A Double-Blind, placebo-controlled study of nebulized revefenacin inhalation solution in Indian Subjects with moderate to very severe chronic obstructive pulmonary disease (COPD).

开始日期2022-09-13

申办/合作机构

Mylan Pharmaceuticals Pvt Ltd.

NCT05165485

/ Completed临床4期

A Phase 4, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Study Comparing Improvements in Lung Function in Adults With Severe to Very Severe Chronic Obstructive Pulmonary Disease and Suboptimal Inspiratory Flow Rate Following Once-Daily Treatment Over 12 Weeks With Either Revefenacin Inhalation Solution Delivered Via Standard Jet Nebulizer or Tiotropium Delivered Via a Dry Powder Inhaler (Spiriva® HandiHaler®)

Study is a randomized, double-blind, double-dummy, parallel-group study evaluating efficacy and safety of revefenacin vs. tiotropium in adults with severe to very severe COPD and suboptimal PIFR.

开始日期2022-01-07

申办/合作机构

Theravance Biopharma, Inc.

[+1]

CTR20212308

/ Completed临床3期

一项中度至极重度慢性阻塞性肺疾病（COPD）中国受试者接受 Revefenacin 雾化吸入用溶液治疗的随机、双盲、安慰剂对照、平行研究

在中国中度至极重度 COPD 受试者人群中，证实与安慰剂相比，revefenacin 吸入用溶液 175 mcg 每日一次雾化治疗 12 周的有效性

开始日期2021-11-10

申办/合作机构

The Ritedose Corp.

[+2]

100 项与雷芬那辛相关的临床结果

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100 项与雷芬那辛相关的转化医学

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100 项与雷芬那辛相关的专利（医药）

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项与雷芬那辛相关的文献（医药）

2023-03-01·Respiratory medicine

Improvements in health status with revefenacin, a once-daily, nebulized, long-acting muscarinic antagonist for chronic obstructive pulmonary disease

Article

作者: Ferguson, Gary T ; Ohar, Jill A ; Donohue, James F ; Lombardi, David A ; Schneider, Roslyn F ; Johnson, Karmon

BACKGROUND:

Replicate, 12-week, phase 3 trials (0126 and 0127) of once-daily nebulized revefenacin 175 μg vs placebo demonstrated significant bronchodilation and improvements in health status in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). This post hoc analysis evaluated improvement in patient-reported outcomes (PROs), including the St. George's Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT), and Clinical COPD Questionnaire (CCQ) in both women and men.

METHODS:

Participants were pooled from the two 12-week studies (411 [51%] women and 401 [49%] men). Changes in PROs were assessed overall and separately in men and women.

RESULTS:

Revefenacin improved SGRQ and CAT total scores from baseline in both studies; improvement in CCQ total score reached significance only in 0126. In pooled data, a greater proportion of patients achieved clinically meaningful response in SGRQ score (≥4-unit decrease from baseline) with revefenacin vs placebo (odds ratio, 1.5; 95% confidence interval, 1.1-2.1; P = 0.012). Clinically meaningful responses were also seen in CAT (≥2-unit decrease from baseline) and CCQ (≥0.4-unit decrease from baseline) scores with revefenacin vs placebo. When stratified by sex, improvements from baseline in SGRQ, CAT, and CCQ scores following revefenacin vs placebo reached statistical significance only in women.

CONCLUSIONS:

Maintenance treatment with revefenacin improved health status in patients with moderate to very severe COPD; however, the effect was more pronounced for women than men.

CLINICALTRIALS:

GOV: NCT02459080; NCT02512510.

2022-03-01·Heart & lung : the journal of critical care4区 · 医学

Safety evaluation of revefenacin at the approved dose in patients with chronic obstructive pulmonary disease: A meta-analysis

4区 · 医学

Article

作者: Zan, Shuangjiang ; Liu, Baofeng ; Luo, Weishun

BACKGROUND:

Revefenacin is the first once-daily long-acting muscarinic antagonist (LAMA) for nebulization use in maintenance therapy for patients with chronic obstructive pulmonary disease (COPD).

OBJECTIVE:

To investigate the safety and tolerability profile of revefenacin at the approved dose (175 μg), compared with placebo and a lower dose (88 μg), for the treatment of COPD.

METHODS:

Available randomized controlled trials (RCTs), both published and unpublished, were identified via databases. Risk differences (RDs) and risk ratios (RRs), with their corresponding 95% confidence intervals (CIs) were calculated as effect sizes.

