COMPARISON OF CLINICAL BENEFIT, ANTIINFLAMMATORY EFFECT

临床疗效、抗炎作用比较

• 批准号: 6275443
• 负责人: Monica Kraft
• 金额: $ 3.14万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6275443
• 关键词: asthma; beta adrenergic agent; bronchoscopy; clinical research; clinical trials; diagnostic respiratory lavage; drug screening /evaluation; human subject; human therapy evaluation; inflammation; inhalation drug administration; respiratory disorder chemotherapy; triamcinolone

In patients with moderate asthma whose symptoms are well-controlled by using an inhaled B-agonist on an "as needed" basis and an inhaled corticosteroid on a scheduled basis, continued treatment with the inhaled corticosteroid does not differ in efficacy from a change to therapy with a long-acting B-agonist. This null hypothesis was proposed to examine the importance of anti-inflammatory therapy in altering symptoms, airway function, and bronchial reactivity in patients with moderate asthma. This protocol is the third from the NIH funded Asthma Clinical Research Network, a multi-center network formed in 1993 to evaluate pathogenesis and treatment of asthma. This will be a 28-week, randomized, double-blind, prospective multi-center trial comparing in subjects with moderate asthma the efficacy of an inhaled corticosteroid (triamcinolone acetonide) with that of an inhaled long-acting B-adrenergic agonist (salmeterol xinafoate) and with placebo, during 16 weeks of therapy, and for 6 weeks following cessation of therapy. After a 6 week run-in period, during which they receive inhaled corticosteroid (triamcinolone, 4 puffs BID) and as needed rescue albuterol, subjects will be randomized to receive either the inhaled corticosteroid (triamcinolone, 4 puffs BID) or salmeterol (2 puffs BID) or placebo (2 puffs BID) for the next 16 weeks. All subjects will be provided with albuterol inhalers to use as rescue medication throughout the study. Subjects will take the study medication for 16 weeks, then stop medication for an additional 6 week single-blind study period to examine the "off effect" of the medications. Bronchoscopy with bronchoalveolar lavage and endobronchial biopsy will be performed prior to randomization and at the end of treatment. Induced sputum will be performed at four points during the study: baseline, prior to randomization, after treatment, and end of run-out. Physiologic outcome variables include forced expiratory volume in one second (FEV1) measured in the laboratory, peak expiratory flow rate measured at home and the provocative concentration of methacholine required to produce a 20% fall in lung function (PC20). Variables reflective of airway inflammation include the absolute and percentages of macrophages, neutrophils, lymphocytes and eosinophile in sputum, bronchoalveolar lavage and endobronchial biopsy.

在症状得到良好控制的中度哮喘患者中， 在“按需”的基础上使用吸入性B-激动剂， 糖皮质激素，继续吸入治疗 皮质类固醇的疗效与改变治疗方法没有差异， 一种长效B受体激动剂提出该零假设是为了检查 抗炎治疗在改变症状、气道 功能和支气管反应性。 这 该方案是NIH资助的哮喘临床研究的第三个方案 网络，1993年形成的多中心网络，用于评估发病机制 和哮喘的治疗。这将是一项为期28周的随机、双盲、 在中度哮喘受试者中比较的前瞻性多中心试验 吸入性皮质类固醇（曲安奈德）与 吸入型长效β-肾上腺素能激动剂（昔萘酸沙美特罗） 在16周的治疗期间和6周后， 停止治疗。 经过6周的磨合期， 接受吸入性皮质类固醇（曲安奈德，4喷BID），并根据需要 补救沙丁胺醇，受试者将随机接受 吸入性皮质类固醇（曲安奈德，4喷BID）或沙美特罗（2 每日两次喷两次）或安慰剂（每日两次喷两次）治疗16周。 所有受试者 将提供沙丁胺醇吸入器作为急救药物 在整个研究中。 受试者将服用研究药物16 6周，然后停止药物治疗，进行额外的6周单盲研究 检查药物的“关闭效果”。支气管镜检查伴 在治疗前进行支气管肺泡灌洗和支气管内活检。 随机化和治疗结束时。诱导痰将 在研究期间的四个时间点进行：基线、 随机化、治疗后和终止试验结束。生理结局 变量包括测量的一秒用力呼气量（FEV 1 在实验室中，在家中测量呼气峰流速， 引起20%下降所需的乙酰甲胆碱激发浓度 肺功能（PC 20）。 反映气道炎症的变量 包括巨噬细胞，中性粒细胞， 痰液、支气管肺泡灌洗液中的淋巴细胞和嗜酸性粒细胞， 支气管内活检