Study of Asthma and Nasal Steroids (STAN)

描述(由申请人提供)：这是重新提交的哮喘和鼻腔类固醇研究领导临床中心的申请；它与约翰霍普金斯大学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，哮喘是一个重要的公共卫生问题，哮喘控制不佳与显著的发病率和医疗保健利用率有关。导致哮喘控制不佳的一个重要因素是鼻腔和鼻窦疾病。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完成的试验结果表明，鼻炎和鼻窦炎是影响哮喘症状和控制的共同发病的重要原因。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哮喘的控制。虽然慢性鼻炎和鼻窦炎与哮喘控制不佳和医疗保健利用率增加有关，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，纳入了380名哮喘和慢性鼻炎/鼻窦炎控制不良的参与者。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。参与者将随机接受鼻腔类固醇或匹配的安慰剂，除了他们的常规哮喘治疗。该试验的主要目标将是评估鼻腔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，并记录所有中心的花粉计数，以确定过敏是否是参与者对鼻腔类固醇反应的重要因素。ALA-ACRC网络在确定治疗哮喘的慢性鼻炎和鼻窦炎的效果方面具有独特的地位；当前建议的结果将为指导控制不佳的哮喘患者的治疗提供重要的新数据。哮喘是美国的一个主要公共卫生问题。鼻炎和鼻窦炎可能会导致哮喘恶化。目前这项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控制不佳的哮喘患者的治疗。

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.