Study of Asthma and Nasal Steroids (STAN)

哮喘和鼻类固醇研究 (STAN)

• 批准号: 8090379
• 负责人: Robert A. Wise
• 金额: $ 40.99万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8090379
• 关键词: 18 year old; 6 year old; Adherence; Adrenal Cortex Hormones; Adult; Adverse event; Affect; Age; American Lung Association; Asthma; Breathing; Child; Chronic Rhinitis; Chronic Sinusitis; Clinical; Clinical Research; Clinical Trials; Communication; Comorbidity; Consent; Consent Forms; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Quality; Disease; Documentation; Electronics; Enrollment; Ensure; Epidemiology; Equipment and supply inventories; Health Services Accessibility; Healthcare; Hypersensitivity; Hypersensitivity skin testing; Individual; Inflammation; Information Systems; Institutional Review Boards; Juniper; Lead; Link; Lung; Manuals; Masks; Measures; Monitor; Morbidity - disease rate; Nose; Nose Diseases; Online Systems; Outcome Measure; Participant; Patients; Performance; Pharmaceutical Preparations; Placebos; Pollen; Positioning Attribute; Process; Protocols documentation; Public Health; Public Health Schools; Publishing; Randomized; Recording of previous events; Reporting; Research; Research Infrastructure; Research Personnel; Rhinitis; Sampling; Scheme; Secure; Shipping; Ships; Sinus; Sinusitis; Source; Steroids; Symptoms; System; Testing; Time; Training; United States; United States National Institutes of Health; Vermont; Visit; Work; clinical research site; computerized; data management; data quality/integrity; design; distributed data; double-blind placebo controlled trial; health care service utilization; health related quality of life; improved; meetings; operation; primary outcome; programs; prototype; pulmonary function; randomized placebo controlled trial; response; rhinosinusitis; secondary outcome; symposium; tool; treatment effect; web site

DESCRIPTION (provided by applicant): This is the resubmission of an application for the Lead Clinical Center for the Study of Asthma and Nasal Steroids; it is linked to the Data Coordinating Center application submitted by Dr. Robert Wise from the Johns Hopkins Bloomberg School of Public Health. Asthma is a significant public health problem in the United States and poor asthma control is associated with significant morbidity and health care utilization. An important factor that may contribute to poor asthma control is disease of the nose and sinuses. The American Lung Association-Asthma Clinical Research Centers is a network of 20 academic research centers. Results from trials completed by ALA-ACRC have identified rhinitis and sinusitis as a significant cause of co-morbidity that affects asthma symptoms and control. The objective of the proposed clinical trial is to determine if treatment of chronic rhinitis and sinusitis will improve control of asthma. Although chronic rhinitis and sinusitis have been associated with poor asthma control and increased health care utilization, the effect of treating these diseases on asthma control is not known. We propose a six-month randomized, double-blinded, placebo-controlled trial enrolling 380 participants with poorly controlled asthma and chronic rhinitis/sinusitis. We will use a sensitive and specific tool, developed by us, to identify chronic rhinitis and sinusitis in people with asthma. Participants will be randomized to receive nasal steroid or matching placebo in addition to their regular asthma treatments. The primary objective of the trial will be to evaluate whether the addition of treatment with nasal steroids improves asthma control. We will perform allergy skin testing on all participants, and keep a record of pollen counts at all centers, to determine if allergy is an important factor in the response to nasal steroid in participants. The ALA-ACRC network is uniquely positioned to determine the effect of treating chronic rhinitis and sinusitis in asthma; results of the current proposal will provide significant new data to guide therapy in patients with poorly controlled asthma. Asthma is a major public health problem in the United States. Rhinitis and sinusitis may lead to worsening of asthma. The aim of the current proposal is to determine if treatment of rhinitis and sinusitis will improve asthma control - results of this study will guide therapy in patients with poorly controlled asthma.

描述（由申请人提供）：这是哮喘和鼻用类固醇研究的主要临床中心申请的重新提交;它与约翰霍普金斯彭博公共卫生学院的Robert Wise博士提交的数据协调中心申请相关联。在美国，哮喘是一个重要的公共卫生问题，哮喘控制不佳与严重的发病率和卫生保健利用有关。可能导致哮喘控制不佳的一个重要因素是鼻子和鼻窦疾病。美国肺脏协会哮喘临床研究中心是一个由20个学术研究中心组成的网络。ALA-ACRC完成的试验结果已经确定鼻炎和鼻窦炎是影响哮喘症状和控制的共病的重要原因。临床试验的目的是确定慢性鼻炎和鼻窦炎的治疗是否会改善哮喘的控制。尽管慢性鼻炎和鼻窦炎与哮喘控制不良和医疗保健利用增加有关，但治疗这些疾病对哮喘控制的影响尚不清楚。我们提出了一项为期6个月的随机、双盲、安慰剂对照试验，招募了380名哮喘和慢性鼻炎/鼻窦炎控制不佳的参与者。我们将使用我们开发的一种敏感而特异的工具来识别哮喘患者的慢性鼻炎和鼻窦炎。受试者将被随机分配接受鼻用类固醇或匹配的安慰剂，除了他们的常规哮喘治疗。该试验的主要目的是评估鼻用类固醇治疗是否能改善哮喘控制。我们将对所有参与者进行过敏皮肤测试，并在所有中心记录花粉计数，以确定过敏是否是参与者对鼻用类固醇反应的重要因素。ALA-ACRC网络在确定治疗慢性鼻炎和鼻窦炎对哮喘的影响方面具有独特的地位;当前提案的结果将提供重要的新数据，以指导控制不良的哮喘患者的治疗。哮喘是美国的一个主要公共卫生问题。鼻炎和鼻窦炎可能导致哮喘恶化。目前建议的目的是确定鼻炎和鼻窦炎的治疗是否会改善哮喘控制-这项研究的结果将指导哮喘控制不良患者的治疗。