A prospective, open label, single-arm, multicentre, phase IV clinical trial to assess efficacy and safety of Vilanterol,Glycopyrronium and Fluticasone furoate powder for Inhalation in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) - NIL

开始日期2025-12-20

申办/合作机构

Zydus Healthcare Ltd.

CTRI/2025/04/085135

/ Not yet recruiting临床4期

A prospective, open label, single-arm, multicentre, active post-marketing surveillance study to assess safety and effectiveness of Vilanterol 25 mcg and Fluticasone Furoate 200 mcg powder for inhalation in patients with asthma. - NIL

开始日期2025-05-01

申办/合作机构

Zydus Healthcare Ltd.

NCT07380178

/ CompletedN/A

The Effect of Apple Fruit Extract (Malus Sylvestris Mill) as an Antioxidant and Anti-Inflammatory on Allergic Rhinitis

This study was conducted to see before and after treatment whether it provided improvement in the patient's clinical symptoms.

开始日期2025-04-01

申办/合作机构

Universitas Sebelas Maret

100 项与糠酸氟替卡松相关的临床结果

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100 项与糠酸氟替卡松相关的转化医学

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100 项与糠酸氟替卡松相关的专利（医药）

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1,726

项与糠酸氟替卡松相关的文献（医药）

2026-04-01·INTERNATIONAL DENTAL JOURNAL

Exploration Novel Therapeutic Targets for Periodontitis via Stress Granules Biomarkers

Article

作者: Shi, Bowei ; Chen, Jialu ; Zhuang, Hai ; Yang, Xie ; Wang, Yu ; Zhu, Bowen

BACKGROUND:

Periodontitis (PD) is associated with stress granules (SGs), which are involved in cellular stress responses. Identifying biomarkers related to SGs in PD is key to grasping its pathogenesis and devising novel therapeutic approaches.

METHODS:

Microarray datasets GSE10334 and GSE106090 were downloaded from public databases, and experimental verification was conducted. Differentially expressed genes (DEGs) were determined via differential expression analysis and intersected with SGs-related genes (SGs-RGs). Machine learning methods and gene expression validation were used to further refine the biomarkers. Subsequently, a nomogram was constructed for disease prediction, and its accuracy was evaluated. Enrichment analysis was performed to investigate signalling pathways, and immune cell infiltration was analysed. Moreover, a transcription factor (TF) regulatory network and a disease-biomarker-drug interaction network were constructed.

RESULTS:

A total of 1618 DEGs, 95 candidate genes, and 4 biomarkers (PECAM1, IL18, EGFR, and CCL5) were identified. PECAM1 and CCL5 showed significant overexpression, while IL18 and EGFR showed significant underexpression in PD patients. The nomogram based on these biomarkers showed high predictive accuracy. Enrichment analysis revealed that the biomarkers were primarily accumulated within translation pathways, like ribosome and rRNA processing. Besides, 14 differentially infiltrated immune cell types were identified, with significant positive correlations between IL18/EGFR and memory B cells, PECAM1/CCL5 and plasma cells. Notably, TFs such as CEBPB, ELF1, and STAT3 were identified as important regulatory factors for the biomarkers. Potential drugs for the biomarkers included mycophenolate, afatinib, and fluticasone, and the biomarkers were associated with diseases such as gingivitis, diabetes, and cardiovascular diseases.

CONCLUSIONS:

This study identified four SGs-related biomarkers in PD and proposed potential therapeutic targets, providing preliminary insights into its pathogenesis that warrant further experimental validation at the protein and functional levels.

2026-02-01·BMJ Evidence-Based Medicine

Adverse events of inhaled corticosteroids in adult patients with asthma or chronic obstructive pulmonary disease: pairwise, network and dose–response meta-analyses

Review

作者: Wang, Guojun ; Peng, Li ; Jiang, Xinrui ; Pu, Xiaofeng ; Huang, Yunbei ; Zhang, Yinhui ; Zhang, Zhengji ; Wang, Maolin ; Xu, Mengyao

Objectives:

This study aimed to evaluate the associations between inhaled corticosteroids (ICSs) and adverse events (AEs) in adults with asthma or chronic obstructive pulmonary disease (COPD) and to explore variations by ICS type and dosage.

