Division of Allergy and Immunology, University of South Florida Morsani College of Medicine, Tampa, FL, USA.
Martini Hospital, Groningen, Netherlands.
Respir Med. 2019 Oct-Nov;158:97-109. doi: 10.1016/j.rmed.2019.09.014. Epub 2019 Sep 30.
Despite currently available therapies and detailed treatment guidelines, many patients with asthma remain symptomatic. Tiotropium delivered by the soft mist inhaler Respimat®, as add-on therapy to medium-dose inhaled corticosteroids (ICS), has been shown to improve lung function and asthma control in patients with symptomatic moderate asthma.
To determine whether the efficacy of tiotropium Respimat® in asthma differs by patients' study baseline characteristics.
Two replicate Phase III, randomized, double-blind, placebo-controlled, parallel-group studies (MezzoTinA-asthma®; NCT01172808 and NCT01172821) of once-daily tiotropium Respimat 5 μg and 2.5 μg add-on to ICS were conducted in patients with symptomatic asthma despite treatment with medium-dose ICS with or without additional controllers. Subgroup analyses of peak forced expiratory volume in 1 s (FEV), trough FEV, risk of severe asthma exacerbation and Asthma Control Questionnaire responder rate were performed to determine whether results were influenced by patients' baseline characteristics.
In this analysis, 523 patients received placebo while 517 and 519 patients received the 5 μg and 2.5 μg dose of tiotropium Respimat, respectively. The magnitude of the improvements in lung function and asthma control, as well as the reduced risk of severe exacerbation with both doses of tiotropium Respimat versus placebo, was independent of a broad range of baseline characteristics.
Once-daily tiotropium Respimat as add-on to ICS is a beneficial treatment option for patients with asthma who remain symptomatic despite at least medium-dose ICS, regardless of baseline characteristics.
尽管目前有多种疗法和详细的治疗指南，但许多哮喘患者仍存在症状。噻托溴铵通过软雾吸入器 Respimat®给药，作为中剂量吸入皮质类固醇（ICS）的附加治疗，已被证明可改善有症状的中度哮喘患者的肺功能和哮喘控制。
确定噻托溴铵 Respimat®在哮喘中的疗效是否因患者的研究基线特征而异。
两项复制的 III 期、随机、双盲、安慰剂对照、平行组研究（MezzoTinA-asthma®；NCT01172808 和 NCT01172821），评估了噻托溴铵 Respimat 每日一次 5μg 和 2.5μg 与 ICS 联合治疗对症状性哮喘患者的疗效，这些患者尽管接受了中剂量 ICS 治疗，但仍有症状，且接受或未接受附加控制器治疗。进行了最大呼气流量峰值（PEF）、PEF 谷值、严重哮喘加重风险和哮喘控制问卷应答率的亚组分析，以确定结果是否受患者基线特征的影响。
在这项分析中，523 名患者接受了安慰剂，而 517 名和 519 名患者分别接受了噻托溴铵 Respimat 的 5μg 和 2.5μg 剂量。与安慰剂相比，噻托溴铵 Respimat 两种剂量均能显著改善肺功能和哮喘控制，降低严重加重风险，其疗效与广泛的基线特征无关。
噻托溴铵 Respimat 作为 ICS 的附加治疗，是一种有益的治疗选择，适用于即使接受了至少中剂量 ICS 治疗后仍有症状的哮喘患者，无论其基线特征如何。
