Safety Profile of Tiotropium + Olodaterol Used as Maintenance Treatment in COPD Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data

The aim of this real world study is to assess the safety profile of tiotropium/olodaterol (Tio/Olo).

开始日期2022-09-30

申办/合作机构

Boehringer Ingelheim GmbH

100 项与噻托溴铵奥达特罗相关的临床结果

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100 项与噻托溴铵奥达特罗相关的转化医学

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100 项与噻托溴铵奥达特罗相关的专利（医药）

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174

项与噻托溴铵奥达特罗相关的文献（医药）

2024-08-08·Expert review of pharmacoeconomics & outcomes research

Improved medication adherence in COPD patients using tiotropium or tiotropium olodaterol with the HealthPrize digital behavior change program

Article

作者: DeKoven, Mitchell ; Shaikh, Asif ; Firlik, Katrina S ; Anupindi, Vamshi Ruthwik ; Hayes, Vincent ; Franchino-Elder, Jessica

OBJECTIVE:

To assess the impact of the HealthPrize RespiPoints™ program on treatment adherence and persistence in adults with chronic obstructive pulmonary disease (COPD).

METHODS:

In this retrospective cohort study, program participants and nonparticipants receiving tiotropium bromide (TIO) or TIO and olodaterol between 1 January 2015-31 March 2020 were propensity score matched (PSM), from the linked database of the HealthPrize patient list and IQVIA PharMetrics® Plus. Treatment adherence, persistence, healthcare resource utilization, and costs were compared. Multivariable logistic regression models assessed the odds of adherence (≥80% proportion of days covered [PDC]), adjusted risk of discontinuation, and adjusted total healthcare costs.

RESULTS:

Program participants (n = 262) demonstrated a 44% greater adherence during followup than nonparticipants (n = 262) (mean [standard deviation] PDC: 0.72 [0.27] vs 0.50 [0.36], p < 0.0001). Participants had higher odds of adherence vs nonparticipants (adjusted odds ratio: 2.51; 95% confidence interval: 1.72-3.66, p < 0.0001) and a lower percentage of participants discontinued their index medication (19.85% vs 33.59%, p = 0.0004). Fewer participants were hospitalized during follow-up (13.74% vs 17.56%, p = 0.23); adjusted total medical costs were 24% lower (p = 0.08). Higher pharmacy costs partially offset lower healthcare costs.

CONCLUSIONS:

Program participants showed improved COPD medication adherence and persistence compared to nonparticipants.

2023-07-01·Advances in therapy

EVELUT®: A Real-World, Observational Study Assessing Dyspnoea and Symptom Burden in COPD Patients Switched from LABA/ICS to LAMA/LABA or LAMA/LABA/ICS.

Article

作者: Taube, Christian ; Buhl, Roland ; Dreher, Michael ; Vogelmeier, Claus F ; Eckhardt, Sebastian ; Emerson-Stadler, Rachel ; Mattiucci-Guehlke, Muriel

INTRODUCTION:

The Global Initiative for Chronic Obstructive Lung Disease (GOLD 2023) no longer recommends a long-acting β₂-agonist (LABA) plus inhaled corticosteroid (ICS) combination for the treatment of chronic obstructive pulmonary disease (COPD). In patients treated with LABA/ICS, who continue to experience symptoms without frequent or severe exacerbations, GOLD now recommends switching to long-acting muscarinic antagonist (LAMA)/LABA instead of escalating to triple therapy (TT; LAMA/LABA/ICS), which previously was also a recommended option. EVELUT^®, a real-life, observational study, compared these two treatment strategies in terms of symptom relief and health status improvement.

METHODS:

Patients with symptomatic COPD at low exacerbation risk (GOLD B) were switched, at their physicians' discretion, from LABA/ICS to either fixed-dose LAMA/LABA (tiotropium/olodaterol, Respimat^® [Tio/Olo]) or fixed or free TT. Primary endpoints were change in modified Medical Research Council (mMRC) and COPD Assessment Test™ (CAT™) scores after 12 weeks.

RESULTS:

The safety set contained 463 patients (Tio/Olo, n = 329; TT, n = 134). In a propensity score-matched set (Tio/Olo, n = 121; TT, n = 121), improvement in mMRC score was similar in patients on Tio/Olo (-0.23; 95% confidence interval [CI] -0.11, -0.36) and TT (-0.25; 95% CI -0.13, -0.38). Improvement in total CAT score was slightly larger in patients on Tio/Olo (-3.45; 95% CI -2.45, -4.45) versus TT (-2.51; 95% CI -1.62, -3.40). In both groups, Physician's Global Evaluation scores increased, with 69-89% of patients satisfied with their treatment overall. Marginally more patients on Tio/Olo responded to treatment versus TT (Δ mMRC score ≥ 1; 25% vs. 22%; Δ CAT score ≥ 2, 68% vs. 56%).

CONCLUSION:

In patients with symptomatic COPD at low exacerbation risk, treatment can be switched from LABA/ICS to LAMA/LABA without compromising clinical benefit, compared with escalating to LAMA/LABA/ICS. Switching from LABA/ICS to LAMA/LABA can provide symptom relief and improve health status without exposure to the risks associated with ICS.

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov: NCT03954132.

2023-07-01·Journal of managed care & specialty pharmacy

Clinical and economic outcomes in patients with chronic obstructive pulmonary disease initiating maintenance therapy with tiotropium bromide/olodaterol or fluticasone furoate/umeclidinium/vilanterol.

Article

作者: Buysman, Erin K ; Ferguson, Gary T ; Shaikh, Asif ; Sargent, Andrew ; Palli, Swetha R ; Sethi, Sanjay ; Bengtson, Lindsay G S ; Clark, Brendan