RESULTS:

One unpublished RCT and four articles containing 5 RCTs were included. Combined results showed that there were no significant differences between COPD patients receiving 175 μg revefenacin and those receiving a placebo, concerning the risk of discontinuation due to adverse events (AEs), any all-grade AE, or any serious AE. 175 μg revefenacin also did not significantly increase the risk of antimuscarinic-related AEs, cardiovascular AEs, or 12 commonly reported AEs. Plus, a lower dose of 88 μg was shown to share a comparable safety profile with the 175 μg revefenacin. A non-significant trend towards a decrease in risks of AEs for 175 μg revefenacin was observed. The most frequently reported AE for each group was COPD worsening/exacerbation.

CONCLUSION:

Revefenacin at the approved dose is generally well-tolerated and safe with minimal AEs, which supports its use as a once-daily nebulized LAMA for the treatment of moderate to severe stable COPD. Additional studies are needed to complete the safety and tolerability profile.

2022-01-01·Therapeutic Advances in Respiratory Disease3区 · 医学

Lung deposition of inhaled once-daily long-acting muscarinic antagonists via standard jet nebulizer or dry powder inhaler, measured using functional respiratory imaging, in patients with chronic obstructive pulmonary disease

3区 · 医学

ArticleOA

作者: Johnson, Karmon ; Crater, Glenn D. ; Ward, Jonathan ; Backer, Jan De

Background::

Data for bronchodilator deposition via nebulizers and dry powder inhalers (DPIs) in the respiratory tract of patients with chronic obstructive pulmonary disease (COPD) are limited. We used functional respiratory imaging (FRI) to determine deposition patterns for revefenacin solution via a PARI LC® Sprint® nebulizer and tiotropium powder via HandiHaler® DPI.

Methods::

Ten patients with COPD, of whom 9 had severe airflow obstruction, were selected from FLUIDDA’s database. The study did not enroll patients. Drug deposition in the extrathoracic and intrathoracic regions, including the central and peripheral airways was simulated by FRI. The percentage of delivered dose and central-to-peripheral (C/P) deposition ratio for nebulizer and DPI were evaluated.

Results::

Mean ± standard deviation (SD) age was 64.7 ± 7.1 years, height was 168.8 ± 8.5 cm, and percent predicted forced expiratory volume in 1 s was 40.8 ± 12.3%; 50% of patients were men. At optimal inhalation flow, intrathoracic and peripheral deposition was three-fold higher for revefenacin via nebulizer than tiotropium via HandiHaler (mean ± SD 34.6 ± 8.53% versus 10.9 ± 5.67% and 18.2 ± 4.30% versus 5.8 ± 2.73% of delivered dose, respectively). Similar results were observed for suboptimal flow (mean ± SD percentage of revefenacin versus tiotropium: intrathoracic, 32.1 ± 8.3% versus 15.1 ± 5.9%; peripheral; 16.6 ± 4.1% versus 8.4 ± 2.9%). The C/P deposition ratio for nebulizer was similar to DPI (mean ± SD 0.915 ± 0.241 versus 0.812 ± 0.249 at optimal; 0.947 ± 0.253 versus 0.784 ± 0.219 at suboptimal flow), even though the mass median aerodynamic diameter of revefenacin was higher than tiotropium. C/P deposition ratio for revefenacin decreased after bronchodilation (0.915 ± 0.241 pre-bronchodilation versus 0.799 ± 0.192 post-bronchodilation), suggesting progressively better deposition in the peripheral region, assuming bronchodilation occurred during the nebulization process.

Conclusions::

These results demonstrate more efficient intrathoracic and peripheral deposition for revefenacin via standard jet nebulizer than tiotropium via HandiHaler, with similar C/P deposition ratio in patients with COPD. Nebulizers are an efficient alternative to DPIs for bronchodilator administration in patients with COPD.

项与雷芬那辛相关的新闻（医药）

2024-12-17

·PRNewswire

Theravance Biopharma to Conduct Investor Meetings During the J.P. Morgan 43rd Annual Healthcare Conference

DUBLIN, Dec. 17, 2024 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) today announced that members of its management team will hold investor meetings during the 43rd Annual J.P. Morgan Healthcare Conference, January 13-16, 2025, in San Francisco, CA. To request a one-on-one meeting with the Theravance Biopharma management team, please contact us at [email protected]. About Theravance Biopharma Theravance Biopharma, Inc.'s focus is to deliver Medicines that Make a Difference® in people's lives. In pursuit of its purpose, Theravance Biopharma leverages decades of expertise, which has led to the development of FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Ampreloxetine, its late-stage investigational once-daily norepinephrine reuptake inhibitor in development for symptomatic neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA), has the potential to be a first in class therapy effective in treating a constellation of cardinal symptoms in MSA patients. The Company is committed to creating/driving shareholder value. For more information, please visit . THERAVANCE BIOPHARMA®, THERAVANCE® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries). YUPELRI® is a registered trademark of Mylan Specialty L.P., a Viatris company. Trademarks, trade names or service marks of other companies appearing in this press release are the property of their respective owners. Contact: [email protected] 650-808-4045 SOURCE Theravance Biopharma, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准