Design and setting:

Medline/PubMed, Embase, the Cochrane Central Register of Controlled Trials and ClinicalTrials.gov were searched from inception to 20 February 2025. Data extraction and synthesis were performed, estimating risk ratios (RRs) with 95% confidence intervals (CI) or credible intervals (CrI) through pairwise and network meta-analysis (NMA), and an NMA using the Emax model was employed to find the dose–response relationships of the AEs of each ICS. Risk of bias was evaluated across both pairwise and NMAs. The certainty of evidence, based on the GRADE approach, was assessed exclusively for the NMA estimates.

Participants:

Adults diagnosed with asthma or COPD treated with ICSs compared with non-ICS controls or those receiving different types or doses of ICSs.

Main outcome measures:

The primary outcomes were AEs, including pneumonia, oral candidiasis, upper respiratory tract infection (URTI), fracture, diabetes, cataract and plasma cortisol abnormalities. Secondary outcomes included efficacy-related endpoints: asthma exacerbations, COPD exacerbations and all-cause mortality.

Results:

129 trials (120 900 participants) were included. According to pairwise meta-analysis, ICSs were associated with a higher risk of pneumonia (RR 1.49, 95% CI 1.38 to 1.61) and oral candidiasis (RR 2.29, 95% CI 2.01 to 2.60) and with a slightly higher risk of URTI (RR 1.17, 95% CI 1.10 to 1.25), compared with control. Besides, ICSs were linked to a reduced risk of asthma exacerbations (RR 0.30, 95% CI 0.20 to 0.45) and COPD exacerbations (RR 0.90, 95% CI 0.86 to 0.94) vs control. The results of the NMA that explored differences by ICS type showed that beclomethasone and fluticasone increased pneumonia risk compared with control, with absolute risk increases of up to 2.3%. Fluticasone also showed a slightly higher pneumonia risk than budesonide. Besides, mometasone, beclomethasone, budesonide and fluticasone were associated with increased risk of oral candidiasis, with the highest increase observed for mometasone (4.3%). In contrast, ciclesonide consistently showed lower risk across comparisons, reducing oral candidiasis by up to 4.5% with other ICSs. Fluticasone modestly increased URTI, while ciclesonide reduced it. Budesonide and mometasone were also associated with a small increase in cataract risk. Most of the outcomes reported here were supported by moderate- to high-certainty evidence. Furthermore, the dose–response relationship estimated from the Emax model indicated significant associations between fluticasone dose and the risks of pneumonia and URTI, between multiple ICS doses and oral candidiasis and between budesonide dose and cataract.

Conclusions:

ICSs are correlated with the escalated risk of pneumonia, oral candidiasis and URTI in adult patients with asthma or COPD, but ICSs could reduce asthma exacerbations and COPD exacerbations. Fluticasone, beclomethasone, budesonide and mometasone are independently linked to certain AEs, and some Emax dose–response relationships are detected.Our findings may help guide individualised ICS use by informing benefit-risk considerations across various formulations and dosing regimens.

PROSPERO registration number:

CRD42024527797.

2026-02-01·BMJ Open Respiratory Research

Economic evaluation of single-inhaler triple therapy for chronic obstructive pulmonary disease in Thailand

Article

作者: Niyompattama, Anuchit ; Dilokthornsakul, Piyawat ; Chongmelaxme, Bunchai ; Dilokthornsakul, Piyameth

Introduction:

Single-inhaler triple therapy (SITT) is known to be a cost-effective intervention for chronic obstructive pulmonary disease (COPD)in Western countries, but there is no such evidence for resource-limited countries. This study aimed to evaluate the cost-utility of SITT compared with multiple inhaler triple therapy (MITT) for COPD in Thailand.