BACKGROUND: Clinical practice guidelines recommend dual long-acting muscarinic antagonists (LAMAs)/long-acting β₂agonists (LABAs) as maintenance therapy in patients with chronic obstructive pulmonary disease (COPD) and dyspnea or exercise intolerance. Escalation to triple therapy (TT) (LAMA/LABA/inhaled corticosteroid) is conditionally recommended for patients with continued exacerbations on dual LAMA/LABA therapy. Despite this guidance, TT use is widespread across COPD severities, which could impact clinical and economic outcomes. OBJECTIVE: To compare COPD exacerbations, pneumonia events, and disease-related and all-cause health care resource utilization and costs (in 2020 US dollars) in patients initiating fixed-dose combinations of either LAMA/LABA (tiotropium/olodaterol [TIO + OLO]) or TT (fluticasone furoate/umeclidinium/vilanterol [FF + UMEC + VI]). METHODS: This retrospective observational study of administrative claims included patients with COPD aged 40 years or older initiating TIO + OLO or FF + UMEC + VI from June 2015 to November 2019. TIO + OLO and FF + UMEC + VI cohorts in the overall and maintenance-naive populations were 1:1 propensity score matched on baseline demographics, comorbidities, COPD medications, health care resource utilization, and costs. Multivariable regression compared clinical and economic outcomes up to 12 months in FF + UMEC + VI vs TIO + OLO postmatched cohorts. RESULTS: After matching, there were 5,658 and 3,025 pairs in the overall and maintenance-naive populations, respectively. In the overall population, the risk of any (moderate or severe) exacerbation was 7% lower in FF + UMEC + VI vs TIO + OLO initiators (adjusted hazard ratio [aHR] = 0.93; 95% CI = 0.86-1.0; P = 0.047). There was no difference in the adjusted risk of any exacerbation in the maintenance-naive population (aHR = 0.99; 95% CI = 0.88-1.10). Pneumonia risk was not statistically different between cohorts in the overall (aHR = 1.12; 95% CI = 0.98-1.27) and maintenance-naive (aHR = 1.13; 95% CI = 0.95-1.36) populations. COPD- and/or pneumonia-related adjusted total annualized costs (95% CI) were significantly greater for FF + UMEC + VI vs TIO + OLO in the overall ($17,633 [16,661-18,604] vs $14,558 [13,709-15,407]; P < 0.001; differences [% of relative increase] = $3,075 [21.1%]) and maintenancenaive ($19,032 [17,466-20,598] vs $15,004 [13,786-16,223]; P < 0.001; $4,028 [26.8%]) populations, with significantly higher pharmacy costs with FF + UMEC + VI (overall: $6,567 [6,503-6,632] vs $4,729 [4,676-4,783]; P < 0.001; $1,838 [38.9%]; maintenance-naive: $6,642 [6,560-6,724] vs $4,750 [4,676-4,825]; P < 0.001; $1,892 [39.8%]). CONCLUSIONS: A lower risk of exacerbation was observed with FF + UMEC + VI vs TIO + OLO in the overall population but not among the maintenance-naive population. Patients with COPD initiating TIO + OLO had lower annualized costs than FF + UMEC + VI initiators in the overall and maintenance-naive populations. Thus, in the maintenance-naive population, initiation with dual LAMA/LABA therapy per practice guidelines can improve real-world economic outcomes. Study registration number: ClinicalTrials.gov (identifier: NCT05127304). DISCLOSURES: The study was funded by Boehringer Ingelheim Pharmaceuticals, Inc (BIPI). To ensure independent interpretation of clinical study results and enable authors to fulfill their role and obligations under the ICMJE criteria, BIPI grants all external authors access to relevant clinical study data. In adherence with the BIPI Policy on Transparency and Publication of Clinical Study Data, scientific and medical researchers can request access to clinical study data after publication of the primary manuscript in a peer-reviewed journal, regulatory activities are complete and other criteria are met. Dr Sethi has received honoraria/fees for consulting/speaking from Astra-Zeneca, BIPI, and GlaxoSmithKline. He has received consulting fees for serving on data safety monitoring boards from Nuvaira and Pulmotect. He has received consulting fees from Apellis and Aerogen. His institution has received research funds for his participation in clinical trials from Regeneron and AstraZeneca. Ms Palli was an employee of BIPI at the time the study was conducted. Drs Clark and Shaikh are employees of BIPI. Ms Buysman and Mr Sargent are employees and Dr Bengtson was an employee of Optum, which was contracted by BIPI to conduct this study. Dr Ferguson reports grants and personal fees from Boehringer Ingelheim during the conduct of the study; grants from Novartis, Altavant, and Knopp; grants and personal fees from AstraZeneca, Verona, Theravance, Teva, and GlaxoSmithKline; and personal fees from Galderma, Orpheris, Dev.Pro, Syneos, and Ionis outside the submitted work. He was a paid consultant for BIPI for this study. The authors received no direct compensation related to the development of the manuscript. BIPI was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations.

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攻克高壁垒软雾剂和数款干粉吸入给药装置，艾特申博推出一站式给药装置服务

