The purpose of the project is to investigate exercise performance in humans following prolonged inhalation of beta2-agonists vilanterol + fluticasone furoate or indacaterol + mometasone furoate

开始日期2023-10-05

申办/合作机构

University of Copenhagen

CTR20213115 / Completed临床3期

马来酸茚达特罗吸入粉雾剂人体生物等效性试验

主要研究目的：本试验以深圳市海滨制药有限公司生产的马来酸茚达特罗吸入粉雾剂为受试制剂，以诺华公司生产的马来酸茚达特罗吸入粉雾剂（商品名：昂润®）为参比制剂，比较受试制剂和参比制剂在慢性阻塞性肺疾病（COPD）受试者体内的药效动力学，评价两者单次吸入给药的生物等效性；次要研究目的：考察受试制剂和参比制剂在COPD受试者中的安全性。

开始日期2021-12-07

申办/合作机构

深圳市海滨制药有限公司

[+1]

NCT04856098 / Completed临床1期

A Pharmacokinetic Feasibility Study on Ultibro Breezhaler, an Indacaterol-glycopyrronium Inhalation Powder Capsule, in Healthy Subjects

The objective of this study is to assess pharmacokinetics (PK) of indacaterol and glycopyrronium, and methodology and practical arrangements for future studies.

开始日期2021-05-07

申办/合作机构

Orion Corp

100 项与马来酸茚达特罗相关的临床结果

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100 项与马来酸茚达特罗相关的转化医学

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100 项与马来酸茚达特罗相关的专利（医药）

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项与马来酸茚达特罗相关的文献（医药）

2024-09-01·The Journal of asthma : official journal of the Association for the Care of Asthma

Digitally monitored inhaled therapy: a ‘smart’ way to manage severe asthma?

Article

作者: Faruqi, Shoaib ; Overton, Kylie ; Thompson, Joanne ; Watkins, Karen ; Cummings, Helena ; Sykes, Dominic L ; Chow, Evon C Y ; See, Yee Yong ; Riches, Charlotte ; Crooks, Michael G ; Robinson, Mandy

INTRODUCTION:

One of the fundamental challenges of managing patients with severe asthma is treatment adherence, particularly with inhaled corticosteroids. Adherence is difficult to measure objectively and poor adherence is associated with worse outcomes. In this study, assess the ability of a 'smart' inhaler to record adherence in severe asthma patients and measure the impact of this on asthma control.

METHODS:

Consecutive consenting patients meeting criteria for biologics had their existing high-dose ICS/LABA//LAMA combination inhaler/s switched to mometasone/indacaterol/glycopyrronium (114/46/136). Routine clinical data, including blood eosinophils, FeNO, and ACQ-6 scores were collected at baseline and at 4 wk. Adherence was then checked on the Propeller Health app, and good adherence was defined as >80% of prescribed usage. Participants were then followed-up at 12 months to record the proportion of patients who were initiated on biologics.

RESULTS:

77 patients (mean [SD] age = 50.4 [15.7] years, 67.5% female [n = 52]) participated. 71 participants were able to use the device and 65% (n = 46) of these attained good asthma control and were not initiated on biologics at 12-month follow-up. Both groups demonstrated a significant reduction in ACQ6 score at follow-up (2.81 vs. 1.92, p < 0.001 and 3.05 vs. 2.60, p < 0.001, respectively), but there was no statistically significant difference in improvement between groups. Patients with optimal adherence also demonstrated a significant reduction in median FeNO at follow-up (47 ppb vs. 40 ppb, p = 0.003).

CONCLUSIONS:

In severe asthma patients, 'smart' inhalers may represent an effective management tool to improve adherence and asthma control, therefore avoiding the need for patients to commence biological therapies.