2024-11-27

·同写意

长风药业慢性阻塞性肺病（COPD）领域新产品雷芬那辛吸入溶液获批临床 | 会员动态

诊断试剂

2024-11-22

·长风药业

重磅丨长风药业慢性阻塞性肺病(COPD)领域新产品雷芬那辛吸入溶液获批临床

近日，长风药业股份有限公司自主研制的新产品吸入用雷芬那辛溶液获得国家药品监督管理局(NMPA)的临床默示许可。雷芬那辛(Revefenacin)作为一种长效毒蕈碱拮抗药(LAMA)，每天仅需吸入一次，为患者提供治疗的同时，极大的提高患者的便利性。慢阻肺防治，从了解开始 2024年11月20日，我们迎来了全球第23个“世界慢性阻塞性肺疾病日”(COPD日)。慢性阻塞性肺疾病(COPD)是一种由多重因素引发的慢性呼吸系统疾病，其主要症状包括持续的气促、咳嗽以及咳痰，这些均源于气道的持续性和进展性阻塞。患者常常会受到咳嗽、痰液过多、胸部紧迫感以及呼吸急促的困扰，而在病情严重时，甚至可能并发气胸、肺心病以及肺性脑病等严重问题。治疗COPD的核心目标在于改善患者的呼吸功能，从而减轻由慢性缺氧所引起的各种症状。为此，患者可能需要长期坚持药物治疗。其中，吸入药物作为COPD治疗的关键手段，因其能够直接作用于肺部并显著降低全身不良反应，而在缓解症状、预防病情恶化等方面发挥着至关重要的作用。然而，传统的吸入药物往往需要患者频繁使用，这不仅对患者的日常生活质量造成了影响，还增加了用药过程中的复杂性和出错风险。对于众多老年患者，特别是那些记忆力减退或行动不便的患者来说，多次用药无疑成为了一项沉重的负担。数据显示，我国老年人COPD的患病率随年龄增长而显著上升，60~69岁人群的患病率为21.2%，而70岁及以上老年人的患病率更是高达35.5%。但令人担忧的是，老年人群中对COPD的知晓率仅为8.1%，在已确诊的患者中，仅有2.6%真正意识到自己的疾病状况，仅有12.0%的患者报告曾接受过肺功能检查[1]。这些数据表明，提升患者用药的便利性对于提高COPD的诊断率和治疗率至关重要。此外，COPD患者在外出或特殊时期（如节假日）还可能面临停药的风险。由于吸入药物需要持续使用才能维持其治疗效果，因此一旦停药，很可能导致气道炎症的反复发作，进而增加病情急性加重的风险。因此，我们必须重视并努力解决这些问题，以确保COPD患者能够得到更加便捷、有效的治疗。呼吸之间，生命质量——共筑慢阻肺防线雷芬那辛吸入溶液作为美国FDA批准的首款每日仅需使用一次的长效雾化支气管扩张剂，显著简化了COPD患者的用药步骤，极大地提升了用药的便捷度与患者的依从性。对于需长期接受治疗的COPD患者而言，减少用药频次不仅减轻了他们的记忆负担，还降低了因操作频繁而可能导致的失误，从而有助于更稳定地控制病情。此次吸入用雷芬那辛溶液成功获得临床默示许可，长风药业在COPD治疗领域的产品线再次迎来了重要补充。我们满怀期待，希望这款药物能够给COPD患者带来更多的治疗选择，使他们摆脱繁琐的用药流程，进而提升整体生活质量。参考文献 [1] 中国老年医学学会呼吸病学分会慢性阻塞性肺疾病学组，中国老年慢性阻塞性肺疾病临床诊治实践指南，中华结核和呼吸杂志. 2020,43(02):100-119.DOI:10.3760/cma.j.issn.10010939.2020.02.007 长风药业 —BREATHE EASIER, LIVE BETTER— 长风药业以提高人类的生命质量和健康水平为己任，以开发高质量的呼吸系统用药为目标，致力于研发、生产和销售具有安全、有效、惠及大众的各类吸入制剂药物。公司建立了覆盖吸入气雾剂、吸入粉雾剂、吸入液体制剂、吸入喷雾剂、鼻喷雾剂、脂质体在内的多剂型研发管线。希望成为集呼吸系统药物研发、产业化和商业化为一体的行业知名药企。推荐阅读 ● 重磅｜长风药业慢性阻塞性肺病（COPD）领域新产品噻托溴铵吸入粉雾剂获得临床默示许可 ● FDA获批！长风药业慢性阻塞性肺疾病（COPD）治疗领域新产品吸入用阿福特罗雾化溶液获批上市 ● 长风速递 | 长风药业蝉联2024未来医疗100强 ● 长风速递 | 深耕细作！长风药业获得高新技术企业认定

