Pulmonary Unit, University of Verona, Verona, Italy
University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
Eur Respir J. 2014 Dec;44(6):1548-56. doi: 10.1183/09031936.00126814. Epub 2014 Oct 30.
The Indacaterol: Switching Non-exacerbating Patients with Moderate COPD From Salmeterol/Fluticasone to Indacaterol (INSTEAD) study investigated the effect of switching patients at low risk of chronic obstructive pulmonary disease (COPD) exacerbations from salmeterol/fluticasone (SFC; inhaled corticosteroid (ICS) regimen) to indacaterol monotherapy (non-ICS regimen). This 26-week, double-blind, double-dummy, parallel-group, phase IV study, randomised 581 patients with moderate COPD to indacaterol 150 μg once daily or SFC 50/500 μg twice daily. Patients had been receiving SFC 50/500 μg for ≥3 months, with no COPD exacerbations for more than a year before the study (patients for whom ICS is not recommended). The primary objective was to demonstrate non-inferiority of indacaterol to SFC, measured by trough forced expiratory volume in 1 second (FEV₁) after 12 weeks (non-inferiority margin of 0.06 L). The primary objective was met, with a mean treatment difference of 9 mL (95% CI -45-26 mL). There were no significant differences between treatments in terms of breathlessness (transition dyspnoea index) or health status (Saint George's Respiratory Questionnaire) at weeks 12 or 26, or rescue medication use or COPD exacerbation rates over 26 weeks. Safety profiles of both treatments were as expected. This study demonstrated that patients with moderate COPD and no exacerbations in the previous year can be switched from SFC to indacaterol 150 μg with no efficacy loss.
将患有中度 COPD 且无 COPD 加重史的患者由沙美特罗/氟替卡松转换为吲达特罗（INSTEAD）研究旨在评估将处于低风险 COPD 加重的患者由沙美特罗/氟替卡松（SFC；吸入性皮质类固醇（ICS）方案）转换为单药吲达特罗（非 ICS 方案）的效果。这项为期 26 周、双盲、双模拟、平行分组、四期研究，将 581 例中度 COPD 患者随机分为每日一次 150μg 吲达特罗组或每日两次 50/500μg SFC 组。这些患者之前已经接受 SFC 50/500μg 治疗≥3 个月，且在研究前一年以上无 COPD 加重史（不推荐使用 ICS）。主要目标是通过第 12 周时的谷值用力呼气量 1 秒率（FEV₁）来证明吲达特罗不劣于 SFC（非劣效性边界为 0.06L）。主要目标达到，治疗差异的平均值为 9mL（95%CI-45-26mL）。在第 12 周和第 26 周时，两种治疗方案在呼吸困难（过渡性呼吸困难指数）或健康状况（圣乔治呼吸问卷）方面没有显著差异，26 周期间的抢救药物使用或 COPD 加重率也没有差异。两种治疗方案的安全性特征均与预期一致。这项研究表明，过去一年无加重史的中度 COPD 患者可由 SFC 转换为吲达特罗 150μg，而不会导致疗效损失。