2024-08-28·JOURNAL OF NEUROSCIENCE

Calmodulin Triggers Activity-Dependent rRNA Biogenesis via Interaction with DDX21

Article

作者: Yang, Jia-Lin ; Sun, Xue ; Zhao, Wei-Dong ; Sun, Hong-Zan ; Wang, Kai-Tuo ; Shi, Jun-Xiu ; An, Ming-Xin ; Yang, Yong-Liang ; Cao, Xin-Yu ; Wu, Si-Jin ; Cui, Qing-Xu

Protein synthesis in response to neuronal activity, known as activity-dependent translation, is critical for synaptic plasticity and memory formation. However, the signaling cascades that couple neuronal activity to the translational events remain elusive. In this study, we identified the role of calmodulin (CaM), a conserved Ca2+-binding protein, in ribosomal RNA (rRNA) biogenesis in neurons. We found the CaM-regulated rRNA synthesis is Ca2+-dependent and necessary for nascent protein synthesis and axon growth in hippocampal neurons. Mechanistically, CaM interacts with nucleolar DEAD (Asp–Glu–Ala–Asp) box RNA helicase (DDX21) in a Ca2+-dependent manner to regulate nascent rRNA transcription within nucleoli. We further found CaM alters the conformation of DDX21 to liberate the DDX21-sequestered RPA194, the catalytic subunit of RNA polymerase I, to facilitate transcription of ribosomal DNA. Using high-throughput screening, we identified the small molecules batefenterol and indacaterol that attenuate the CaM-DDX21 interaction and suppress nascent rRNA synthesis and axon growth in hippocampal neurons. These results unveiled the previously unrecognized role of CaM as a messenger to link the activity-induced Ca2+influx to the nucleolar events essential for protein synthesis. We thus identified the ability of CaM to transmit information to the nucleoli of neurons in response to stimulation.

2024-07-01·Respiratory Investigation

Real-world characteristics of patients with asthma initiating fluticasone furoate/umeclidinium/vilanterol single-inhaler triple therapy in Japan

Article

作者: Yarita, Masao ; Yuanita, Liza ; Oga, Toru ; Ito, Risako ; Requena, Gema ; Noorduyn, Stephen G ; Mita, Chifuku ; Rothnie, Kieran J

BACKGROUND:

Real-world data assessing characteristics of patients with asthma initiating inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β₂-agonist (ICS/LAMA/LABA) triple therapy in Japan are limited.

METHODS:

Descriptive, observational study of patients with asthma aged ≥15 years newly initiating single- or multiple-inhaler triple therapy (SITT: fluticasone furoate/umeclidinium/vilanterol [FF/UMEC/VI], SITT: indacaterol/glycopyrronium bromide/mometasone furoate [IND/GLY/MF] or MITT) or ICS/LABA using JMDC/Medical Data Vision (MDV) health insurance databases from February 2021-February 2022 (first prescription date: index date). Patients were assigned to three non-mutually exclusive cohorts: A) new FF/UMEC/VI initiators; B) new FF/UMEC/VI, IND/GLY/MF, or MITT initiators; C) new FF/UMEC/VI, IND/GLY/MF, MITT or ICS/LABA initiators as initial maintenance therapy (IMT). Patient characteristics were assessed descriptively for 12-months pre-treatment initiation (baseline period).

RESULTS:

Cohort A: among new FF/UMEC/VI initiators, 12.8% and 0.1% (JMDC) and 21.7% and 0.9% (MDV) of patients had ≥1 moderate and severe exacerbation; 52.0% (JMDC) and 79.2% (MDV) had ICS/LABA use. Cohort B: most patients initiated FF/UMEC/VI and IND/GLY/MF over MITT (JMDC: 91.3% vs 8.7%; MDV: 67.8% vs 32.2%), with fewer exacerbations and lower rescue medication use. Cohort C: a greater proportion of FF/UMEC/VI initiators as IMT experienced a moderate exacerbation at index versus ICS/LABA initiators as IMT (JMDC: 17.8% vs 10.7%; MDV: 8.0% vs 5.1%).

CONCLUSIONS:

Patient characteristics were generally similar between treatment groups; SITT initiators had fewer exacerbations and lower rescue medication use than MITT initiators, represented by the greater proportion of IMT among SITT versus MITT initiators. Physicians may have prescribed triple over dual therapy as IMT in response to an exacerbation.