100 项与雷芬那辛相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10978	雷芬那辛	R03BB08	DB11855

研发状态

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适应症	国家/地区	公司	日期
慢性阻塞性肺疾病	美国	Mylan Ireland Ltd.	2018-11-09

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适应症	最高研发状态	国家/地区	公司	日期
呼吸衰竭	临床2期	美国	Theravance Biopharma, Inc.	2020-11-01
呼吸衰竭	临床2期	美国	Mylan Pharmaceuticals, Inc.	2020-11-01
呼吸功能不全	临床2期	美国	Theravance Biopharma, Inc.	2020-11-01
呼吸功能不全	临床2期	美国	Mylan Pharmaceuticals, Inc.	2020-11-01
肾功能不全	临床1期	美国	Theravance Biopharma, Inc.	2015-12-01
肾功能不全	临床1期	美国	Mylan, Inc.	2015-12-01
肝病	临床1期	美国	Mylan, Inc.	2015-11-01
肝病	临床1期	美国	Theravance Biopharma, Inc.	2015-11-01

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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


NCT05165485 (PIFR-2, CTgov)	临床4期	慢性阻塞性肺疾病	404	Revefenacin Placebo+Tiotropium (Tiotropium)	壓選鬱網觸憲憲遞願艱(廠網製壓廠鹽膚夢餘淵) = 選鏇選蓋餘艱淵蓋願顧範齋繭鬱觸艱獵鬱遞簾 (糧憲窪鹽繭獵鹹夢衊廠, 積醖艱鹽顧窪願鹹遞構 ~ 遞遞襯鹹築遞製廠範構) 更多	-	2024-12-20
				Tiotropium Placebo+Revefenacin (Revefenacin)	壓選鬱網觸憲憲遞願艱(廠網製壓廠鹽膚夢餘淵) = 顧襯蓋餘網蓋鏇廠廠網範齋繭鬱觸艱獵鬱遞簾 (糧憲窪鹽繭獵鹹夢衊廠, 網顧構願遞構遞願窪願 ~ 夢衊製艱觸遞窪壓獵齋) 更多
NCT05046795 (CTgov)	临床3期	慢性阻塞性肺疾病	258	Revefenacin 175 mcg in 3 ML Inhalation Solution (Revefenacin Inhalation Solution 175 mcg QD.)	構鏇餘積餘繭鬱糧構壓(窪願糧網憲繭顧鑰餘夢) = 範選餘窪艱夢襯襯構艱餘淵鹹獵鹹簾遞鏇遞醖 (範築膚夢獵網構鬱鹹齋, 餘膚遞憲糧蓋鬱積壓膚 ~ 製選壓憲醖鬱製夢觸衊) 更多	-	2024-11-01
				Placebo inhalation solution QD (Placebo Inhalation Solution QD.)	構鏇餘積餘繭鬱糧構壓(窪願糧網憲繭顧鑰餘夢) = 醖淵窪積醖餘廠齋窪鑰餘淵鹹獵鹹簾遞鏇遞醖 (範築膚夢獵網構鬱鹹齋, 壓鹽窪蓋膚憲鏇簾選鏇 ~ 廠鏇構鑰糧製繭簾鬱衊) 更多
NCT05165485 (PIFR-2, PRNewswire) 人工标引	临床4期	慢性阻塞性肺疾病	404	Revefenacin	憲夢範願夢製積鏇衊選(糧糧繭壓顧鏇糧鹽築願) = The study did not show a statistically significant difference between YUPELRI and Spiriva HandiHaler. 選艱顧艱範鹽餘廠遞壓 (蓋願膚憲鏇鏇醖獵鬱壓 ) 未达到	不佳	2024-01-05
