结节病的转化研究-猫眼课题宝

结节病的转化研究

批准号：

7734980

负责人：

VINCENT MANGANIELLO

金额：

$18.24万

依托单位：

NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

依托单位国家：

美国

项目类别：

财政年份：

资助国家：

美国

项目状态：

未结题

起止时间：

至

来源：

https://reporter.nih.gov/project-details/7734980

关键词：

Acute Adrenal Cortex Hormones Affect African American Age Alveolitis Anti-Inflammatory Agents Anti-inflammatory Biological Markers Carbon Monoxide Cardiac Categories Cause of Death Cells Characteristics Chest Chronic Cicatrix Clinical Clinical Course of Disease Clinical Protocols Clinical Trials Design Clostridium perfringens epsilon toxin Data Deterioration Diabetes Mellitus Disease Disease remission Disruption Dose Dyspnea End Point Enrollment Etiology Exhalation Fatigue Fibrosis Functional disorder Gold Granuloma Granulomatous Helper-Inducer T-Lymphocyte Hypertension Image Incidence Individual Inflammation Inflammatory Inflammatory Response Interferon Type II Interleukin-12 Interstitial Pneumonia Interview Liquid substance Lung Mediating Mediator of activation protein Monitor Mononuclear Morbidity - disease rate Muscle Weakness Nitric Oxide Organ Osteoporosis Outcome Measure Pathogenesis Pathway interactions Patients Pharmaceutical Preparations Physiological Plasma Prednisone Production Protocols documentation Pulmonary Fibrosis Pulmonary Sarcoidosis Quality of life Quality-of-Life Assessment Questionnaires Race Randomized Rate Relapse Reporting Research Ethics Committees Resolution Respiratory Muscles Respiratory physiology SF-36 Sampling Sarcoidosis Screening procedure Secondary to Serum Staging Standards of Weights and Measures Steroids Structure T-Lymphocyte Telephone Testing Therapeutic Agents Therapeutic Effect atorvastatin chemokine concept cytokine double-blind placebo controlled trial experience human tissue inhibitor/antagonist macrophage monocyte novel phosphoric diester hydrolase preclinical study response sex translational study young adult

中文摘要

翻译

临床方案（NHLBI 06-H-0072）：阿托伐他汀作为II期和III期肺结节病的疾病调节剂：一项随机、双盲、安慰剂对照试验。

英文摘要

Clinical Protocol (NHLBI 06-H-0072): Atorvastatin as a disease-modifying agent in Stage II and Stage III Pulmonary Sarcoidosis: A randomized, double-blinded, placebo-controlled trial. Objectives: The objective of this protocol is to conduct, in patients with pulmonary sarcoidosis who require prednisone treatment, a randomized, double-blind placebo-controlled, trial which aims to determine, as prednisone dose is tapered, if atorvastatin administration results in less steroid use and longer steroid-free intervals. The primary endpoint is the duration of the steroid-sparing period. Secondary clinical and physiological endpoints are intended to analyze possible anti-inflammatory and beneficial effects of the drugs. Since there is no gold standard outcome measure in sarcoidosis, four categories of secondary endpoints will be used to characterize the effects of the therapeutic agent on the clinical course of the disease: imaging (high resolution chest CT); quality of life assessments (SF-36 and SGRQ), anti-inflammatory effects (biomarkers and relapse rates), and functional effects (CPET, PFTs). Finally, we will study the utility of exhaled nitric oxide and carbon monoxide in monitoring disease activity. Progress achieved: To date, over 544 subjects have been contacted, and approximately 500 have been interviewed using an IRB-approved screening questionnaire. Approximately 30 patients were eligible for further screening. Twenty four subjects have been enrolled, randomized, and started on study agent. Recruitment Data: Recruitment Parameters (n, subjects) Subject Contacts (544) Telephone Screening Questionnaires (500) Clinical Exams/Screens Completed (91) Accepted (27) Enrolled (24) Subjects Eligible for Further Screening (30) Human Tissues (Fluids) Samples 2008 Total Blood (serum/plasma) 29 101 BAL 8 11

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