项与马来酸茚达特罗相关的新闻（医药）

2024-05-01

·BioSpace

FTC Targets ‘Junk’ Patents Including Novo’s Ozempic, GSK’s Trelegy Ellipta and Other Drugs

Pictured: Entrance to the FTC's office in Washington, DC/iStock, hapabapa The U.S. Federal Trade Commission on Tuesday sent warning letters to 10 pharmaceutical companies, challenging patents for several drugs including Novo Nordisk’s blockbuster diabetes treatment Ozempic (semaglutide) and GSK’s asthma inhaler Trelegy Ellipta (fluticasone, umeclidinium, vilanterol). The FTC is challenging the patents of 20 different brand name products, claiming that their listings in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations—more commonly known as the Orange Book—are improper or inaccurate. “By filing bogus patent listings, pharma companies block competition and inflate the cost of prescription drugs, forcing Americans to pay sky-high prices for medicines they rely on,” FTC Chair Lina Khan said in a statement. “By challenging junk patent filings, the FTC is fighting these illegal tactics and making sure that Americans can get timely access to innovative and affordable versions of the medicines they need,” Khan added. In addition to Ozempic and Trelegy Ellipta, the FTC’s latest round of patent challenges also targets Novo’s Saxenda (liraglutide) and Victoza (liraglutide)—both indicated for type 2 diabetes—and Novartis’ inhaler products Seebri Breezhaler (glycopyrronium bromide) and Utibron Neohaler (indacaterol and glycopyrrolate), approved for chronic obstructive pulmonary disease. The pharma companies now have 30 days to either withdraw or amend their disputed listings, or confirm “under penalty or perjury” that these patents indeed comply with the statutory and regulatory requirements. A GSK spokesperson in a statement to Endpoints News said that the company is reviewing the FTC’s letter. GSK takes “the FTC’s views seriously; however, we will also do our own analysis as the law requires. Once complete, we will respond to the FDA and FTC.” Meanwhile, a Boehringer Ingelheim spokesperson said that the pharma “has never wrongfully submitted patents for listing in the Orange Book.” Tuesday’s warnings follow an initial salvo in November 2023, when the FTC challenged more than 100 patents by 10 pharma companies including AbbVie, AstraZeneca and subsidiaries of GSK and Teva Pharmaceuticals. At the time, the antitrust watchdog targeted a wide range of pharmaceutical products, including inhaler devices, multidose bottles and epinephrine autoinjectors. Aside from the FTC, members of Congress have also started targeting the high cost of medication in the U.S., paying particular attention to Ozempic. Last week, Sen. Bernie Sanders (I-Vt.), chair of the Senate health committee, launched a probe into the ‘outrageously high prices’ of Ozempic, as well as its sister weight-loss therapy Wegovy (semaglutide). Sanders in a letter to Novo CEO Lars Fruergaard Jørgensen asked for additional information regarding Ozempic and Wegovy, including revenue, prices paid by public and private payers, R&D spending and the pharma’s tactics to extend their exclusivity. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

