Risk Indicators of Sarcoidosis Evolution-Unified Protocol
SarcoidosisPulmonaryThe purpose of this study is to develop prediction models that can prognosticate patients with sarcoidosis using clinical data and blood markers that can be obtained during a clinic visit.
Safety and Efficacy Study of Bosentan in Progressive Pulmonary Sarcoidosis
SarcoidosisPulmonary HypertensionProgressive pulmonary sarcoidosis occurs in up to twenty percent of patients who require persistent treatment, but available treatment options have shown considerable long-term toxicity and uncertain or unproven efficacy. In these patients, pulmonary fibrosis and pulmonary hypertension are common complications which have major prognostic impact. Endothelin-1 (ET-1) has been demonstrated to play a key role in pulmonary fibrosis and pulmonary hypertension, and a potential role in pulmonary sarcoidosis. ET-1 is a potent vasoconstrictor and can promote fibrosis, cell proliferation, and remodeling, and is pro-inflammatory. Preliminary data have shown the therapeutic potential of the endothelin receptor antagonist (ERA) bosentan in sarcoidosis associated pulmonary hypertension. In this light, the therapeutic potential of bosentan as an add-on treatment in progressive pulmonary sarcoidosis needs to be evaluated.
Safety of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Adults...
Stage 2 Pulmonary SarcoidosisStage 3 Pulmonary SarcoidosisThe primary objective of the study is to assess the safety and tolerability of a single dose of PDA001 (given twice) 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.
A Dose Escalation Study to Assess the Safety and Efficacy of Pulsed Inhaled Nitric Oxide in Subjects...
Pulmonary HypertensionPulmonary Fibrosis2 moreA phase 2b, open label study to assess the safety and efficacy of increasing doses of pulsed, inhaled nitric oxide (iNO) in subjects with pulmonary fibrosis and sarcoidosis on long term oxygen therapy followed by a long term extension study
Study of Intravenous ATYR1923 (Efzofitimod) for Pulmonary Sarcoidosis
Pulmonary SarcoidosisThis randomized, double-blind, placebo matched to efzofitimod-controlled, study will evaluate the safety, tolerability, immunogenicity, pharmacokinetic (PK), and preliminary efficacy of multiple ascending doses of IV efzofitimod in participants with pulmonary sarcoidosis undergoing a protocol-guided oral corticosteroid (OCS) tapering regimen.This study will consist of 3 staggered multiple dose cohorts. Each eligible participant will participate in only one cohort during the study. Within each cohort, 12 participants will be randomized 2:1 to efzofitimod (N=8) or placebo matched to efzofitimod (N=4).
Tofacitinib Hypothesis-generating, Pilot Study for Corticosteroid-Dependent Sarcoidosis
SarcoidosisPulmonary2 moreThis is a pilot study to determine whether further research is warranted to assess whether tofacitinib is an effective steroid sparing treatment for pulmonary sarcoidosis. The primary endpoint for this study is a 50% or greater reduction in corticosteroid requirement.
Phase II Investigation of Antimycobacterial Therapy on Progressive, Pulmonary Sarcoidosis
Sarcoidosis; Antimycobacterial TherapyThe primary purpose of this study is to investigate the efficacy and safety of oral antimycobacterial therapy in patients with confirmed progressive pulmonary sarcoidosis. We suspect that the CLEAR regimen will improve the absolute FVC percent predicted in chronic pulmonary sarcoidosis participants.
Atorvastatin to Treat Pulmonary Sarcoidosis
SarcoidosisPulmonaryThis study will determine if atorvastatin (Lipitor) can help patients with pulmonary (lung) sarcoidosis and replace or reduce the need for patients to take steroids, such as prednisone. Sarcoidosis is an inflammatory disease that can affect nearly any part of the body. Pulmonary sarcoidosis may resolve on its own or it may progress to irreversible lung damage, disability, and death. 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. Candidates are screened with the tests and procedures described below. 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). Both groups take the pills by mouth once a day for 12 months. When treatment begins, participants begin to have their prednisone dosage tapered (reduced). The tapering is done over 8 weeks until the dose is reduced by 90 percent. Patients are evaluated periodically to determine if the two groups differ in how long they can remain on the reduced dose of prednisone without having their symptoms recur, requiring an increase in the prednisone dose. A full battery of tests is done at the initial screening visit and at the 26- and 52-week follow-up visits, requiring hospitalization for 3-5 days. Additional interim outpatient assessments are done at 6, 12, 18 and 36 weeks. The full battery of tests at the initial screening and the 26- and 52-week visits includes the following: Medical history, physical examination, blood and urine tests, assessment of disease severity and activity. Questionnaires. Chest x-ray (CXR) and computed tomography (CT) scan. Abdominal ultrasound. Six-minute walk test (6MWT) Exercise testing and blood gases Pulmonary function tests (PFT) Maximum incremental ventilatory performance test (MIVP) Exhaled nitric oxide and carbon monoxide (Exhaled NO and CO) Bronchoscopy and lavage Interim testing at 6, 12, 18 and 36 weeks includes PFT, MIVP, Exhaled NO and CO, CXR, questionnaire, blood tests, and 6MWT. Six months after completing the study, participants fill out a questionnaire.
Azithromycin a Treatment for Pulmonary Sarcoidosis
SarcoidosisPulmonaryPatients with sarcoidosis need treatment options that effectively control their disease without causing undesirable side effects. An appealing strategy is to repurpose existing drugs which possess beneficial immune modulating activity and are safe for long-term use. Recently, increased activity of the mTOR intracellular signalling pathway in inflammatory cells has emerged as a key driver of granulomatous inflammation in mouse models and patients with sarcoidosis. The macrolide antibiotic azithromycin directly inhibits mTOR activity in inflammatory cells, making it a prime target for drug repurposing in sarcoidosis. Azithromycin has an acceptable tolerability profile when used for long-term treatment of other chronic respiratory disease Single centre open label clinical trial of oral azithromycin 250 mg once daily for 3 months in 20-30 patients with pulmonary sarcoidosis. The Investigator have opted for an open label study because this will be the first study of azithromycin in sarcoidosis. Trial assessments will be performed according to standards of Good Clinical Practice with assessments at baseline, 1, and 3 months. All other clinical care, investigations, and treatment (if indicated) will remain the responsibility of the treating physician and based on clinical MDT consensus decisions.
Nicotine Treatment for Pulmonary Sarcoidosis: A Clinical Trial Pilot Study
SarcoidosisThe purpose of this study is to determine if nicotine treatment is beneficial for the treatment of sarcoidosis. Sarcoidosis is a disease of unknown cause that leads to inflammation. This disease affects your body's organs.