Methods:

A Markov model with a lifetime horizon from a societal perspective was conducted with seven health states, including moderate, severe and very severe, with and without acute exacerbation (AE) and death. Two SITTs, fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) and budesonide/glycopyrrolate/formoterol (BUD/GLY/FOR), were compared with MITT (salmeterol/fluticasone propionate with tiotropium (SAL/FP+TIO). A comprehensive literature review was performed to identify inputs. A quality-adjusted life year (QALY) and incremental cost-effectiveness ratio (ICER) were calculated. A series of sensitivity analyses was performed.

Results:

FF/UMEC/VI could improve QALY by 0.014 with an increased lifetime cost of 25 649 Thai baht (THB) ($727) compared with SAL/FP+TIO. In contrast, BUD/GLY/FOR had a lower QALY of −0.007 with an increased total lifetime cost of 34,151 THB ($968). The ICER for FF/UMEC/VI was 1,899,408 THB/QALY ($53,823), while BUD/GLY/FOR was dominated by SAL/FP+TIO. Probabilistic sensitivity analysis indicated that FF/UMEC/VI had a 1.1% chance of being cost-effective at the threshold of 160,000 THB ($4,533). We found that a 30% reduction in FF/UMEC/VI price could lead to a cost-effective option.

Conclusion:

Our study indicated that SITTs are not cost-effective at the current price compared with the current MITT for COPD treatment. However, FF/UMEC/VI could be a promising option, with an approximately 30% price reduction.

198

项与糠酸氟替卡松相关的新闻（医药）

2026-02-20

·Pharmaceutical Technology

Ex-Trump official-ran Altesa secures $75m in Series B funding round

Altesa will now progress its antiviral to a mid-stage trial. Credit: Kateryna Kon/ShutterStock.com Altesa BioSciences has closed an oversubscribed $75m Series B funding round to advance the clinical development of its antiviral, vapendavir. With funding from lead investor Forbion, as well as contributions from Sanofi and other venture capitalists, Altesa will progress vapendavir to Phase IIb trials in rhinovirus, a disease widely known as the common cold. Under the co-leadership of former US assistant health secretary, Brett Giroir and ex-GSK chief medical officer (CMO), Dr Katharine Knobil, the biotech will initiate the multinational CARDINAL study, which aims to enrol 900 patients with chronic obstructive pulmonary disease (COPD) to evaluate how treatment with vapendavir may impact the severity of rhinoviral-driven exacerbations within the disease. The trial is expected to begin in Q2 2026. According to Altesa, vapendavir could have the potential to prevent “up to 50% of COPD exacerbations” by stopping the common cold from infecting and reproducing within a host’s cells. The American Lung Association (ALA) currently cites respiratory diseases like cold and flu as the most common cause of exacerbations in COPD. Alongside its potential to reduce exacerbations, Knobil hopes that vapendavir can improve symptoms and maintain patient quality of life, while hastening the resolution of illness and potentially allowing patients to avoid advanced medical intervention. Vapedavir will head to Phase IIb with positive early-stage data under its belt, as the antiviral was found to diminish illness duration, inflammatory markers and both upper and lower airways symptoms in the Phase I Challenge study (NCT05962645). GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence COPD market takes a breath of fresh air Until recently, the COPD market was dominated by inhaled small molecule therapies, with combination options like GSK’s Telegy Ellipta (fluticasone furoate, umeclidinium bromide and vilanterol trifenatate) securing a strong share of the indication’s sales. However, the COPD approval of Sanofi and Regeneron’s biologic, Dupixent (dupilumab) as an add-on maintenance therapy marked the start of a biologics revolution – with GSK’s Nucala (mepolizumab) following in Dupixent’s footsteps in May 2025 and several candidates making their way through clinical trials. According to GlobalData’s Pharmaceutical Intelligence Center, there are currently 15 ongoing clinical trials evaluating eight biologics in COPD. GlobalData, the parent company of Pharmaceutical Technology , forecasts that the COPD market will be worth $30.2bn in 2033 .

