Smoking in Asthmatics Pilot Study

吸烟与哮喘的试点研究

基本信息

批准号：
8446324
负责人：
JOE WESLEY RAMSDELL
金额：
$ 25.99万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN DIEGO
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-04-01 至 2015-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8446324
关键词：
Adrenal Cortex Hormones Adult Affect Agonist Albuterol American Lung Association Area Asthma Biological Biology Breathing Characteristics Clinical Clinical Research Clinical Trials Country Data Coordinating Center Disease Dose Feasibility Studies Funding Goals Health Individual Outcome Measure Patients Performance Pharmaceutical Preparations Pharmacotherapy Physiological Pilot Projects Protocols documentation Recruitment Activity Registries Relative (related person)Research Design Research Infrastructure Resistance Risk Role Sample Size Smoke Smoker Smoking Source Study Subject Symptoms Testing Theophylline Therapeutic United States abstracting alternative treatment asthmatic patient base comparative effectiveness design effective therapy improved montelukast non-smoker patient registry performance tests standard care tiotropium treatment as usual

项目摘要

DESCRIPTION (provided by applicant): Asthma is a major health problem in the United States affecting over 22 million individuals. 20 to 30% of asthmatics smoke and smoking asthmatics are relatively resistant to standard treatments. Paradoxically, asthmatics who smoke are routinely excluded from studies of asthma drug therapy. Treatment of asthmatics who are currently smoking is, therefore, an important but understudied area. There are unique aspects of the biology of smoking in asthma that impact treatment and suggest treatment alternatives. The use of inhaled corticosteroids (ICS) is the recommended first step in treating patients with persistent asthma. The combination of an ICS and a long-acting beta agonist (ICS/LABA) is the preferred action when ICS alone fails to achieve adequate control. What to do if control is not achieved with ICS/LABA is problematic. Smokers have a demonstrated resistance to ICS, montelukastand theophyllinemay be more effective in smoking asthmatics compared to non-smokers. Tiotropium is effective as add-on treatment of asthma but its role in smoking asthmatics is unknown. The relative benefits of these treatments have not been studied nor have they been compared to increasing ICS dose in smoking asthmatics with poorly controlled asthma symptoms. As a result, a definitive understanding of the best therapeutic approach to smoking asthmatics that are not adequately controlled with ICS/LABA alone has not been determined. The ultimate goal of the Smoking Asthmatics Pilot Study (SAPS) is a successful completion of the Theophylline/Tiotropium or Montelukast as Add-On Therapy in Smokers with Asthma Not Controlled with Combination ICS/LABA (TOM Trial). This proposed clinical trial will utilize the recruiting potential of the American Lung Association's Asthma Clinical Research Centers (ALA-ACRC) to directly compare four competing approaches to add-on therapy in smoking asthmatics with mild to moderate persistent asthma who are not adequately controlled by the currently recommended asthma treatments, i.e., ICS/LABA, in terms of symptomatic and physiologic endpoints of asthma management. SAPS consists of two protocols, the Network Protocol and the Vanguard Protocol, that will utilize the 19 Clinical Centers of the ALA-ACRC to assess recruitment, retention and compliance of smoking asthmatics and pilot a full-scale TOM Trial protocol at the UCSD ALA-ACRC Clinical Center. It will specifically assess the availability of adequate numbers of subjects for the study, test the performance characteristics of the proposed outcome measures in smoking asthmatics, test the feasibility of the study design and develop the infrastructure, including drug acquisition, necessary for timely initiation of recruitment of a ful-scale study.

描述（由申请人提供）：在美国，哮喘是影响超过2200万人的主要健康问题。 20％至30％的哮喘患者吸烟和吸烟哮喘患者对标准治疗相对抗药性。矛盾的是，哮喘患者通常被排除在哮喘药物治疗研究之外。因此，目前正在吸烟的哮喘患者是一个重要但正在研究的地区。哮喘中吸烟生物学的独特方面会影响治疗并建议治疗替代方法。吸入皮质类固醇（IC）的使用是治疗持续性哮喘患者的建议第一步。当ICS/LABA（ICS/LABA）的结合是当ICS仅实现足够的控制时，是首选的作用。如果无法通过ICS/LABA实现控制该怎么办是有问题的。与非吸烟者相比，吸烟者表现出对ICS的抗药性，蒙特鲁卡斯岛和theophyllinemay在吸烟哮喘患者方面更有效。 tiotopium是哮喘的附加治疗方法有效的，但其在吸烟哮喘患者中的作用尚不清楚。这些疗法的相对好处尚未被研究，也没有将其与增加哮喘症状不良的吸烟哮喘患者的ICS剂量进行比较。结果，尚未确定对不充分控制ICS/LABA的最佳治疗方法的确定理解。吸烟哮喘试验研究（SAPS）的最终目标是成功完成茶碱/tiotopium或Montelukast作为吸烟者的附加疗法，该疗法无法通过ICS/LABA组合控制（TOM试验）。这项提出的临床试验将利用美国肺协会的哮喘临床研究中心（ALA-ACRC）的招募潜力，直接比较四种在吸烟哮喘中的竞争方法，具有轻度至中度持续的哮喘，这些方法并未受到当前推荐的哮喘治疗，即及时的ASE ASIC/ICS ASA，ICS/ICS ASMA，ICS/ICS ASMANICS。管理。 SAPS由两个方案组成：网络协议和先锋协议，这些方案将利用ALA-ACRC的19个临床中心评估吸烟哮喘患者的招聘，保留和遵守范围，并在UCSD ALA-ALA-ACRC临床中心进行全面的TOM试验方案。它将特别评估该研究的足够数量的受试者的可用性，测试吸烟哮喘患者提出的结果指标的性能特征，测试研究设计的可行性并开发基础设施，包括药物获取（包括药物获取，对于及时招募一项充实的研究）。