FSR - Find a Trial - Clinical Trials

The National Institutes of Health has developed an on-line searchable database that contains current information on clinical research studies. Research studies typically provide free care to those who participate. A summary of these trials is listed below. CLICK HERE or visit www.clinicaltrials.gov and search 'sarcoidosis' to find additional information on current clinical trials.

Studies at the National Institutes of Health (NIH) in Bethesda, Maryland are free of charge to those who are eligible to participate and willing to receive treatment at the center. In some cases, travel expenses are reimbursed.

US Locations Click for International	Trial Descriptions as of Winter 2011
National Institutes of Health Clinical Center Bethesda, Maryland	Atorvastatin to Treat Pulmonary Sarcoidosis This study will determine if atorvastatin (Lipitor), a widely used cholesterol-lowering drug, can help patients with pulmonary (lung) sarcoidosis and replace or reduce the need for patients to take steroids, such as prednisone. Many sarcoidosis patients are treated with prednisone, but the drug is not effective in all patients, and it can cause serious side effects, such as high blood pressure, sugar diabetes, eye cataracts, and bone thinning. Patients with stage II or III pulmonary sarcoidosis between 18 and 70 years of age who require prednisone may be eligible for this study. Participants are randomly assigned to one of two treatment groups: one group takes atorvastatin; the other takes a placebo (a look-alike pill that has no active ingredient to fight sarcoidosis). Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov Please refer to this study by its ClinicalTrials.gov identifier: NCT00279708
Multiple Locations Alabama, Colorado, Ohio, Pennsylvania, South Carolina	Safety of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Adults With Stage II or III Pulmonary The primary objective of the study is to assess the safety and tolerability of two different doses of PDA001 in subjects with Stage II or III Pulmonary Sarcoidosis (PS) who are refractory to one or more of the following treatments for PS: methotrexate, immunosuppressants or cytotoxic agents. Contact: Georgia Brockway 732-564-3570 gbrockway@celgene.com Please refer to this study by its ClinicalTrials.gov identifier: NCT01440192
Multiple locations	A Study to Evaluate the Safety and Effectiveness of Ustekinumab or Golimumab Administered Subcutaneously (SC) in Patients With Sarcoidosis This study tests the safety and effectiveness of ustekinumab or golimumab compared to placebo (placebo looks like the drugs being studied, but has no active ingredients). The purpose of this research study is to determine if ustekinumab or golimumab is safe and to determine its effects (good and bad) on patients with sarcoidosis. The study will be conducted at approximately 40 sites globally. Patients can remain on usual, accepted treatment for sarcoid while enrolled in the study. To learn how to participate, click here. If you still have questions: JNJ.CT@sylogent.com Please refer to this study by its ClinicalTrials.gov identifier: NCT00955279
University of North Carolina at Chapel Hill Chapel Hill, North Carolina	Tadalafil for Sarcoidosis Associated Pulmonary Hypertension (SAPH) This study is designed to assess the efficacy and safety of tadalafil in patients with Sarcoidosis Associated Pulmonary Hypertension. Contact: Hubert J Ford, MD 919-966-2531 hjford@med.unc.edu Contact: Sharikia J Burt, MS 919-966-2531 sburt99@med.unc.edu Please refer to this study by its ClinicalTrials.gov identifier: NCT01324999
Virginia Clinical Research, Inc. Norfolk, VA	A Study of Adalimumab to Treat Sarcoidosis of the Skin The purpose of this study is to determine if adalimumab is an effective for the skin manifestations of sarcoidosis. Contact: Robert J Pariser, MD 757-622-6315 rpariser@gmail.com Please refer to this study by its ClinicalTrials.gov identifier: NCT00274352
University of Cincinnati Cincinnati, Ohio The Cleveland Clinic Cleveland, Ohio	Registry of Sarcoidosis Associated Pulmonary Hypertension (RESAPH) This is a multi center registry of sarcoidosis associated pulmonary hypertension (SAPH). With this registry, the investigators will characterize the demographics, clinical course, hemodynamics, pulmonary physiology, and disease management of sarcoidosis associated pulmonary hypertension on the United States. The investigators will also compare these features to non-US sites. Contact: Rebecca Ingledue 513-584-6252 ingledra@ucmail.uc.edu Please refer to this study by its ClinicalTrials.gov identifier: NCT01467791
Northwestern University Chicago, IL	Hematopoietic Stem Cell Support in Patients With Refractory Sarcoidosis This study is designed to examine whether treating patients with high dose cyclophosphamide (a drug which reduces the function of the immune system) and ATG (a protein that kills the immune cells that are thought to be causing this disease), followed by return of the previously collected blood stem cells will stop the progression of sarcoidosis. Stem cells are undeveloped cells that have the capacity to grow into mature blood cells, which normally circulate in the blood stream. The purpose of the high dose cyclophosphamide and ATG is to destroy the cells in the immune system. The purpose of the stem cell infusion is to evaluate whether this treatment will produce a normal immune system that will no longer attack the body. Contact: Dzemila Spahovic, MD 312-908-0059 d-spahovic@northwestern.edu Please refer to this study by its ClinicalTrials.gov identifier: NCT00282438