临床2期上市批准临床1期

2026-02-06

·药研苑

葛兰素史克氟替美维吸入粉雾剂获批治疗哮喘

药品营销避坑”试读：药品导入期管理视频课（试听）药品生命周期管理（案例）药品立项需要注意什么（案例） 2026年1月23日，葛兰素史克宣布，中国国家药品监督管理局（NMPA）已批准全再乐®（氟替美维吸入粉雾剂）用于成人哮喘患者的维持治疗。此次获批主要基于CAPTAIN临床研究随机、双盲、阳性对照3a期临床试验的研究结果。CAPTAIN共纳入2436例吸入性糖皮质类固醇/长效β2受体激动剂（ICS/LABA）控制不佳的患者，这些患者尽管接受了ICS/LABA（>250mcg/天丙酸氟替卡松或等效剂量）维持治疗，但哮喘仍未得到充分控制。入组患者随机接受氟替美维（FF/UMEC/VI，糠酸氟替卡松（FF）+乌美溴铵（UMEC）+三苯乙酸维兰特罗（VI））100/62.5/25μg、200/62.5/25μg、100/31.25/25μg、200/31.25/25μg，或FF/VI 100/25μg、200/25μg，每日一次。至第24周，与FF/VI 100/25μg组相比，FF/UMEC/VI 100/62.5/25μg组FEV1较基线变化平均改善110ml（95% CI 66-153；p<0.0001）；与FF/VI 200/25μg组相比，FF/UMEC/VI 200/62.5/25μg组FEV1较基线变化平均改善92ml（95% CI 49-135；p<0.0001）。在安全性方面，不良事件发生率在各治疗组间相似，最常报告的不良事件为鼻咽炎、头痛和上呼吸道感染（Laurie A Lee., 2021）。氟替美维吸入粉雾剂（全再乐®）为吸入性糖皮质激素（ICS）糠酸氟替卡松（FF）、长效抗胆碱能药物（LAMA）乌美溴铵（UMEC）和长效β2受体激动剂（LABA）三苯乙酸维兰特罗（VI）组成的复方制剂，每日只需给药一次，已在国内获批治疗慢性阻塞性肺疾病（COPD）。推荐指数：★★★ 推荐原因：不仅拓展了氟替美维吸入粉雾剂的适应症，也为ICS/LABA控制不佳的哮喘患者提供了一个更加方面的治疗选择。相关阅读：辉瑞下一代GLP-1至28周减重达12.3%，且支持按月给药 40%，2期临床勃林格殷格翰Apecotrep降低FSGS蛋白尿诺华超30亿品种司库奇尤单抗再获新适应症（nr-axSpA） 2a期试验减重22.3%，Nimacimab抑制CB1增效司美格鲁肽老药新用，肌松药环苯扎林华丽变身治疗纤维肌痛综合征降糖减重双超司美格鲁肽，CagriSema REIMAGINE 2研究发布婴儿血管瘤再添新药，盐酸普萘洛尔滴剂获批先为达偏向型GLP-1药物埃诺格鲁肽国内获批治疗2型糖尿病 2025年1-3季度口崩片市场哪个强？ 2025年1-3季度口溶膜制剂哪家强？免疫检查点抑制剂，谁将成为下一个王者？质子泵相关抑酸类药物市场即将回暖改剂型，口服液体制剂“金矿”还是“陷阱” 中药1类新药距离封神还有多远药品导入期管理视频课相关内容只作为药物研发的参信息。不构成任何与用药咨询有关的建议。如需发稿，您可通过在药研苑公众号下以发送信息的方式将官网或官方公众号的稿件链接和标题发送给我们。我们将择优确定是否发布。

