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Sponsors and Collaborators: |
Medical University of South Carolina Hoffmann-La Roche |
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Information provided by: | Medical University of South Carolina |
ClinicalTrials.gov Identifier: | NCT00262132 |
Corticosteroids are presently the drug of choice for the treatment of pulmonary sarcoidosis. However, corticosteroids are associated with many significant side effects. For this reason, it would be beneficial to find an alternative agent to corticosteroids for the treatment of pulmonary sarcoidosis. This study is an open label trial of mycophenolate for new onset pulmonary sarcoidosis. Patients are candidates for this study if they have biopsy proven pulmonary sarcoidosis and a vital capacity or FEV1 less than 80% of predicted. Patients must undergo bronchoscopy where not only is the diagnosis of pulmonary sarcoidosis required, but in addition, cells are obtained from bronchoalveolar lavage. If the patients are diagnosed with pulmonary sarcoidosis, they are placed on an initial dose of 500mg BID of mycophenolate for 1 week. If their blood counts are not affected on this dose and they have no significant symptoms that are thought to be drug related, then their dose is escalated to 1g BID for the remaining 9 weeks of the study (the total study drug therapy time is 10 weeks). The patients are followed with multiple study visits. At these visits blood tests are drawn to make sure that there are no significant side effects from mycophenolate. In addition, the patients have a history and physical performed to evaluate the clinical state of their sarcoidosis and to detect mycophenolate side effects. On completion of 10 weeks of mycophenolate therapy, the patients undergo a second bronchoscopy with bronchoalveolar lavage to obtain cells for analysis. The patients are evaluated with spirometry, measurements of shortness of breath (dyspnea), and a quality of life scale (SF36) at serial visits during their study. The primary endpoint of the study is improved, unchanged or worse FVC. It is hoped that this pilot study will suggest that mycophenolate is a reasonable treatment option for new onset pulmonary sarcoidosis.
Condition | Intervention | Phase |
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Pulmonary Sarcoidosis |
Drug: Mycophenolate |
Phase III |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | Mycophenolate for Pulmonary Sarcoidosis |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
New acute pulmonary sarcoidosis defined as a FVC or FEV1 less than 80 percent of predicted plus symptoms of worsening dyspnea, cough, chest pain, or wheezing in patients without a prior history of pulmonary sarcoidosis. All such patients will also require bronchoscopy with transbronchial biopsy that demonstrates noncaseating granulomas of unknown cause. Such patients are usually treated for acute pulmonary sarcoidosis. The transbronchial biopsy specimens must have negative stains for mycobacteria and fungi.
> 18 years of age
Signing a written informed consent form.
Exclusion Criteria
United States, South Carolina | |
Medical University of South Carolina | |
Charleston, South Carolina, United States, 29425 |
Principal Investigator: | Marc A Judson, MD | Medical University of South Carolina |
Study ID Numbers: | CEL401, HR 11031 |
Study First Received: | December 5, 2005 |
Last Updated: | January 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00262132 |
Health Authority: | United States: Food and Drug Administration |
Lymphatic Diseases Lung Diseases, Interstitial Sarcoidosis, pulmonary Respiratory Tract Diseases Lung Diseases |
Mycophenolate mofetil Sarcoidosis Lymphoproliferative Disorders Sarcoidosis, Pulmonary |
Immunologic Factors Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |