勃林格殷格翰（Boehringer Ingelheim）3月1日公布了药物tiotropium Respimat（tiotropium，通用名：噻托溴铵，商品名：Spiriva Respimat，思力华）大规模III期项目的新数据，这些新数据表明，tiotropium Respimat在横跨不同严重程度的哮喘患者群体中均有效，同时耐受性良好。相关数据已提交至美国过敏、哮喘、免疫学会（AAAAI）2014年会。
尽管当前已有多种治疗方案，但至少有40%的哮喘患者仍存在哮喘症状，这可能会使他们面临更大的病情恶化或哮喘恶化风险。因此，在横跨不同严重程度的哮喘患者群体中，调查新治疗方案的疗效和安全性，是非常重要的。
公布的III期GraziaTinA-asthma研究的首批数据证实，在接受低剂量维持性ICS治疗但仍存在哮喘症状的患者群体中，tiotropium Respimat?能够改善患者的肺功能，同时耐受性良好。
III期MezzoTinA-asthma研究新子集数据表明，在接受中等剂量维持性ICS治疗但仍存在哮喘症状的患者群体中，添加每日一次的tiotropium Respimat治疗，能够减少气流阻塞，这种改善独立于TH2表型生物标志物测定的过敏状态。
III期PrimoTinA-asthma研究子集分析数据发现，添加每日一次的tiotropium Respimat治疗改善了肺功能，这种改善独立于一种白三烯受体拮抗剂（LTRA）的合并使用（concomitant use）。这一效应在接受至少ICS/LABA疗法但仍存在哮喘症状的患者群体中得到证实。
此前，III期PrimoTinA-asthma研究的数据表明，与当前标准疗法（ICS/LABA）相比，添加tiotropium Respimat，能够显著推迟首次严重哮喘发作的时间、以及首次哮喘恶化发作的时间。
目前，tiotropium Respimat已获批用于慢性阻塞性肺病（COPD）的治疗。勃林格殷格翰于2013年11月，向欧盟提交了tiotropium Respimat扩大适应症申请，寻求批准用于18岁及以上成人哮喘（asthma）患者的治疗。
ASTHMA: New Phase III data show tiotropium* Respimat? effective across asthma severities
—Significant unmet medical need in patients with asthma who continue to experience symptoms despite current standard treatments
—Improved understanding of tiotropium Respimat? as add-on treatment for patients with different severities of asthma
—Results add to existing evidence of efficacy and safety of tiotropium Respimat? in patients who remained symptomatic despite treatment with at least ICS?/LABA
San Diego, CA, March 1, 2014 – Boehringer Ingelheim today announced new data from large scale, Phase III studies showing that once-daily tiotropium delivered via the Respimat? inhaler was effective and well tolerated in patients across asthma severities. These data were presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2014 annual meeting in San Diego.
“Even with current treatment options, at least 40 percent of patients with asthma remain symptomatic,1 which may put them at greater risk for exacerbations or asthma worsening" said Professor Pierluigi Paggiaro, Professor of Respiratory Medicine, University of Pisa, and lead author on the GraziaTinA-asthma? study. “It is imp0rtant to investigate the efficacy and safety of new treatment options across different asthma severities.”
The first results from the Phase III GraziaTinA-asthma? study were announced. The study demonstrated that tiotropium Respimat? improved lung function and was well tolerated in patients with asthma who remain symptomatic while receiving low-dose maintenance ICS treatment.2
Also presented at the meeting was a new subset of data from the Phase III MezzoTinA-asthma? trials. The data showed that in patients with asthma who remained symptomatic while receiving moderate-dose maintenance ICS therapy, the addition of once-daily tiotropium reduced airflow obstruction independent of allergic status, as measured by the TH2 phenotype biomarker.3
Finally, an analysis of a subset from the Phase III PrimoTinA-asthma? trials found the addition of once-daily tiotropium improved lung function responses independently of concomitant use of a leukotriene receptor antagonist (LTRA). This effect was demonstrated in patients with asthma who remained symptomatic despite receiving treatment with at least ICS/LABA.4 Previous results from these pivotal, PrimoTinA-asthma? trials have shown that the addition of tiotropium Respimat? significantly increased time to first severe asthma exacerbation, as well as time to first episode of asthma worsening, compared with at least ICS/LABA therapy alone (current standard therapy).5
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