根据WHO披露的数据，全球有6亿呼吸慢病患者，中国有1.5亿呼吸慢病患者，包括哮喘和慢阻肺（COPD）患者。国内COPD死亡率远高于世界平均水平，是中国第四大死亡原因。每年因COPD死亡的人数超过100万，致残人数超过500万。COPD和哮喘是可控制却不可治愈的疾病，需要对症控制，应用药物也分为长期控制用药和短期缓解用药。对于呼吸疾病患者而言，吸入给药更能巧妙结合生理、组织学特点，直接作用于呼吸道和肺部并进入循环代谢，起效迅速、给药方便、用药剂量小、避免肝脏首过效应、毒副作用小等优势。作为呼吸系统疾病首选给药制剂，吸入制剂早已被广泛应用于临床实践。 2021年全球吸入制剂销售额超500亿美元，但集中于全球“呼吸药物三巨头”阿斯利康（AZ）、葛兰素史克（GSK）和勃林格殷格翰（BI），国内通过一致性评价的吸入仿制药在很长一段时间内处于低值，并集中于雾化溶液剂（NEB）。吸入制剂因较高的研发、生产和审批壁垒，缺乏工程化与产业化经验，仿制难度极高。此外，吸入制剂特有的药械组合需要药品和吸入装置联合使用，也存在极高的技术壁垒，长期被PARI、Aerogen等给药装置巨头垄断。始创于2021年底的艾特申博（苏州）医药科技有限公司（后简称“艾特申博”）专注于提供给药装置一站式服务，具有装置设计开发、生产和配送的全流程能力，支持中国、美国和欧洲的医疗器械、药包材(DMF)与药品的关联申报。成立不足3年，艾特申博深耕于多种复杂给药装置的开发，已提交超过70个专利申请，且发明专利为主。2024年，艾特申博团队完成了噻托溴铵奥达特罗软雾制剂（商品名思合华，为BI原研、获批上市的软雾剂）的正式生物等效性实验（简称PK-BE）。吸入软雾制剂：多学科交叉与复杂生产工艺的集成之作吸入制剂主要分为四大类，包括气雾剂（MDI），干粉剂（DPI）、雾化溶液（NEB）、软雾剂（SMI）。研发与技术难度上看，以设计精密的软雾剂（SMI）和干粉剂（DPI）为甚。 “这两类吸入制剂都涉及多学科交叉、专利与设计复杂，导致研发端和产业端的相对空白。”艾特申博总经理任红贤在接受采访时提到，“以软雾芯片开发为例，就涉及半导体行业的蚀刻工序，还涉及空气动力学、机械、化学、精密测量等环节。关键在产业化过程中，需要保证每一步良率都很高，才能保证最终良率。因为软雾芯片工序非常多，所以即使每一步良率达到98%，但结果总体良率只有80%，还是没有办法进行产业化生产，不良太高造成的成本会无法下来，可喜的是我们每一站工序良率都是极高”。干粉剂（DPI），是固体微粉化原料药物单独或与合适载体混合后，以胶囊、泡囊或多剂量贮库形式，采用特制的干粉吸入装置，由患者吸入药物至肺部。该装置可随身携带，对患者吸气流速有一定要求。在粉雾剂的研制中，颗粒工程、工艺开发、工艺放大、给药装置都具挑战性：混合过程是粉雾剂制备的关键步骤，涉及能量输入、颗粒间相互作用，最终形成均匀稳定的粉雾体系，要求粉雾体系能在相当长的时期内多次重现相同雾化过程。因此混合强度、时间、温度、湿度等因素都可能影响药物颗粒在吸入过程中的空气运动形态，从而影响药物在肺部的分布，最终影响临床效果。艾特申博专利干粉给药装置艾特申博目前已搭建起标准现成的干粉给药装置平台，包括Generic Handihaler、Breezhaler和舒利迭给药装置，还可提供定制化的外观设计。软雾剂（SMI），为无源便携式吸入给药装置，且为自带动力的主动型给药，对患者吸气流速依赖性降低。软雾剂一方面通过旋转底座的压缩弹簧所产生的机械能为动力，为药物释放气溶胶提供能量，另一方面通过毛细管和精密微注塑的单向阀精准定量、独特的两束药液射流对撞原理，以特定角度撞击形成独特“软雾”。同时软雾剂剂量精准稳定，给药时间适中（约1.5s），手口协调性要求低，适用于儿童、老人等给药困难人群。不过，精密雾化装置是各类精密雾化元件的集成，包括半导体元件及定量、液体传输部分，具有非常高的设计和精密制造壁垒。任红贤介绍，在攻克软雾剂方面，艾特申博首先规避了专利风险，研发工程师自己做了大量的专利检索比对，也委托专业的专利代理所做了中、美、欧专利FTO检索，专利风险为低。其次，为了让软雾给药微细粒子量达到70%—80%，艾特申博团队做了很多尝试。相比于传统气雾剂和干粉粉雾剂仅可达到20%—30%，软雾给药的微细粒子量是非常惊人的——实验表明，其软雾剂2x2.5微克的喷药量的疗效相当于干粉粉雾剂18微克给药量的疗效，软雾剂的肺部沉积率可超普通干粉和气雾剂的三倍。（艾特申博专利软雾给药装置）分析指出，对比2018年中美吸入制剂销售数据，中国市场雾化溶液占比超过40%，而美国市场主流剂型是随身携带控制用药的干粉剂和粉雾剂，占据市场份额超过80%。这提示，主动型、便携式、高效给药已经成为吸入制剂装置发展重要趋势。随着国产替代和上游产业兴起，干粉剂和粉雾剂、软雾剂在价格上的劣势将被追平，并进一步推广在药品及临床应用。对标中、美、欧标准，建立给药装置全产业链、一站式服务自成立落地起，艾特申博就选择了“研发中心+工业化制造中心”的双中心路线，打造出全球领先的软雾给药装置全产业链，从精密高穴位模具开发、工艺开发与验证、精密零件注塑、液态硅胶注塑、精密毛细管加工，到芯片封装、双层瓶生产以及全自动化的装配检测等均有深度布局。任红贤强调，“双中心定位关键在于强化创新，既强化新产品研发，也要强化产业落地。吸入装置对于吸入制剂影响非常大，装置变更属于重大变更，因此如果研发与生产落地衔接不好，会造成后续无法实现产业化的问题。” 正在进行的软雾喷雾几何形态检测实验产业端，艾特申博目前在苏州高新区建成了4000平方米ISO 8等级的净化车间与世界一流的生产与检验设备，具有独立的微生物检验（阳性与阴性对照），光学检查，材料鉴别，物理化学特性检验的实验室。据此，艾特申博提供给药装置一站式服务，包括产品设计、结构设计、公差分析、材料选择、多相流仿真分析、精密模具开发、工艺验证、精密注塑、产品验证、组装与预BE仿真等一体化服务。基于微量雾化给药技术，艾特申博也在研发更多复杂给药装置，如经鼻进脑给药、眼科微量雾化给药等。与此同时，艾特申博从成立之初就定下了全球化发展的目标。研发与产线建设均依据满足中美欧三地的法规进行规划设计，并邀请到全球知名的德国技术监督协会组织TUV-Sud集团进行ISO-13485的第三方认证。目前可以按照美国药典标准、欧洲药典标准、中国药典和中国药包材YBB标准各项检验，制造流程可以符合药包材和医疗器械两套标准。全产业链和全球化布局之下，艾特申博垂直整合团队，融会贯通装置开发、制剂开发、生物等效性实验的丰富经验。团队目前已积累13款吸入给药装置开发经验，包括4个通过正式PK-BE装置和8个通过预PK-BE装置。“垂直整合团队有利于强化创新过程中的沟通和产品的快速开发，既懂产品应用、客户体验，也理解生产关键、考虑可行性和QbD，更快推进量产。” 吸入制剂及装置的未来：国产替代与全球创新时至今日，随着创新药靶点、机制内卷加剧、一二级市场融资困难，创新药企研发费用上升，抗风险能力却在下降。因此，越来越多国内制药企业将目光投向复杂仿制药、药械组合申报。开发效用更高、可及性更好的吸入剂型，或申报药械组合产品、或搭建剂型壁垒都成为药企延长产品生命周期、强化自身竞争力的一大趋势。另外，随着AZ、GSK、BI重磅药物及配套给药装置的专利逐步到期，NMPA对于吸入制剂及药械联合申报的监管和规则日趋成熟。上游精密制造加工发展也满足了中下游产业在元器件供应、精密加工工艺等方面的需求。国内大集采环境下，大批国产制药企业正在跟进相关仿制药申报，实现吸入剂型药物及装置的国产替代，抢占长期占统治地位的原研药市场。国内吸入制剂市场需求持续增长，同时伴随仿制药放量有望保持稳健增长。Frost&Sullivan数据显示，2017—2021年，中国呼吸系统疾病吸入制剂市场规模从125亿元增长到195亿元，年复合增长率为12%，预计到2025年和2030年分别增长至239亿和276亿元。合作无疑是吸入装置创新企业重要的商业化机会。对于大型药企而言，自研软雾制剂及装置需要投入亿元级别的研发、生产与产业链建设，并需要等待2～3年，可能错过突围的关键节点。如果和艾特申博这类开发型企业合作，只需要千万级别授权费用，即可直接拿到经过验证的吸入制剂装置，并获得一站式服务与深度研发合作。全球范围内，吸入制剂创新及潜在应用的扩展仍是一片蓝海，可作为生物大分子、蛋白质非注射给药的替代方式。随着脂质体、外泌体、纳米粒、纳米乳等新型药物传输载体崛起，其肺部应用的缓释性、低毒性和局部靶向性，在一定程度上提升药物稳定性，正逐步被用于吸入制剂开发，让蛋白类、多肽类、DNA/RNA类、抗体类药物的吸入给药成为可能。此外，应用场景创新也是吸入给药制剂尚待挖掘的宝地。以软雾剂为例，除呼吸道、口腔给药外，还可拓展至皮肤护理、眼部及鼻腔护理等个人护理领域、宠物医疗护理等。由于广阔的市场前景，欧美不少创新给药装置企业也在积极布局，例如中国生物制药1.1亿美元收购Softhale；开发干粉和软雾剂装置的吸入装置创新企业Merxin获得数千万美元融资；开发鼻喷以及各类护理、医用给药装置企业Medspray和Recipharm集团成立了合资公司Resyca专门开发软雾剂装置。 * 参考资料：道彤投资《千亿吸入给药制剂市场背后潜藏的高壁垒赛道，国产替代正当时》https://www.vbdata.cn/1518915210 上海生物医药基金《吸入制剂百亿市场：国产替代方兴未艾》https://www.chinaventure.com.cn/news/108-20230106-373045.html 如果您想对接文章中提到的项目，或您的项目想被动脉网报道，或者发布融资新闻，请与我们联系；也可加入动脉网行业社群，结交更多志同道合的好友。近期推荐声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。动脉网，未来医疗服务平台