专利到期

2023-10-13

·动脉网

诺奖得主担任科学顾问，IPO募资超6000万美元，这家企业如何创新肺部疾病吸入制剂？

近日，备受瞩目的2023年诺贝尔生理学或医学奖获奖名单揭晓，获得者是美国科学家卡塔林·卡里科（Katalin Karikó）和德鲁·魏斯曼（Drew Weissman）。他们因核苷碱基修饰方面的发现而获奖，这些发现最终推动了COVID-19 mRNA 疫苗的成功研发。两位科学家并不局限于科研成果的突破，也在科学成果转发和技术落地方面有着突出贡献。Katalin Karikó曾在BioNTech担任副总裁与高级副总裁，强力推动了公司mRNA疫苗的研发。Drew Weissman则在2006年与Katalin Karikó共同成立了RNAX公司，并作为科学创始人成立了基因编辑明星公司Beam Therapeutics、细胞疗法公司Capstan Therapeutics，同时也在多家企业担任科学顾问，其中就包括生物制药企业TFF Pharmaceuticals（TFFP）。TFFP于2018年成立，现总部位于美国德克萨斯州奥斯汀。公司专注于研发治疗肺部疾病的新型吸入制剂，以改变药物给药方式，从而实现将药物直接递送至目标部位的目的，最终提高药物疗效和安全性。2019年，TFFP在美国纳斯达克成功IPO。在IPO后的6轮融资中，它筹集到了超过6000万美元资金，投资者包括美国国家过敏和传染病研究所、Leidos和Liquid Venture Partners, LLC。Drew Weissman是TFFP科学顾问委员会的成员之一。他的加入，推动了TFFP研发管线的发展。独创TFF技术研发吸入型干粉制剂，药物递送率达75%许多药物由于物理性质较差而不能完全达到作用目标，导致其生物利用度受损，进而带来起效缓慢、疗效不佳等负面影响。液体制剂和粉末制剂是目前常用的制剂类型。液体制剂服用方便，可内服或外用，但它往往药物分散度大，同时受分散介质的影响，化学稳定性较差，药物易分解失效。此外，水溶性差的药物常以大剂量给药，这增加了液体制剂药物毒性和副作用发生的风险。2010年，Thorsteinn Loftsson和Marcus E Brewster两人所做的研究显示，根据生物制药分类系统（BCS）的定义，目前约40%的上市药物和约90%的在研药物由难溶性分子组成1。这意味着，将近一半的药物水溶性差。同时，一些上市药物存在溶解度差、渗透性低、体内代谢和消除快、安全性和耐受性低等问题。与液体制剂不同的是，粉末制剂则具有更强的稳定性、适用性和便携性，并且，粉末还具有改善药物在肺部输送的气溶胶特性。因此，吸入制剂成为多家企业的重点研究方向。吸入制剂包括药与装置，一种或一种以上的药物溶解或分散在合适介质中，经过特殊的给药装置，以蒸汽或气溶胶的形式递送至目标部位，进而发挥局部或全身治疗的作用。为了能够在吸入制剂领域占据一席之地，TFFP独创了Thin Film Freezing（TFF）技术，聚焦干粉吸入制剂领域。这项技术最初由德克萨斯大学奥斯汀分校研发，后独家授权给TFFP。目前，TFF技术获得了美国和欧洲多项专利。TFF技术是一种新型低温技术，它能够改变小分子、生物制剂和联合药物疗法的递送方式，让药物“安全”地输送到身体的不同部位，从而提高药物药效和患者依从性，并降低副作用。TFF技术可以将药物转变为具有低堆积密度、高表面积和非晶或纳米晶体形态的脆性基质颗粒。在此状态下，药物能够保持其结构、活性和功能，以及热稳定性和气溶胶特性。这些脆性基质颗粒经过精加工后，即可得到吸入型干粉制剂。使用TFF技术研发吸入型干粉制剂包含以下四个步骤：1. 混合。首先将药物和溶解制剂混合。溶解制剂中包括促进药物分散的试剂和促进药物递送至目标部位的赋形剂。2. 冷冻。将药物混合制剂放入低温滚筒并对其进行冷冻。随后，药物制剂即可变为高度多孔、大表面积、低密度的脆性基质颗粒。3. 干燥。对脆性基质颗粒进行升华，以除去其中的冷冻溶剂。最后，可得到纯药物颗粒。4. 精加工。对药物颗粒进行进一步加工，最终得到直接吸入型干粉制剂。在这个过程中，TFF技术不会引入热量、剪切应力（内力）或其他可能破坏药物成分的力，而是将药物混合制剂重新配制为易于储存且稳定的干粉制剂。TFFP官网公布的数据显示，TFF技术能够将水溶性差的药物转化为由超95%活性药物组成的吸入型干粉制剂。此外，TFFP的临床数据也表明，脆性基质颗粒的空气动力学特性可以使约75%的药物剂量沉积到目标器官。这意味着，可以按患者所需剂量精确给药，以减少因剂量过高产生的毒副作用。最终，药物的药代动力学效应和安全性将得到增强除此之外，TFF技术将改变药物的运输和储存方式。目前，大部分药物需要冷链运输以保持其活性，运输成本和储存成本极高。而TFF技术可将大分子、小分子、疫苗等药物转化为干粉制剂，在室温条件下，药物的活性和结构将保持稳定。因此，药物的储存和运输的成本将降低，药物的销售范围也将进一步扩大。获FDA孤儿药资格认定，在研管线进入临床2期试验阶段在TFF技术支持下，目前TFFP开发了2条主要管线，分别是TFF VORI和TFF TAC。● TFF VORI：TFF VORI是TFFP在研的新一代肺部吸入式伏立康唑干粉制剂，用于治疗侵袭性肺曲霉病（IPA）等肺部真菌感染类疾病。伏立康唑是IPA的一线治疗药物。