Study of Asthma and Nasal Steroids (STAN)

哮喘和鼻类固醇研究 (STAN)

基本信息

批准号：
7647036
负责人：
Robert A. Wise
金额：
$ 40.97万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
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/7647036
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 Clinical Clinical Research Clinical Trials Communication 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 Juniper Lead Link Lung Manuals Masks Measures Monitor Morbidity - disease rate Nose Nose Diseases Online Systems Operative Surgical Procedures 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 Ethics Committees 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 follow-up health care service utilization health related quality of life improved meetings primary outcome programs prototype pulmonary function randomized placebo controlled trial response rhinosinusitis secondary outcome symposium tool treatment effect web site

项目摘要

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）：这是重新提交哮喘和鼻类固醇研究铅临床中心的申请；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有关。在美国，哮喘是一个重大的公共卫生问题，哮喘控制差与大量发病率和医疗保健利用有关。可能导致哮喘控制不佳的重要因素是鼻子和鼻窦疾病。美国肺协会 - 雅典 - 疾病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完成的试验的结果已确定鼻炎和鼻窦炎是影响哮喘症状和控制的合并症的重要原因。拟议的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对哮喘的控制。尽管慢性鼻炎和鼻窦炎与哮喘控制不良和医疗保健利用率增加有关，但尚不清楚治疗这些疾病对哮喘控制的影响。我们提出了一个六个月的随机，双盲，安慰剂对照试验，招募了380名参与者，控制哮喘和慢性鼻炎/鼻窦炎。我们将使用我们开发的敏感和特定的工具来鉴定患有哮喘患者的慢性鼻炎和鼻窦炎。除常规哮喘治疗外，参与者还将随机接受鼻类固醇或匹配的安慰剂。该试验的主要目的是评估用鼻类固醇增加治疗是否可以改善哮喘的控制。我们将对所有参与者进行过敏的皮肤测试，并在所有中心保持花粉计数的记录，以确定过敏是否是参与者鼻固醇反应的重要因素。 ALA-ACRC网络的独特位置是确定哮喘治疗慢性鼻炎和鼻窦炎的作用。当前提案的结果将为控制哮喘控制良好的患者提供重要的新数据来指导治疗。哮喘是美国的主要公共卫生问题。鼻炎和鼻窦炎可能导致哮喘恶化。当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良好的患者的治疗。