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2024-06-19

·药融圈

大股东自掏腰包，5亿重金砸在制药领域

▲8月15-16日 NDC2024生物医药创新者峰会扫码报名注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。药融云数据www.pharnexcloud.com监测显示：2024年4月27日，科创板上市公司博瑞医药（688166.SH）发布2023年报，总营业收入11.8亿元人民币，同比增长15.9%；2023财年净利润2.02亿。2024年第一季度总营收3.4亿，同比增长11.5%；扣非净利润6421万元。 2023年报中，博瑞医药提到GLP-1：将从探索口服制剂、超长效缓释制剂、微针制剂等新型给药方式，拓展新的临床应用空间，以及联合其他靶点、拓展新治疗领域等三方面开展差异化竞争。新药候选分子 BGM0504是博瑞医药自主研发的GLP-1/GIP双重激动剂。（近期调研报告表示：等 Ⅱ期临床结果出来，公司会同 CDE 讨论Ⅲ期临床情况，希望能尽快启动Ⅲ期临床。全球化布局这块，公司会把欧美日韩作为一个板块，东南亚、南美、中东北非等作为其他板块。）药融云数据www.pharnexcloud.com；词条 BGC0228：靶向高分子偶联药物PDC，能靶向肿瘤组织高度表达的CD44。 PSMA-0057：核药-放射性药物（RDC），目前处于临床前研究阶段。吸入制剂领域投入重点开发经口吸入、眼科喷雾、经鼻入脑三个方向。目前，吸入用布地奈德混悬液已在国内申报，噻托溴铵奥达特罗吸入喷雾剂已完成BE试验（生物等效性试验），噻托溴铵吸入喷雾剂完成稳定性研究，沙美特罗替卡松吸入粉雾剂完成工艺验证，噻托溴铵吸入粉雾剂已经完成中试。传统的强项领域博瑞医药2023年原料药合计销售额8.9亿元，同比增长14%，占总营收75%。公司的境外销售收入为3.97亿元，占主营收入的34.19%。制剂领域产品 2023年营收1.38亿元，受益注射用米卡芬净钠2022年药品集采中标，同比增长37%。2024年第一季度，博瑞医药制剂领域产品收入5658万元，增长21%。定增 2024年5月7日，博瑞医药发布公告：公司拟向实控人之一袁建栋发行股票募集资金总额不超过5亿元（含本数），发行价格为22.56元/股，募集资金全部拟用于补充流动资金和偿还银行贷款。公司表示通过本次定增，公司可以有效缓解资金压力，降低财务费用，增强公司盈利水平和抗风险能力。（研发+在建工程+贷款+运营投入需要花费不少资金） 2021年至2023年，博瑞医药研发费用分别为1.73亿元、2.07亿元和2.49亿元。关于博瑞：博瑞生物医药（苏州）股份有限公司依靠研发驱动，聚焦于首仿、难仿、特色原料药、复杂制剂和原创性新药，持续打造高技术壁垒，逐步建立起原料药与制剂一体，仿制药与创新药结合，国际市场与国内市场并重的业务体系，致力于满足全球患者未被满足的临床需求。目前已形成发酵半合成平台、多手性药物平台、非生物大分子平台、药械组合平台及偶联药物平台等药物技术研发平台，产品覆盖抗真菌、抗病毒、免疫抑制、抗肿瘤、心脑血管、呼吸、补铁剂、兽药、辅料等领域。参考： NMPA/CDE；药融云数据www.pharnexcloud.com； FDA/EMA/PMDA；相关公司公开披露；https://www.bright-gene.com/；一图读懂｜博瑞医药2023年度及2024年一季度业绩概况；博瑞医药:2024年4月28日至2024年5月8日投资者调研报告,https://data.eastmoney.com/notices/detail/688166/AN202405101632822542.html等等。本文仅用于向医疗卫生专业人士提供科学信息，不代表平台立场，不作任何用药推荐 08/15 专题一 XDC领域的差异化创新和国际化策略 ◎ 09:00-09:20 XDC偶联药物研发进展及挑战 ◎ 09:20-09:40 ADC药物创新要点及与挑战 ◎ 09:40-10:00 Nectin-4 ADC最新临床研究策略 ◎ 10:00-10:20 双抗ADC早期设计和靶点选择 ◎ 10:20-10:40 新型偶联技术bi-XDC的设计及优势 ◎ 10:40-11:00 XDC药物国际注册策略的思考及实例分享 ◎ 11:00-11:20 偶联药物BD合作与投融资策略 ◎ 11:20-11:40 ADC药物出海之--海外临床开发策略和经验 ◎ 11:40-12:00 偶联药物CMC难点及商业化策略 08/16 专题二核素药物开发专题 ◎ 高通量筛选技术与放射性新药物发现与优化 ◎ 靶向GPC3放射性药物的筛选与开发 ◎ 靶向放射性核素疗法的迭代与升级的展望 ◎ 放射性药物CMC的全面解析 ◎ 临床CRO助力中国放射性新药研发--挑战与应对 ◎ 放射性药物注册策略与实施 ◎ 医用放射性同位素的国产化及其应用 ◎ 从投资角度看待放射性药物赛道 ◎ 临床经验分享：靶向放射性药物对多发转移肿瘤治疗的优势 ◎ 创新核药研发与商业化的新模式与案例解析拟邀嘉宾高长寿信达生物，CSO 刘翠华百奥泰生物高级副总裁刘大涛迈威生物，CEO 吕明尚健生物董事长秦刚启德医药，CEO 唐华东植德律所，合伙人田文志宜明昂科，创始人、董事长兼总经理王春河达石药业，董事长王忠民康方生物，副总裁衣宪华苏州普灵生物，CEO 张富尧弼领生物，董事长&总经理赵永新多禧生物CEO 周清诗健生物，CEO 朱义百利药业，董事长朱永红岸迈生物，CMO 限时扫码报名！版权声明：本文转自生物药大时代，如不希望被转载的媒体或个人可与我们联系，我们将立即删除【关于药融圈】药融圈PRHub旨在帮助生物医药科技型企业进行品牌推广及商务拓展服务，针对客户的真实需求制定系统化解决方案，通过“翻译-降维-场景化”将客户的品牌信息以直白易懂的方式被公众知悉，同时在流量渠道覆盖100万+垂直用户基础上实现合作目的，帮助合作伙伴完成从品牌开始到商务为终的闭环营销服务。我们已经完成了数十场线下1000人规模的生物医药研发类会议，涵盖小分子新药，大分子新药，改良型新药，BD跨境交易等多个领域，服务了百余家上市/独角兽/生物技术/制药企业。