但静脉注射或口服伏立康唑会给患者带来严重的副作用，如视觉障碍、肝炎、突发性肝衰竭等，甚至导致死亡。因此，需要严格控制其使用剂量。与IPA传统给药方式不同，患者可通过使用干粉吸入器服用TFF VORI，TFF VORI将直接被递送至肺部感染部位。在治疗过程中，TFF VORI每次给药剂量小，且不会扩散到身体其他部位，生物利用度高。因此，TFF VORI降低了伏立康唑全身扩散及其药物相互作用的风险。TFFP的TFF VOR一期临床试验研究数据表明，患者每天两次直接肺部吸入40毫克剂量的TFF VOR，同时，配合使用雾化器服用静脉注射溶液。持续7天后，患者IPA感染被清除，且未出现任何副作用。今年7月31日，TFFP和制药与医疗技术服务商Uniphar Durbin Ireland Limited宣布启动扩大准入计划（EAP），在美国、澳大利亚、英国、加拿大和部分欧洲国家的IPA患者也将获得TFF-VORI治疗。目前，TFF VORI处于临床2期试验评估阶段。● TFF TAC：TFF TAC是TFFP在研的他克莫司干粉吸入制剂，用于肺移植患者的免疫抑制治疗及排斥反应预防。他克莫司是目前实体器官移植中常用的免疫抑制药物。但由于它是一种强效药物，长期使用会产生不良反应，同时会增加患者肾脏问题发生、抵抗感染力降低等风险。因此，“用低剂量他克莫司实现患者高疗效”成为当下急需解决的问题。TFFP改良了他克莫司制剂，通过干粉吸入器给药，其研发的TFF TAC能够直接被递送到患者肺部。临床数据显示，与口服他克莫司相比，TFF TAC肺部沉积率更高。这意味着，低剂量他克莫司将会带来更高的疗效，从而降低了药物全身扩散和副作用产生的风险。此前，TFF在一期临床试验中成功完成了四组健康受试者的单次和多次递增给药。该阶段的临床数据显示，TFF TAC耐受性良好，没有临床上药物相关不良事件出现。并且，低剂量的TFF TAC（0.5-1.0 mg）能够提高患者全身血液浓度，使其达到足以有效抑制免疫的血液浓度水平。优异的疗效，使TFF TAC在2020年6月获得了FDA孤儿药资格认定，以用于预防肺同种异体移植排斥反应。目前，TFF TAC已经进入二期临床试验阶段。积极推进BD业务，与多方达成战略合作除了推进两条管线的研发外，TFFP还与药企、科研机构、政府机构以及CDMO企业展开了战略合作。2022年3月，TFFP和Catalent达成合作。根据协议，TFFP将为Catalent提供TFF技术，以促进其生产用于吸入给药的生物干粉制剂，其合作企业将可以选择更好的药物递送方式。同时，TFFP还与免疫疗法研发企业Augmenta Bioworks就COVID-19单克隆抗体疗法（AUG-3387）达成全球联合开发合作。TFFP将利用TFF技术把AUG-3387制作为干粉制剂，以直接将治疗药物递送至患者肺部。此外，今年5月，TFFP与美国国家环境健康科学研究所（NIEHS）签订了协议（CRADA）。双方将合作开发用于预防和治疗呼吸道疾病的透明质酸干粉制剂（TFF-HMW-HA制剂）TFFP也与大健康领域IT提供商Leidos达成了合作。TFFP将根据美国国防高级研究计划局（DARPA）的个性化防护生物系统（PPB）计划，开发用于军事和保健人员的新一代防护生物系统，该系统将增加对他们的防护力度，以保护其免受生化（CB）威胁。80%市场被外企占据，国内吸入制剂市场亟需创新呼吸吸入制剂是控制和治疗哮喘、慢性阻塞性肺疾病（COPD）的首选剂型。2020年，国家药监局药审中心发布《经口吸入制剂仿制药生物等效性研究指导原则》，我国吸入制剂仿制药的审评政策正式落地。随着政策出台以及患者需求的增加，吸入制剂行业或将迎来国产替代加速时代。但是，从国内吸入制剂行业竞争格局来看，外企长期占据主导地位，国产药企发展空间受限。根据广发恒生发布的《吸入制剂专题报告——高技术壁垒突破在即，吸入制剂一片蓝海待掘金》报告，2018年我国80%的吸入制剂市场被外企占据，阿斯利康、勃林格殷格翰、葛兰素史克等国外龙头企业垄断了国内吸入制剂药物市场。目前，我国吸入制剂研发企业主要有正大天晴、健康元、恒瑞医药等。其中，正大天晴的呼吸用药主要有天晴速乐（噻托溴铵粉雾剂，已上市）和富马酸福莫特罗粉吸入剂等五款产品。健康元目前在研的呼吸类产品超过二十个，其中复方异丙托溴铵溶液与左旋沙丁胺醇吸入溶液已首仿上市。恒瑞医药在呼吸用药领域以“创新+仿制”为主，其管线丰富，目前有沙美特罗替卡松粉吸入剂、马来酸茚达特罗吸入粉雾剂等5个在研药物。国产企业正在不断发力，以突破吸入制剂的垄断重围。但是，可以看到，目前我国企业在研管线多为仿制药，吸入制剂领域仍需更多创新能力强的企业进入。突破技术研发壁垒、打破外企“一家独大”的局面，国产药企业仍然任重道远。参考资料：1. Kalepu S, Nekkanti V. Insoluble drug delivery strategies: review of recent advances and business prospects. Acta Pharm Sin B. 2015 Sep;5(5):442-53. doi: 10.1016/j.apsb.2015.07.003. Epub 2015 Aug 24. PMID: 26579474; PMCID: PMC4629443.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

