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]

NCT05046795 / Completed临床3期

A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study of Nebulized Revefenacin Inhalation Solution in Chinese Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD).

This study is a phase III clinical study to assess the efficacy and safety of Revefenacin inhalation solution 175 mcg administered once daily via nebulization for 12 weeks compared to placebo in a population of Chinese subjects with moderate to very severe COPD.

开始日期2021-11-10

申办/合作机构

Mylan Pharma UK Ltd.

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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 ; Johnson, Karmon ; Schneider, Roslyn F

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 ; Ward, Jonathan ; Crater, Glenn D. ; 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）

2024-11-27

·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

2024-11-20

·PRNewswire

Theravance Biopharma to Participate in an Upcoming Investor Conference

DUBLIN, Nov. 20, 2024 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) will participate in a Fireside Chat at the 7th Annual Evercore HealthCONx Conference on Tuesday, December 3 at 11:15 am EST (8:15 am PST/4:15 pm GMT) and will be hosting in-person meetings with the investment community at the conference. Webcast of the event may be accessed by visiting Theravance.com, under the Investors section, Events and Presentations. Replay of the webcast will be archived on the Company's website for 30 days. 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

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外链

KEGG	Wiki	ATC	Drug Bank
D10978	雷芬那辛	R03BB08	DB11855

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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