临床3期财报临床1期

2024-06-01

·PRNewswire

Boehringer Ingelheim's COPD and asthma inhalers are now available for $35 a month for eligible patients

Boehringer's first-of-its-kind program automatically reduces the costs of its COPD and asthma inhalers at the pharmacy counter for vast majority of eligible patients Program provides predictable, affordable and consistent costs for as many patients as possible, including uninsured patients and those with high co-pays RIDGEFIELD, Conn., June 1, 2024 /PRNewswire/ -- Boehringer Ingelheim's new program to cap out-of-pocket costs at $35 per month for eligible patientsi for the company's inhalers is now available. With this program, patients who have had difficulty navigating the current healthcare system will now be able to afford the Boehringer inhalers they need. "Ensuring equitable access to life-saving medications is not just a commitment—it's our responsibility," said Jean-Michel Boers, President and CEO, Boehringer Ingelheim USA Corporation. "This program and its $35 cost to patients applies to our entire portfolio of inhalers, making them affordable to all eligible patients, including the most vulnerable patients, such as those who are uninsured or underinsured. While we recognize this is just one solution, we see it as a stepping-stone in our ongoing commitment to ensure the healthcare system is fairer and simpler for all patients." Starting today, the reduced out-of-pocket cost will be automatically applied at participating retail pharmacies for eligible patients with commercial insurance. More than 90% of pharmacies across the country are participating in the program, making the change seamless and automatic for most patients. There are no forms to fill out or websites to go to—the discount happens electronically with no action required. All other eligible patients, including those whose pharmacies do not participate and those without insurance, can visit to enroll for a savings card to present at pharmacies to receive the same $35 cap of out-of-pocket costs. The program applies to all Boehringer Ingelheim inhalers, including: Atrovent® HFA (ipratropium bromide HFA) Inhalation Aerosol Combivent® Respimat® (ipratropium bromide and albuterol) Inhalation Spray Spiriva® HandiHaler® (tiotropium bromide inhalation powder) Spiriva® Respimat® 1.25 mcg (tiotropium bromide) Inhalation Spray Spiriva® Respimat® 2.5 mcg (tiotropium bromide) Inhalation Spray Stiolto® Respimat® (tiotropium bromide and olodaterol) Inhalation Spray Striverdi® Respimat® (olodaterol) Inhalation Spray The program builds on Boehringer's long-standing commitment to supporting patients. The company provides savings cards for most of its products, which help patients meet the co-payments required by their insurance companies. In addition, the company provides medicine for free to eligible patients through the Boehringer Cares Foundation. About Boehringer Ingelheim Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in Research and Development, the company focuses on developing innovative therapies in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. More than 53,500 employees serve over 130 markets to build a healthier, more sustainable, and equitable tomorrow. Learn more at . iTerms and conditions apply. Government restrictions exclude people enrolled in federal government insurance programs from co-pay support. ATROVENT HFA (ipratropium bromide HFA) INHALATION AEROSOL Indication for Use ATROVENT HFA (ipratropium bromide HFA) Inhalation Aerosol is a prescription maintenance treatment for bronchospasm (airway narrowing) in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Important Safety Information Do not use ATROVENT HFA if you are allergic to ipratropium or any of the ingredients in ATROVENT HFA or to atropine or similar drugs. ATROVENT HFA is not a rescue medicine and should not be used for treating sudden breathing problems. Your doctor may give you other medicine to use for sudden breathing problems. Allergic reactions may occur, including itching, swelling of the face, lips, tongue, or throat (involving difficulty in breathing or swallowing), rash, hives, bronchospasm (airway narrowing), or anaphylaxis. Some of these may be serious. If you experience any of these symptoms, stop taking ATROVENT HFA at once and call your doctor or get emergency help. ATROVENT HFA can cause the narrowing of the airways to get worse (paradoxical bronchospasm) which may be life threatening. If this happens, stop taking ATROVENT HFA at once and call your doctor or get emergency help. ATROVENT HFA may increase eye pressure which may cause or worsen some types of glaucoma. Do not get the spray into your eyes. The spray may cause eye pain or discomfort, blurred vision, enlarged pupils, seeing halos or colored images along with red eyes. If you have any of these symptoms, stop taking ATROVENT HFA and call your doctor right away. Dizziness and blurred vision may occur with ATROVENT HFA. Should you experience these symptoms, use caution when engaging in activities such as driving a car or operating appliances or machinery. ATROVENT HFA may cause difficulty with urination. Symptoms may include difficulty passing urine and/or painful urination. If you have any of these symptoms, stop taking ATROVENT HFA and call your doctor right away. The most common side effects reported with use of ATROVENT HFA were bronchitis, COPD flare-up (exacerbation), shortness of breath and headache. Tell your doctor about all medicines you are taking, including eye drops. Ask your doctor if you are taking any anticholinergic medicines because taking them together with ATROVENT HFA can increase side effects. Please see full Prescribing Information including Instructions for Use. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1‑800‑FDA‑1088. (9/16) CL-AT-0017 Combivent Respimat (ipratropium bromide and albuterol) Inhalation Spray Indication for Use COMBIVENT RESPIMAT (ipratropium bromide and albuterol) is indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm (airway narrowing) and who require a second bronchodilator. Important Safety Information Do not use COMBIVENT RESPIMAT if you are allergic to any of the ingredients in COMBIVENT RESPIMAT or to atropine or other similar drugs. COMBIVENT RESPIMAT can cause the narrowing of the airways to get worse (paradoxical bronchospasm) which may be life threatening. If this happens, stop taking COMBIVENT RESPIMAT at once and call your doctor or get emergency help. COMBIVENT RESPIMAT can cause serious heart-related side effects, such as palpitations, chest pain, rapid heart rate, high blood pressure, tremor, or nervousness. Call your doctor if you experience any of these symptoms. Avoid spraying COMBIVENT RESPIMAT into your eyes. COMBIVENT RESPIMAT may increase eye pressure which may cause or worsen some types of glaucoma. If you have sudden vision changes, eye pain or visual halos, stop taking COMBIVENT RESPIMAT and call your doctor right away. COMBIVENT RESPIMAT may cause difficulty with urination. Dizziness and blurred vision may occur with COMBIVENT RESPIMAT. Should you experience these symptoms, use caution when engaging in activities such as driving a car or operating appliances or other machines. Do not use COMBIVENT RESPIMAT more often than your doctor has directed. Deaths have been reported with similar inhaled medicines in asthma patients who use the medicine too much. Seek medical attention if your treatment with COMBIVENT RESPIMAT becomes less effective for symptomatic relief, your symptoms become worse, and/or you need to use the product more frequently than usual. Allergic reactions may occur, including itching, swelling of the face, lips, tongue, or throat (involving difficulty in breathing or swallowing), rash, hives, bronchospasm (airway narrowing), or anaphylaxis. Some of these may be serious. If you experience any of these symptoms, stop taking COMBIVENT RESPIMAT at once and call your doctor or get emergency help. Tell your doctor about all your medical conditions, especially if you have narrow-angle glaucoma, prostate or urinary problems, a history of heart conditions (such as irregular heartbeat, high blood pressure), thyroid disorder, or diabetes. Also tell your doctor if you are pregnant or nursing. Tell your doctor about all medicines you are taking, especially heart medications or drugs to treat depression. The most common side effects reported with use of COMBIVENT RESPIMAT include infection of the ears, nose, and throat, runny nose, cough, bronchitis, headache, and shortness of breath. Click here for full Prescribing Information and Patient Instructions for Use. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. CL-CBR-100003 10.31.2018 SPIRIVA RESPIMAT (tiotropium bromide) Inhalation Spray and SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) Indications SPIRIVA RESPIMAT, 2.5 mcg, and SPIRIVA HANDIHALER are long-term, once-daily, prescription maintenance medicines used to control symptoms of chronic obstructive pulmonary disease (COPD) by relaxing your airways and keeping them open. COPD includes chronic bronchitis and emphysema. SPIRIVA RESPIMAT and SPIRIVA HANDIHALER also reduce the likelihood of flare-ups (COPD exacerbations). SPIRIVA RESPIMAT, 1.25 mcg, is a long-term, once-daily, prescription maintenance treatment of asthma for people 6 years and older. SPIRIVA is not a treatment for sudden symptoms of asthma or COPD. Important Safety Information for SPIRIVA RESPIMAT Do not use SPIRIVA RESPIMAT or SPIRIVA HANDIHALER if you are allergic to tiotropium, ipratropium, atropine or similar drugs, or any ingredient in these medicines. SPIRIVA RESPIMAT or SPIRIVA HANDIHALER are not rescue medicines and should not be used for treating sudden breathing problems. Your doctor may give you other medicine to use for sudden breathing problems. SPIRIVA RESPIMAT or SPIRIVA HANDIHALER can cause allergic reactions. Symptoms can include raised red patches on your skin (hives), itching, rash and/or swelling of the lips, tongue, or throat that may cause difficulty in breathing or swallowing. If you have any of these symptoms, stop taking the medicine and seek emergency medical care. Before using SPIRIVA HANDIHALER, tell your doctor if you have a severe allergy to milk proteins. SPIRIVA RESPIMAT or SPIRIVA HANDIHALER can cause your breathing to suddenly get worse (bronchospasm). If this happens, use your rescue inhaler, stop taking SPIRIVA, and call your doctor right away or seek emergency medical care. SPIRIVA RESPIMAT or SPIRIVA HANDIHALER can increase the pressure in your eyes (acute narrow-angle glaucoma) which can cause the following symptoms: eye pain, blurred vision, seeing halos or colored images along with red eyes. If you have any of these symptoms, stop taking your medicine and call your doctor right away. Dizziness and blurred vision may occur with SPIRIVA RESPIMAT or SPIRIVA HANDIHALER. If you experience these symptoms, use caution when engaging in activities such as driving a car, or operating appliances or machinery. SPIRIVA RESPIMAT or SPIRIVA HANDIHALER can cause new or worsened urinary retention. Symptoms of blockage in your bladder and/or enlarged prostate may include difficulty passing urine and/or painful urination. If you have any of these symptoms, stop taking your medicine and call your doctor right away. The most common side effects reported with SPIRIVA RESPIMAT in patients with COPD include sore throat, cough, dry mouth, and sinus infection. The most common side effects with SPIRIVA RESPIMAT in adult patients with asthma were sore throat, headache, bronchitis, and sinus infection. The side effect profile for adolescent and pediatric patients was comparable to that observed in adult patients with asthma. The most common side effects reported with SPIRIVA HANDIHALER in patients with COPD include upper respiratory tract infection, dry mouth, sinus infection, sore throat, non-specific chest pain, urinary tract infection, indigestion, runny nose, constipation, increased heart rate, and blurred vision. Do not swallow SPIRIVA capsules. The contents of the capsule should only be inhaled through your mouth using the HANDIHALER device. Do not spray SPIRIVA RESPIMAT into your eyes, as this may cause blurring of vision and pupil dilation. Tell your doctor about all your medical conditions including kidney problems, glaucoma, enlarged prostate, problems passing urine, or blockage in your bladder. Tell your doctor all the medicines you take, including eye drops. Ask your doctor if you are taking any anticholinergic medicines because taking them together with SPIRIVA can increase side effects. Do not use SPIRIVA RESPIMAT and SPIRIVA HANDIHALER together. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Click here for full Prescribing Information and Patient Instructions for Use for SPIRIVA RESPIMAT. Click here for full Prescribing Information and Patient Instructions for Use for SPIRIVA HANDIHALER. CL-SVR-0048 2.15.2017 STIOLTO RESPIMAT (tiotropium bromide and olodaterol) Inhalation Spray APPROVED USE FOR STIOLTO RESPIMAT STIOLTO® RESPIMAT® (tiotropium bromide and olodaterol) Inhalation Spray is a prescription medicine used long term, 2 puffs 1 time each day, in controlling symptoms in adults with chronic obstructive pulmonary disease (COPD). COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both. STIOLTO is not for treating sudden symptoms of COPD. Always have a rescue medicine with you to treat sudden symptoms. STIOLTO is not for asthma. Important Safety Information for STIOLTO RESPIMAT Do not use STIOLTO if you have asthma. People with asthma who take long-acting beta2-agonist (LABA) medicines, such as olodaterol, (one of the medicines in STIOLTO), without also using a medicine called an inhaled corticosteroid, have an increased risk of serious problems from asthma, including being hospitalized, needing a tube placed in their airway to help them breathe, or death. Do not use STIOLTO if you are allergic to tiotropium, ipratropium, atropine or similar drugs, olodaterol, or any ingredient in STIOLTO. Call your healthcare provider or get emergency medical care if you experience symptoms of a serious allergic reaction including: rash, hives, itching, swelling of the face, lips, tongue, throat, and difficulties in breathing or swallowing. Get emergency medical care if your breathing problems worsen quickly or if you use your rescue inhaler but it does not relieve your breathing problems. Call your healthcare provider if breathing problems worsen over time while using STIOLTO. Do not use STIOLTO more often than prescribed by your doctor. Do not use STIOLTO with other LABAs or anticholinergics. Do not use STIOLTO for treating sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms. Tell your doctor about all your medical conditions including heart problems, high blood pressure, seizures, thyroid problems, diabetes, kidney problems, glaucoma, enlarged prostate, and problems passing urine. STIOLTO can cause serious side effects, including sudden shortness of breath that may be life threatening, fast or irregular heartbeat, increased blood pressure, chest pain, tremor, headache, nervousness, high blood sugar, or low blood potassium that may cause muscle weakness or abnormal heart rhythm. If any of these happens, stop taking STIOLTO and seek immediate medical help. STIOLTO can cause new or worsening eye problems including narrow-angle glaucoma, and can increase the pressure in your eyes, which can cause the following symptoms: eye pain, blurred vision, seeing halos or colored images along with red eyes. If you have any of these symptoms, stop taking STIOLTO and call your doctor right away. STIOLTO can cause new or worsened urinary retention. Symptoms of urinary retention may include difficulty passing urine, painful urination, urinating frequently, or urinating in a weak stream or drips. If you have any of these symptoms, stop taking STIOLTO and call your doctor right away. The most common side effects of STIOLTO are runny nose, cough, and back pain. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, eye drops, vitamins, and herbal supplements. STIOLTO and certain other medicines may affect each other. STIOLTO is for oral inhalation only. The STIOLTO cartridge is only intended for use with the STIOLTO RESPIMAT inhaler. Do not spray STIOLTO into your eyes. Your vision may become blurred and your pupils may become larger (dilated). You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Read the step-by-step patient Instructions for Use for STIOLTO RESPIMAT before you use your inhaler. Please see accompanying full Prescribing Information, Patient Information, and Instructions for Use for STIOLTO RESPIMAT. CL-STO-100022 6.5.2019 STRIVERDI® RESPIMAT® (olodaterol) Inhalation Spray APPROVED USE for STRIVERDI RESPIMAT Striverdi® Respimat® (olodaterol) Inhalation Spray is a prescription medicine used long term, 2 puffs, 1 time each day, in controlling symptoms in adults with chronic obstructive pulmonary disease (COPD). COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both. STRIVERDI RESPIMAT is not for treating sudden symptoms of COPD. Always have a rescue medicine with you to treat sudden symptoms. Striverdi is not for asthma. Important Safety Information for STRIVERDI RESPIMAT Do not use STRIVERDI if you have asthma. People with asthma who take long‐acting beta2‐agonist (LABA) medicines, such as STRIVERDI RESPIMAT, without also using a medicine called an inhaled corticosteroid (ICS), have an increased risk of serious problems from asthma, including being hospitalized, needing a tube placed in their airway to help them breathe, or death. Get emergency medical care if your breathing problems worsen quickly or you use your rescue medicine but it does not relieve your breathing problems. Call your healthcare provider if breathing problems worsen over time while using STRIVERDI. Do not use STRIVERDI RESPIMAT more often than prescribed for you by your doctor. Do not use STRIVERDI RESPIMAT with other LABAs. Do not use STRIVERDI for treating sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms. Tell your doctor about all of your medical conditions, including heart problems, high blood pressure, seizures, thyroid problems, and diabetes. STRIVERDI RESPIMAT can cause serious side effects including sudden shortness of breath that may be life threatening, fast or irregular heartbeat, increased blood pressure, chest pain, tremor, headache, nervousness, high blood sugar, or low blood potassium that may cause muscle weakness or abnormal heart rhythm. If any of these happen, stop taking STRIVERDI and seek immediate medical help. Call your healthcare provider or get emergency medical care if you get any symptoms of a serious allergic reaction including: rash, hives, itching, swelling of the face, lips, tongue, throat, and difficulties in breathing or swallowing. The most common side effects are runny nose, sore throat, upper respiratory tract infection, bronchitis, urinary tract infection, cough, dizziness, rash, diarrhea, back pain, and joint pain. Tell your doctor about all the medicines you take, including prescription and non‐prescription medicines, vitamins, and herbal supplements. STRIVERDI and certain other medicines may affect each other. STRIVERDI is for oral inhalation only. The STRIVERDI cartridge is only intended for use with the STRIVERDI RESPIMAT inhaler. Do not spray STRIVERDI into your eyes. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1 ‐ 800 ‐ FDA ‐ 1088. Read the step-by-step patient Instructions for Use for STRIVERDI RESPIMAT before you use your inhaler. Please see accompanying full Prescribing Information, including Patient Information, and Instructions for Use for STRIVERDI RESPIMAT. CL-STRR-100001 6.5.2019 Media Contact Michele Baer Human Pharma Communications [email protected] Boehringer Ingelheim 900 Ridgebury Road Ridgefield CT 06877 More information boehringer-ingelheim.com/us ISC-MPR-US 103150 - 05/24 SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.