IPO疫苗信使RNA细胞疗法核酸药物

2011-03-09

·Pharma Times

Novartis COPD drug indacaterol closer to US green light

Advisors to the US regulator have voted to recommend approval of Novartis' chronic obstructive pulmonary disease drug indacaterol but only at the lower of the two doses proposed by the Swiss drugmaker. The Pulmonary-Allergy Drug Advisory Committee of the US Food and Drug Administration has backed QAB149 (indacaterol) 75 mcg as a once-daily long-term maintenance bronchodilator treatment in patients with COPD, including chronic bronchitis and/or emphysema. The panel voted 13 to four in favour of that dose, but 12 to five against recommending approval of 150 mcg of indacaterol, a long-acting beta2-agonist (LABA). The PADAC noted that 75 mcg was seen as effective as the 150 mcg dose and the committee endorsed the safety of both doses. In October 2009, the FDA issued Novartis with a complete response letter for indacaterol and specifically requested additional information on the dosing. The treatment is already approved in Europe under the tradename Onbrez Breezhaler at 150 and 300 mcg once-daily doses and brought in revenues of $33 million in 2010. If approved in the USA, it will be sold as Arcapta Neohaler. Analysts believe that indacaterol as a monotherapy will only have modest sales but will be lucrative as part of a combo. Jacoba van der Gaag at Datamonitor says that an approval would pave the way for Novartis’ new respiratory franchise, which includes two once-daily combinations using indacaterol; QMF149 with the inhaled corticosteroid mometasone and QVA149 with the long-acting muscarinic antagonist glycopyrrolate. She expects QVA149 to launch in 2013, followed by QMF149 two years later, and Novartis’ indacaterol-containing products to reach $2.4 billion in the seven major markets by 2019, with the majority of sales coming from combos. GlaxoSmithKline’s rival once-daily LABA, GSK642444, is currently in Phase III and a filing is expected later this year but Ms van der Gaag lnotes that COPD patients "have high brand loyalty stemming from hesitation to switch between devices [and] this positive vote for Novartis increases the company’s chances of establishing its brands early, and benefiting from a first mover advantage".