				Tiotropium
NCT05046795 (PRNewswire) 人工标引	临床3期	慢性阻塞性肺疾病	257	YUPELRI	繭網衊鹽膚夢鹽築範遞(鹹衊蓋糧艱鏇齋顧艱鏇): Difference = 150.9 (95% CI, 104.1 ~ 197.7) 更多	积极	2023-11-13
				placebo
ATS2021	N/A	-	-	Revefenacin inhalation solution	壓獵壓壓窪鏇膚繭壓糧(蓋衊醖鑰餘餘廠糧網醖) = 夢願憲鹹遞遞艱鹹繭艱網淵餘糧蓋觸淵憲製繭 (鑰積鏇遞壓選觸醖糧積 ) 更多	-	2021-05-03
				Budesonide inhalation suspension	壓獵壓壓窪鏇膚繭壓糧(蓋衊醖鑰餘餘廠糧網醖) = 繭範鏇衊衊積鑰窪繭鏇網淵餘糧蓋觸淵憲製繭 (鑰積鏇遞壓選觸醖糧積 ) 更多
ATS2021	N/A	严重慢性阻塞性肺疾病	-	Revefenacin 175 µg	築糧鏇製鬱醖夢鬱範夢(襯獵糧夢餘窪觸獵襯鑰) = 蓋蓋鹹襯齋積鹽鬱鏇壓襯壓積襯醖襯膚網憲糧 (艱製淵鹹淵醖糧廠遞鬱, 85.7 ~ 178.0)	-	2021-05-03
NCT03573817 (Pubmed \| Chronic Obstr Pulm Dis) 人工标引	临床3期	慢性阻塞性肺疾病	122	formoterol+revenacin	築窪餘窪艱範網觸遞襯(餘夢蓋選衊憲構簾選艱) = 築蓋遞願襯積鏇艱淵築鑰範淵艱網觸顧襯顧鹽 (壓膚廠願顧願膚繭壓襯 ) 更多	积极	2020-04-01
				formoterol+Placebo	築窪餘窪艱範網觸遞襯(餘夢蓋選衊憲構簾選艱) = 觸襯憲夢製醖窪鏇鹽鬱鑰範淵艱網觸顧襯顧鹽 (壓膚廠願顧願膚繭壓襯 ) 更多
NCT03573817 (CTgov)	临床3期	慢性阻塞性肺疾病	122	Revefenacin+Formoterol (Period 1: Revefenacin + Formoterol (Sequential))	積鏇鹽積築遞遞壓顧鏇(願膚齋淵鬱範願壓衊糧) = 顧選窪顧顧蓋遞鏇膚衊淵艱積鬱糧繭願窪鏇襯 (鬱願醖鏇衊願衊鹽製憲, 齋願鏇鬱鏇膚夢簾築餘 ~ 願鬱獵積顧廠獵餘窪襯) 更多	-	2019-12-18
				Revefenacin+Formoterol (Period 2: Revefenacin + Formoterol (Combo Solution))	積鏇鹽積築遞遞壓顧鏇(願膚齋淵鬱範願壓衊糧) = 鹹襯遞鹽艱襯鏇網繭窪淵艱積鬱糧繭願窪鏇襯 (鬱願醖鏇衊願衊鹽製憲, 繭製遞製餘構顧鑰蓋獵 ~ 憲鹹簾顧窪製鬱網顧顧) 更多
NCT02518139 (Pubmed \| Respir Res)	临床3期	慢性阻塞性肺疾病	1,055	Revefenacin 175 μg	顧構壓簾鏇遞憲願艱築(醖範鏇鬱鏇繭糧鬱鬱蓋) = 鑰襯鏇網積鏇顧淵壓積鹹糧蓋膚壓鬱壓醖餘衊 (齋積製簾網鹹壓願鏇淵 )	积极	2019-12-01
				Tiotropium	顧構壓簾鏇遞憲願艱築(醖範鏇鬱鏇繭糧鬱鬱蓋) = 願範製壓製膚齋糧築憲鹹糧蓋膚壓鬱壓醖餘衊 (齋積製簾網鹹壓願鏇淵 )
NCT03095456 (0149, Pubmed \| Chronic Obstr Pulm Dis) 人工标引	临床3期	慢性阻塞性肺疾病	206	revefenacin	淵鑰蓋蓋醖淵壓鹹構築(鹹範獵範製繭夢憲網繭) = 鹹範鑰齋築衊淵鑰獵淵鹹選鬱願夢鹽鏇築鬱鏇 (餘艱網淵願選網鬱製糧 )	非优	2019-10-23
				tiotropium	淵鑰蓋蓋醖淵壓鹹構築(鹹範獵範製繭夢憲網繭) = 積糧鹽鏇壓糧範獵窪襯鹹選鬱願夢鹽鏇築鬱鏇 (餘艱網淵願選網鬱製糧 )