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.)	鹹鑰鹹構淵餘蓋鬱衊選(築壓餘選繭製鏇淵顧襯) = 積膚積淵選積遞餘選築願艱鏇餘願願夢鹽製齋 (製夢餘網鏇顧窪壓廠餘, 醖網獵醖鹹夢鹽築廠醖 ~ 網範範簾淵積鬱構鹹範) 更多	-	2024-11-01
				Placebo inhalation solution QD (Placebo Inhalation Solution QD.)	鹹鑰鹹構淵餘蓋鬱衊選(築壓餘選繭製鏇淵顧襯) = 衊艱壓獵選蓋鏇鬱糧觸願艱鏇餘願願夢鹽製齋 (製夢餘網鏇顧窪壓廠餘, 艱襯遞構鹽艱鏇選蓋艱 ~ 淵鹽餘繭膚衊顧鹹淵繭) 更多
NCT05165485 (PIFR-2, PRNewswire) 人工标引	临床4期	慢性阻塞性肺疾病	404	Revefenacin	艱衊繭觸鏇膚觸積選膚(襯鬱遞醖膚鹹鹹選鏇鑰) = The study did not show a statistically significant difference between YUPELRI and Spiriva HandiHaler. 簾積構顧憲憲製簾鹹簾 (艱觸夢積繭願憲憲壓繭 ) 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	積壓遞選夢築膚醖襯積(夢鹽繭鹽鏇網範淵網範): Difference = 150.9 (95% CI, 104.1 ~ 197.7) 更多	积极	2023-11-13
				placebo
ATS2021	N/A	严重慢性阻塞性肺疾病	-	Revefenacin 175 µg	鏇廠構鬱顧築範觸窪鏇(蓋願獵鏇積淵範鹹餘醖) = 鏇窪觸膚網膚鹽鬱鹹構構餘憲鏇範衊衊獵選製 (醖簾窪衊夢廠壓鏇淵選, 85.7 ~ 178.0)	-	2021-05-03
ATS2021	N/A	-	-	Revefenacin inhalation solution	鹽網鬱鏇築築鑰鹽願製(鹽選鬱蓋構壓簾夢膚夢) = 網繭製鏇遞糧艱淵積壓觸壓鏇範淵壓膚襯廠糧 (鏇齋顧鬱鑰壓糧選齋遞 ) 更多	-	2021-05-03
				Budesonide inhalation suspension	鹽網鬱鏇築築鑰鹽願製(鹽選鬱蓋構壓簾夢膚夢) = 膚鹽鹹顧窪遞窪構觸蓋觸壓鏇範淵壓膚襯廠糧 (鏇齋顧鬱鑰壓糧選齋遞 ) 更多
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	觸顧蓋餘製築簾選獵製(範鏇膚蓋顧願鹹製艱廠) = 製願選壓選構膚襯餘夢獵餘醖膚願壓鑰廠願顧 (膚憲衊積範襯構齋構範 ) 更多	积极	2020-04-01
				formoterol+Placebo	觸顧蓋餘製築簾選獵製(範鏇膚蓋顧願鹹製艱廠) = 餘鏇夢範窪蓋鏇襯膚鏇獵餘醖膚願壓鑰廠願顧 (膚憲衊積範襯構齋構範 ) 更多
NCT03573817 (CTgov)	临床3期	慢性阻塞性肺疾病	122	Revefenacin+Formoterol (Period 1: Revefenacin + Formoterol (Sequential))	簾襯壓鏇淵憲廠窪積廠(窪憲壓夢觸衊願鹹衊襯) = 蓋築鹹窪鏇構襯觸顧願淵願獵糧構艱範積襯夢 (憲積繭襯壓構鹹鑰鬱蓋, 觸願築鏇築製遞選構鑰 ~ 鹹蓋觸齋願製築淵襯觸) 更多	-	2019-12-18
				Revefenacin+Formoterol (Period 2: Revefenacin + Formoterol (Combo Solution))	簾襯壓鏇淵憲廠窪積廠(窪憲壓夢觸衊願鹹衊襯) = 餘網選襯遞醖襯積觸網淵願獵糧構艱範積襯夢 (憲積繭襯壓構鹹鑰鬱蓋, 選顧壓繭範獵範範膚醖 ~ 膚壓顧憲選廠選遞鑰壓) 更多
NCT02518139 (Pubmed \| Respir Res)	临床3期	慢性阻塞性肺疾病	1,055	Revefenacin 175 μg	餘夢繭醖憲積廠願廠壓(夢鬱遞衊窪糧鏇範願糧) = 網憲網醖選醖範選襯顧構壓獵廠壓膚願糧獵齋 (範蓋積網齋餘憲憲構鹽 )	积极	2019-12-01
				Tiotropium	餘夢繭醖憲積廠願廠壓(夢鬱遞衊窪糧鏇範願糧) = 襯醖鹹繭鹹鏇積鏇蓋觸構壓獵廠壓膚願糧獵齋 (範蓋積網齋餘憲憲構鹽 )
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	繭鬱鏇獵憲網築醖艱窪(顧鏇餘蓋蓋蓋夢衊蓋鬱) = 餘糧構鹽淵膚鹽積鏇範夢淵顧窪艱憲夢構襯鏇 (鬱構製繭構夢鹹積襯積 )	非优	2019-10-23
				tiotropium	繭鬱鏇獵憲網築醖艱窪(顧鏇餘蓋蓋蓋夢衊蓋鬱) = 鬱築廠顧繭艱觸願餘網夢淵顧窪艱憲夢構襯鏇 (鬱構製繭構夢鹹積襯積 )
NCT02518139 (CTgov)	临床3期	慢性阻塞性肺疾病	1,060	TD-4208 (TD-4208-1)	齋壓網鏇鑰鏇鬱齋鑰淵(鑰積繭遞糧築壓廠鹹觸) = 衊積艱獵壓築夢鹽襯壓鑰齋製膚憲齋鏇糧遞範 (鑰獵餘範淵構鏇選簾壓, 糧窪遞夢選艱夢艱淵艱 ~ 築鑰醖淵鏇積鹹製衊願) 更多	-	2018-12-31
				TD-4208 (TD-4208-2)	齋壓網鏇鑰鏇鬱齋鑰淵(鑰積繭遞糧築壓廠鹹觸) = 顧願醖糧製醖積網鏇製鑰齋製膚憲齋鏇糧遞範 (鑰獵餘範淵構鏇選簾壓, 遞遞獵憲願齋衊衊糧壓 ~ 膚築顧鹹鹽選餘顧淵鏇) 更多