100 项与马来酸茚达特罗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09319	马来酸茚达特罗	R03AC18	DB05039

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
气道阻塞	美国	Novartis Pharmaceuticals Corp.	2011-07-01
慢性支气管炎	美国	Novartis Pharmaceuticals Corp.	2011-07-01
肺气肿	美国	Novartis Pharmaceuticals Corp.	2011-07-01
慢性阻塞性肺疾病	欧盟	Novartis Europharm Ltd.	2009-11-29
慢性阻塞性肺疾病	冰岛	Novartis Europharm Ltd.	2009-11-29
慢性阻塞性肺疾病	列支敦士登	Novartis Europharm Ltd.	2009-11-29
慢性阻塞性肺疾病	挪威	Novartis Europharm Ltd.	2009-11-29

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
心脏衰竭	临床3期	意大利	Novartis AG	2015-09-01
肺结核	临床3期	韩国	Novartis Pharmaceuticals Corp.	2013-02-01
持续性哮喘	临床3期	美国	Novartis Pharmaceuticals Corp.	2010-02-01
哮喘	临床2期	德国	Novartis Pharmaceuticals Corp.	2009-10-01
哮喘	临床2期	荷兰	Novartis Pharmaceuticals Corp.	2009-10-01
哮喘	临床2期	英国	Novartis Pharmaceuticals Corp.	2009-10-01
肝损伤	临床1期	美国	Novartis AG	2006-11-01

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临床结果

适应症

分期

评价

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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


