Smoking in Asthmatics Pilot Study

描述（由申请人提供）： 哮喘是美国的一个主要健康问题，影响超过2200万人。20%至30%的哮喘患者吸烟，吸烟的哮喘患者对标准治疗相对抵抗。奇怪的是，吸烟的哮喘患者通常被排除在哮喘药物治疗的研究之外。因此，目前吸烟的哮喘患者的治疗是一个重要但未充分研究的领域。哮喘中吸烟生物学的独特方面影响治疗并建议治疗方案。使用吸入性皮质类固醇（ICS）是治疗持续性哮喘患者的第一步。当单独使用ICS无法实现充分控制时，ICS和长效β受体激动剂（ICS/LABA）的组合是首选措施。如果ICS/LABA无法实现控制，该怎么办是一个问题。吸烟者对ICS有明显的抵抗力，与非吸烟者相比，孟鲁卡和茶碱可能对吸烟哮喘患者更有效。噻托溴铵作为哮喘的辅助治疗是有效的，但其在吸烟哮喘患者中的作用尚不清楚。这些治疗的相对益处尚未研究，也没有将其与哮喘症状控制不佳的吸烟哮喘患者中增加ICS剂量进行比较。因此，对于单独使用ICS/LABA不能充分控制的吸烟哮喘患者的最佳治疗方法尚未确定。吸烟哮喘初步研究（SAPS）的最终目标是成功完成茶碱/噻托溴铵或孟鲁司特作为ICS/LABA联合治疗未控制的吸烟哮喘患者的辅助治疗（TOM试验）。这项拟议的临床试验将利用美国肺脏协会哮喘临床研究中心（ALA-ACRC）的招募潜力，直接比较四种竞争性方法，用于目前推荐的哮喘治疗无法充分控制的轻度至中度持续性哮喘吸烟哮喘患者的添加治疗，即，ICS/LABA，哮喘管理的症状和生理终点。SAPS由两个协议组成，网络协议和先锋协议，将利用ALA-ACRC的19个临床中心来评估吸烟哮喘患者的招募，保留和依从性，并在UCSD ALA-ACRC临床中心试行全面的TOM试验协议。它将专门评估是否有足够数量的受试者可用于研究，测试吸烟哮喘患者中拟定结局指标的性能特征，测试研究设计的可行性，并开发及时启动全规模研究招募所需的基础设施，包括药物采购。

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.