University of Chicago Chicago, IL	A Study of the Natural Progression of Interstitial Lung Disease (ILD) The purpose of this study is to obtain information on all patients being cared for by the ILD program in an effort to better understand the natural course of these diseases. Hopefully getting this information will lead to a better understanding of how these diseases behave with time. This in turn, will let physicians' better treat patients in the future. Another goal of the study is to be able to see if in the future a patients' genetics can be linked to the type of disease they have and the way it behaves. We do not yet know what that may be. Our goal is to study this in aggregate rather than in any individual patients. Which genes to study are also unclear. But the only hope of having a clearly defined group to match the genetics to in the future requires that we obtain samples now in conjunction with collecting the data on the disease progression. Contact: Spring Maleckar 773-834-5864 Please refer to this study by its ClinicalTrials.gov identifier: NCT00470327
University of North Carolina, Chapel Hill Chapel Hill, North Carolina Duke University Durham, North Carolina	Phase 2 Study of Ex-vivo Perfusion and Ventilation of Lungs to Assess Transplant Suitability The purpose of this research study is to learn about the safety of transplanting lungs that have been ventilated (attached to a breathing machine or ventilator to deliver oxygen) and perfused with a lung perfusion solution (Steen solution™, made by Vitrolife). This ventilation and perfusion will be done outside the body (ex-vivo) in a modified cardiopulmonary bypass circuit (the kind of device used routinely during most heart surgeries). The purpose of performing ex-vivo perfusion and ventilation is to learn how well the lungs work, and whether they are likely safe to transplant. Contact: Will Simmons, MS, CCRP 919-966-3381 simmonsw@med.unc.edu Please refer to this study by its ClinicalTrials.gov identifier: NCT01241942
National Institutes of Health Bethesda, MD Kobe Medical Center Kobe, Japan	Role of Helicobacter Pylori and Its Toxins in Lung and Digestive System Diseases This study will examine bacteria and toxins in the mouth, lung and digestive system that may be the cause of various diseases or symptoms. H. pylori is a bacterium that produces various toxins that may contribute to lung problems. This study will examine specimens collected from the mouth, teeth, lung, digestive tract and blood to measure H. pylori and its toxins and their effects on cells. People 18 years of age and older with or without gastrointestinal disease may be eligible for this study. These include people without a history of lung disease as well as patients with any of the following: lymphangioleiomyomatosis, asthma, sarcoidosis, other chronic or genetic lung disease (e.g., chronic obstructive pulmonary disease, cystic fibrosis or eosinophilic granuloma). Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov Contact: TTY 1-866-411-1010 Please refer to this study by its ClinicalTrials.gov identifier: NCT00366509
National Institutes of Health Bethesda, Maryland	Role of Genetic Factors in the Development of Lung Disease This study is designed to evaluate the genetics involved in the development of lung disease by surveying genes involved in the process of breathing and examining the genes in lung cells of patients with lung disease. The study will focus on defining the distribution of abnormal genes responsible for processes directly involved in different diseases affecting the lungs of patients and healthy volunteers. Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov Contact: TTY 1-866-411-1010 Please refer to this study by its ClinicalTrials.gov identifier: NCT00001532
International Sites	Trial Descriptions as of Winter 2011
Kurume University Kurume, Japan	Sarcoidosis With Cardiac Involvement and FDG-PET Sarcoidosis is a multi-systemic inflammatory disorder of unknown cause characterized by the formation of non-caseating granulomas in involved organs. Its cardiac involvement may be potentially fatal. Although endomyocardial biopsy is required for deﬁnitive diagnosis of cardiac sarcoidosis, it is invasive and lacks sensitivity. The specific diagnostic tool for cardiac sarcoidosis is far from satisfactory. Recent studies have revealed that FDG-PET with under fasting conditions is a useful method for identiﬁcation of cardiac sarcoidosis patients. However, to our knowledge, no investigations have been published with regard to FDG quantification for the diagnosis and management of cardiac sarcoidosis by PET. Contact: Nobuhiro Tahara, MD, PhD +81-942-31-7580 ntahara@med.kurume-u.ac.jp Please refer to this study by its ClinicalTrials.gov identifier: NCT00958087
Maastricht University Medical Center Maastricht, Netherlands	Role of Proteomics in Diagnosing Sarcoidosis Sarcoidosis is generally diagnosed by using general clinical methods to evaluate the status of the lung including a chest X-ray, lung biopsy and bronchoalveolar lavage (BAL). However, some of these methods are considered to be rather invasive and, even more important, non-conclusive. Therefore, the current study has been designed to evaluate the use of a new technique, called SELDI-TOF mass spectrophotometry, for the diagnosis of sarcoidosis. This technique enables the analysis of all enzymes present in the blood of sarcoidosis patients which may hopefully lead to creating a disease-specific protein-profile that may facilitate the recognition of sarcoidosis. Moreover, these results will be compared with other currently used laboratory parameters. Marjolein Drent, Professor 0031-43-3874347 m.drent@mumc.nl Please refer to this study by its ClinicalTrials.gov identifier: NCT00626938