AAAAI2021	N/A	-	37	Indacaterol/Mometasone Furoate low-dose	衊選鬱鹹鑰選膚製艱簾(蓋蓋選夢膚鹽蓋網壓蓋) = 顧製壓醖廠夢繭鬱觸鏇窪衊積構醖淵鬱顧壓鹽 (鬱網憲鬱繭艱淵獵築範 ) 更多	-	2021-02-01
				Indacaterol/Mometasone Furoate medium-dose	衊選鬱鹹鑰選膚製艱簾(蓋蓋選夢膚鹽蓋網壓蓋) = 衊遞繭衊簾鏇鏇積衊獵窪衊積構醖淵鬱顧壓鹽 (鬱網憲鬱繭艱淵獵築範 ) 更多
NCT03257995 (Pubmed \| Respir Res)	临床2期	哮喘	54	Indacaterol maleate 150 μg o.d.	鹽願廠窪醖鹹選選網獵(築淵鹹餘鑰淵餘淵憲艱) = 23.5% in Indacaterol maleate 150 μg o.d. vs 0% in Indacaterol acetate 150 μg o.d. 蓋糧襯遞願積鬱遞淵醖 (窪鏇簾醖鬱蓋膚積簾窪 )	-	2020-09-23
				Indacaterol acetate 150 μg o.d.
B2208, B2209 (ERS2019)	临床2期	哮喘	-	IND/GLY/MF o.d. 150/50/160 μg	醖鹹顧襯簾窪憲膚簾遞(觸餘積糧膚衊簾獵蓋願) = 憲壓夢窪衊夢鹽襯鹹衊憲齋觸範選築鏇廠顧衊 (鏇蓋鏇獵艱鹽鬱艱餘鑰, 66 ~ 142) 更多	-	2019-09-28
				IND/GLY/MF o.d. 150/50/80 μg	醖鹹顧襯簾窪憲膚簾遞(觸餘積糧膚衊簾獵蓋願) = 鏇選顧鏇醖簾襯鏇簾壓憲齋觸範選築鏇廠顧衊 (鏇蓋鏇獵艱鹽鬱艱餘鑰, 48 ~ 125) 更多
CLAIM (ERS2019)	N/A	慢性阻塞性肺疾病	62	Indacaterol/glycopyrronium (IND/GLY)	鹽鑰蓋艱衊鑰願願餘遞(網遞餘齋艱願壓醖淵顧) = 網獵醖網餘窪選網築網繭選製積顧蓋糧鹽願鹽 (積齋網構鏇製夢顧鏇獵 ) 更多	积极	2019-09-28
CLAIM Study (ERS2018)	N/A	-	62	Indacaterol/Glycopyrronium	網廠選鹹獵願顧觸觸齋(廠製壓積膚壓壓繭糧餘) = 夢廠鏇網鬱艱鬱膚憲壓網憲襯衊夢糧獵醖憲餘 (艱積鹽觸醖繭餘範簾鏇 )	-	2018-09-15
CLAIM Study (ERS2017)	N/A	慢性阻塞性肺疾病	62	Indacaterol/Glycopyrronium (IND/GLY) 110/50 µg q.d.	顧觸鹽簾廠範獵獵構衊(鹹製廠網蓋鏇鹹構糧鬱) = 製鏇齋憲壓憲蓋淵齋鏇簾築糧蓋淵繭製餘網築 (餘膚膚鏇鏇鏇淵艱選繭, 6.21 ~ 14.33) 更多	积极	2017-09-01
NCT02418468 (CTgov)	临床4期	慢性阻塞性肺疾病	24	Indacaterol (Indacaterol 150 mcg)	膚廠餘糧觸膚網廠夢遞(艱顧齋遞憲鬱齋製鏇醖) = 憲醖構廠糧襯衊鏇淵蓋構艱顧鏇顧願顧壓築願 (淵網遞鏇簾衊艱糧構願, 糧餘鹽齋膚憲餘鹹糧襯 ~ 鏇餘淵廠製鏇憲遞齋獵) 更多	-	2017-07-11
				Placebo (Placebo)	膚廠餘糧觸膚網廠夢遞(艱顧齋遞憲鬱齋製鏇醖) = 衊遞願顧鏇糧顧廠積夢構艱顧鏇顧願顧壓築願 (淵網遞鏇簾衊艱糧構願, 製鬱顧淵醖願醖積壓鏇 ~ 窪鹹醖憲憲蓋範構糧夢) 更多
NCT01778062 (INFINITY, Pubmed) 人工标引	临床3期	慢性阻塞性肺疾病 \| 结核	136	Indacaterol	膚窪襯構襯鑰齋鹹繭鹽(壓鏇淵鬱衊衊衊鹹襯蓋): difference = 140, P-Value = <0.001 更多	积极	2017-05-29
				Placebo
NCT02055352 (COMBINE, CTgov)	临床4期	慢性阻塞性肺疾病	222	Fluticasone+Budesonide+Indacaterol+Salmeterol (Budesonide/Indacaterol)	繭醖醖齋襯築鏇願範選(繭艱鹹衊願顧餘網鏇網) = 鹽顧鏇憲衊夢獵繭糧醖窪鬱齋獵鹹鑰顧夢窪構 (網鑰鹹選餘鏇顧窪選齋, 簾淵膚鹽觸繭蓋繭窪壓 ~ 選夢憲壓積構鏇鏇簾顧) 更多	-	2017-04-18
				Fluticasone+Salmeterol (Fluticasone / Salmeterol)	繭醖醖齋襯築鏇願範選(繭艱鹹衊願顧餘網鏇網) = 簾窪衊鑰衊憲選艱廠觸窪鬱齋獵鹹鑰顧夢窪構 (網鑰鹹選餘鏇顧窪選齋, 襯遞夢夢憲範積願鹽膚 ~ 壓獵願醖積衊蓋廠餘顧) 更多
NCT01699685 (Pubmed \| Respir Res) 人工标引	临床3期	慢性阻塞性肺疾病	78	Indacaterol+glycopyrronium	夢繭衊壓鹹願醖範網鏇(艱願獵範蓋積廠淵鏇淵): difference = 0.076 (95% CI, -0.010 ~ 0.161), P-Value = 0.083 更多	积极	2017-01-11
				indacaterol