Study of Asthma and Nasal Steriods

哮喘和鼻类固醇的研究

• 批准号: 8501637
• 负责人: Anne E Dixon
• 金额: $ 22.5万
• 依托单位: UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
• 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/8501637
• 关键词: Accident and Emergency department; Acute; Address; Adrenal Cortex Hormones; Adult; Affect; American Lung Association; Area; Asthma; Breathing; Bronchial Hyperreactivity; Child; Chronic; Chronic Disease; Chronic Rhinitis; Chronic Sinusitis; Clinical; Clinical Research; Clinical Trials; Clinical Trials Cooperative Group; Commit; Comorbidity; Data; Data Coordinating Center; Disease; Effectiveness; Enrollment; Funding; Goals; Guidelines; Health; Healthcare; Healthy People 2010; Hypersensitivity; Hypersensitivity skin testing; Intervention; Lead; Link; Masks; Morbidity - disease rate; Nose; Nose Diseases; Office Visits; Participant; Patients; Placebo Control; Placebos; Pollen; Positioning Attribute; Public Health; Public Health Schools; Quality of life; Randomized; Reporting; Research; Rhinitis; Sinus; Sinusitis; Steroids; Symptoms; Time; United States; Visit; Work; double-blind placebo controlled trial; editorial; health care service utilization; improved; interest; patient population; programs; randomized trial; response; screening; tool

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）：这是向哮喘和鼻类固醇研究首席临床中心重新提交的申请；它与约翰·霍普金斯大学彭博公共卫生学院的罗伯特·怀斯博士提交的数据协调中心申请相关联。哮喘在美国是一个重要的公共卫生问题，哮喘控制不佳与显着的发病率和医疗保健利用有关。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 完成的试验结果表明，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。我们提议进行一项为期 6 个月的随机、双盲、安慰剂对照试验，招募 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敏感且特定的工具来识别哮喘患者的慢性鼻炎和鼻窦炎。除了常规哮喘治疗外，参与者还将随机接受鼻用类固醇或匹配的安慰剂。该试验的主要目的是评估添加鼻类固醇治疗是否可以改善哮喘控制。我们将对所有参与者进行皮肤过敏测试，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类固醇反应的重要因素。 ALA-ACRC 网络在确定治疗哮喘中慢性鼻炎和鼻窦炎的效果方面具有独特的优势；当前提案的结果将为指导哮喘控制不佳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。鼻炎和鼻窦炎可能导致哮喘恶化。当前提案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佳患者的治疗。