上市批准

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	R03A	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
慢性支气管炎	日本	Nippon Boehringer Ingelheim Co., Ltd.	2015-11-18
肺气肿	日本	Nippon Boehringer Ingelheim Co., Ltd.	2015-11-18
慢性阻塞性肺疾病	美国	Boehringer Ingelheim Pharmaceuticals, Inc.	2015-05-21

未上市

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适应症	最高研发状态	国家/地区	公司	日期
慢性肺疾病	临床3期	美国	Boehringer Ingelheim GmbH	2014-03-01
慢性肺疾病	临床3期	澳大利亚	Boehringer Ingelheim GmbH	2014-03-01
慢性肺疾病	临床3期	奥地利	Boehringer Ingelheim GmbH	2014-03-01
慢性肺疾病	临床3期	比利时	Boehringer Ingelheim GmbH	2014-03-01
慢性肺疾病	临床3期	加拿大	Boehringer Ingelheim GmbH	2014-03-01
慢性肺疾病	临床3期	丹麦	Boehringer Ingelheim GmbH	2014-03-01
慢性肺疾病	临床3期	德国	Boehringer Ingelheim GmbH	2014-03-01
慢性肺疾病	临床3期	新西兰	Boehringer Ingelheim GmbH	2014-03-01
慢性肺疾病	临床3期	波兰	Boehringer Ingelheim GmbH	2014-03-01
慢性肺疾病	临床3期	葡萄牙	Boehringer Ingelheim GmbH	2014-03-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05127304 (Pubmed \| J Manag Care Spec Pharm)	N/A	慢性阻塞性肺疾病	-	Tiotropium/Olodaterol (TIO + OLO)	壓壓範繭網積鹹壓顧膚(繭製壓醖鑰鹽齋鏇鏇願) = 壓艱積鑰顧糧範窪願積構夢鑰襯艱鹽齋糧鹹顧 (獵餘襯積艱鹽願憲鏇選, 0.86 ~ 1.0)	-	2023-07-01
NCT02850978 (Pubmed \| Adv Ther)	N/A	气肿 \| 慢性支气管炎	1,255	Tiotropium/Olodaterol	廠壓願顧壓襯獵齋蓋壓(鹽醖築鏇鹹餘製憲艱艱) = 艱繭簾觸構製餘鏇築構艱鑰選願餘糧製築膚顧 (積築糧衊顧積艱選鹹遞 ) 更多	-	2022-08-10
NCT02845752 (Pubmed \| J Appl Physiol (1985))	临床4期	慢性阻塞性肺疾病	14	Tiotropium-olodaterol	鹽簾憲簾膚獵製憲窪鑰(製夢製簾構獵範鬱夢夢) = 艱淵膚膚積顧網網製範蓋衊餘積鬱遞鬱餘築艱 (艱廠簾構觸範憲窪鹹觸 )	不佳	2022-03-24
				Placebo	鹽簾憲簾膚獵製憲窪鑰(製夢製簾構獵範鬱夢夢) = 製獵壓顧艱壓夢廠餘淵蓋衊餘積鬱遞鬱餘築艱 (艱廠簾構觸範憲窪鹹觸 )
NCT03265145 (CTgov)	临床4期	慢性阻塞性肺疾病	714	LABA (Long-Acting Beta Agonist) (Triple therapy)	壓艱鹹窪膚鹹蓋窪壓夢(鑰觸製簾範窪夢鬱願選) = 齋艱遞醖築艱鬱壓鏇壓淵鬱襯製獵艱糧糧鹽積 (構衊製艱蓋憲範憲憲壓, 築構艱鏇淵願選蓋糧鬱 ~ 築鹹窪鏇鹽製糧憲願壓) 更多	-	2021-12-09
NCT04223843 (CTgov)	临床4期	慢性阻塞性肺疾病	213	Olo+Tio (Tio+Olo (5μg/5μg) - Sub-optimal PIFR)	壓壓壓鏇衊鏇夢壓夢窪(鑰獵鏇構觸糧蓋鏇簾艱) = 製鬱製醖醖衊鬱淵鑰襯鏇鹹憲衊遞顧齋衊製鏇 (積壓窪憲鏇鏇範膚餘膚, 0.033) 更多	-	2021-11-18
				Placebo (Matching Placebo - Sub-optimal PIFR)	壓壓壓鏇衊鏇夢壓夢窪(鑰獵鏇構觸糧蓋鏇簾艱) = 築淵蓋鹽糧壓遞壓糧鏇鏇鹹憲衊遞顧齋衊製鏇 (積壓窪憲鏇鏇範膚餘膚, 0.031) 更多
NCT03165045 (AERIAL, Pubmed \| ERJ Open Res)	N/A	慢性阻塞性肺疾病	1,322	Tiotropium/olodaterol	憲襯範願構觸齋衊顧鹹(淵鑰選簾淵鏇窪積鹽願) = 網網窪範選築觸築廠窪夢獵衊選製範鏇範襯範 (積膚簾醖網淵醖艱餘餘 ) 更多	-	2021-07-01
NCT04138758 (Pubmed \| Adv Ther)	N/A	慢性阻塞性肺疾病维持	42,953	Tiotropium/olodaterol	簾膚窪簾顧構壓鹹鏇選(網齋獵窪簾築廠顧蓋願): adjusted hazard ratio = 0.76 (95% CI, 0.68 ~ 0.85) 更多	积极	2021-03-15
				LABA/ICS
NCT01431287 \| NCT01431274 (TONADO, Pubmed \| Adv Ther)	临床3期	慢性阻塞性肺疾病	2,055	Tiotropium/olodaterol 5/5 μg	鏇襯簾構鏇糧簾醖艱構(願窪壓積鬱鑰鏇衊鑰鏇): HR = 0.76 (95% CI, 0.68 ~ 0.85)	积极	2021-01-01
				Tiotropium 5 μg
ERS2020	N/A	慢性阻塞性肺疾病	80	Tiotropium	鹽壓選窪鹽糧窪顧鑰範(蓋築顧鹹淵醖襯繭艱糧) = 憲窪窪觸襯蓋積艱衊鑰築蓋齋遞獵築觸觸窪顧 (製蓋憲構窪憲蓋糧餘餘 ) 更多	-	2020-09-07
				Tiotropium/Olodaterol	鹽壓選窪鹽糧窪顧鑰範(蓋築顧鹹淵醖襯繭艱糧) = 範選淵繭襯廠網鹹鏇遞築蓋齋遞獵築觸觸窪顧 (製蓋憲構窪憲蓋糧餘餘 ) 更多
NCT02006732 \| NCT01964352 \| NCT01431287 \| NCT01431274 (TONADO® and OTEMTO®, Pubmed \| Adv Ther)	N/A	慢性阻塞性肺疾病	-	Tiotropium	餘鏇鏇膚艱構艱網淵鬱(構醖築築憲獵選襯積醖) = 襯艱鑰鑰鹹餘鹽壓顧夢醖憲鹽網構鹹膚壓選鏇 (鏇製簾範願襯窪蓋鑰簾, 0.033 ~ 0.115)	-	2020-08-01