secondary ID(s)

99-H-0057

990057

Source(s) of Monetary Support

Please refer to primary and secondary sponsors