Leiden University Medical Center - Multiple locations Belgium, Denmark, Germany, Netherlands, Poland, United Kingdom	Trial for the Diagnosis of Sarcoidosis (GRANULOMA) This randomized study investigates two different diagnostic strategies for patients with suspected pulmonary sarcoidosis stage I/II. The objective is to assess the role of endosonography (EBUS/ EUS - FNA) in demonstrating non-caseating granulomas in comparison with conventional bronchoscopy (TBLB + EBB). Also the researchers investigate the additional value of BAL, in relation to endosonography and conventional bronchoscopy (TBLB + EBB), in diagnosing sarcoidosis. Thirdly the researchers aim to assess the rate of complications in both the endosonography and conventional bronchoscopic workup. Contact: J T Annema, M.D. PhD 0715262950 ext 0031 j.t.annema@lumc.nl Contact: M B von Bartheld, MSc 0715263261 ext 0031 m.b.von_bartheld@lumc.nl Please refer to this study by its ClinicalTrials.gov identifier: NCT00872612
Postgraduate Institute of Medical Education and Research Chandigarh, India	Efficacy of Antituberculous Therapy in Management of Sarcoidosis From the time sarcoidosis has been described, there has always been a belief that the disease is in some way related to tuberculosis. If indeed tuberculosis is a causal factor in sarcoidosis, then the hypothesis can be further reinforced, if anti-tubercular therapy (ATT) is useful in treatment of sarcoidosis. Very few trials have been conducted in the past but the results of these trials have been discouraging. These trials were generally small studies and limited by time bias and used older regimens based on isoniazid, amino-salicylic acid and streptomycin. In our experience nearly one third of patients who are finally diagnosed to have sarcoidosis, have received ATT for variable length of time, but its impact of final outcome of sarcoidosis has not been studied. The aim of this prospective randomized controlled trial (RCT) is to evaluate the efficacy and safety of Rifampicin and Isoniazid along with prednisolone compared to prednisolone alone in treatment of Sarcoidosis. Contact: Dheeraj Gupta, MD, DM +911722756823 dheeraj@indiachest.org Please refer to this study by its ClinicalTrials.gov identifier: NCT01245036
Royal Brompton Hospital London, United Kingdom Heidelberg, Germany	Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) Versus Endobronchial Ultrasound Transbronchial Needle Biopsy (EBUS-TBNB) A prospective diagnostic clinical study randomising patients undergoing endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) of enlarged mediastinal and hilar lymph nodes to have sampling using the usual EBUS-TBNA needle or a novel biopsy forceps (EBUS-TBNB). The study aims to establish whether the use of EBUS-TBNB can significantly increase the diagnostic yield over EBUS-TBNA, without an increase in complication rates. Contact: Zaid Zoumot, MBBS, MRCP, MSc +442073518029 zzoumot@doctors.org.uk Contact: Pallav L Shah, MD FRCP +442073518021 pallav.shah@imperial.ac.uk Please refer to this study by its ClinicalTrials.gov identifier: NCT01467635
Lung Clinic Hemer Hemer, Germany	Breath Analysis by Ion Mobility Spectrometry Recognition of disease specific clusters of volatile organic compounds in patients with different lung diseases, using breath analysis with ion mobility spectrometry. This study hypothesizes that breath analysis with ion mobility spectrometry can differentiate pulmonary disorders. Lung diseases of interest are: • COPD • tumors • airway infection • interstitial lung disease • sleep apnea Contact: Michael Westhoff, MD 004923729082203 michael.westhoff@lkhemer.de Contact: Patric Litterst, MD 004923729082545 pneumologie@lkhemer.de Please refer to this study by its ClinicalTrials.gov identifier: NCT00632307
Hôpital Avicenne - Service de Médecine Interne Bobigny France CHU Michallon de Grenoble Grenoble France	Efficacy Study of Methotrexate to Treat Sarcoid-associated Uveitis (UVEXATE) The purpose of this study is to determine whether methotrexate is a effective corticosteroid sparing agent in the treatment of sarcoid-associated uveitis. Contact: Sébastien ABAD, MD 01-48-95-53-52 sebastien.abad@avc.aphp.fr Please refer to this study by its ClinicalTrials.gov identifier: NCT00918554

Web Sites::
In addition to the trials listed above, CLICK HERE or visit www.clinicaltrials.govand search 'sarcoidosis' to find additional information on current clinical trials. If you conduct a ‘Focused Search’, you can learn about those studies on sarcoidosis within your geographical area.

Sarcoidosis clinical trials at the clinical center of the National Institutes of Health (NIH) in Bethesda, Maryland are free of charge to those who are eligible to participate and willing to receive treatment at the center. For more information on these studies, see the NIH clinical center Web site at: www.cc.nih.gov.

The National Heart, Lung, and Blood Institute (NHLBI) also maintains a database of current trials. Visit their Patient Recruitment Site for more information.