临床结果临床2期申请上市临床3期ASCO会议

2026-02-02

·医路漫漫学无止境

重度哮喘的诊治

重度哮喘：在过去的一年中，需要使用GINA指南建议的第4级或第5级治疗，才能够维持控制或即使在上述治疗下仍表现为“未控制”哮喘，分2种情况： 1、单纯重度哮喘：第4级治疗能够维持控制，但降级治疗会失去控制； 2、重度难治性哮喘：第4级治疗不能维持控制，需要采用第5级治疗。中国哮喘患病和发病危险因素的流行病学调查： 14岁以上哮喘患者发病率为1.24%，重症哮喘占7.1%，重度难治性哮喘占5.99%。重度哮喘的分型：重度哮喘是一组异质性极大的临床综合征，有多种亚型，其临床表现、生理指标和治疗反应个不相同，明确其表型和內型有助于预测患者的不同病程及预后，能针对性指导生物靶向药物的个体化精准治疗。常见的表型包括：1、早发过敏性哮喘 2、晚发持续性嗜酸粒细胞性哮喘 3、持续气流受限性哮喘 4、频繁急性发作性哮喘 5、肥胖相关性哮喘 1.早发过敏性哮喘:起病年龄是成人哮喘表型的良好识别标志。早发过敏性哮喘虽然缺乏确切年龄界限，但儿童期起病的成人哮喘患者多属于此表型。患者多有过敏性鼻炎、过敏性皮炎等过敏性疾病史及家族史，皮肤点刺试验阳性;一般对糖皮质激素具有良好反应性。2型炎症因子如IL-4、IL-5、IL-13水平及2型炎症生物标志物如诱导痰嗜酸粒细胞、呼出气一氧化氮(FeNO)、血清总lgE及骨膜素水平常升高，提示此类患者应用针对2型炎症的生物治疗可能获益。 2.晚发持续嗜酸粒细胞性哮喘:此类患者成年起病，起病时往往病情较严重，多合并鼻窦炎、鼻息肉、肥胖、GERD、糖尿病等。既往吸烟史与重度哮喘嗜酸粒细胞性气道炎症的激活有关。虽然缺乏过敏性疾病病史，但2型炎性介质水平可有升高，多与鼻息肉等合并疾病相关。此类患者经常表现出“激素抵抗"，其中既往吸烟史与对激素相对不敏感有关，但给予全身激素治疗后，大部分患者的临床症状、肺功能仍可以得到显著改善，应用糖皮质激素仍可获益。与儿童早发起病患者相比，成人晚发起病哮喘患者的哮喘发作更频繁，症状负担更重，需要使用更多的哮喘药物。 3.频繁急性发作性哮喘:该表型患者多有吸烟、更差的哮喘控制水平、更低的生活质量、高FeNO水平、高痰/血嗜酸粒细胞水平、更快的肺功能减损及更多ICS使用。此种表型即以往所提的脆性哮喘，一般可以分为两种类型。I型一般是指在尽管应用大剂量ICS，但仍存在较大的呼气峰值流速变异率(>40%)，常见于15~55岁女性患者，多有过敏疾病病史及皮肤点刺试验阳性。II型一般是指在哮喘控制良好的情况下，无明显先兆突然急性发作，并迅速进展、威胁生命。早期识别这两类哮喘患者，有效判断急性发作风险及进行哮喘患者教育，如避免过敏原接触，以及掌握基本的急救措施等对防治具有重要意义。 4.持续气流受限性哮喘:此种表型的哮喘患者肺功能损害更显著，更易发展为“固定的"或"持续存在的"气流受限，慢阻肺风险增高。其危险因素包括:早产、幼年体重异常、成年起病，男性、吸烟史、职业接触，哮喘急性加重而缺乏充分的ICS治疗，第一秒用力呼气容积(FEV1)基线水平低，慢性黏液高分泌状态以及持续的血、痰嗜酸粒细胞增加。同时，炎症生物标志物如痰液中高骨膜素和MMP-9水平可能与之相关。此表型患者高分辨率CT(HRCT)可表现为支气管壁厚度增加及肺气肿特征，但肺气肿发生率显著低于慢阻肺患者。激素使用更多(包括口服激素)，常规支气管扩张药物难以完全缓解病情。目前推荐采用以ICS、LABA、LAMA为基础的联合治疗方案。另外IL-4 [211]、IL-5[212]、TGF-β等生物治疗也逐渐受到关注。 5.肥胖相关性哮喘:肥胖被认为是哮喘的危险因素，其影响哮喘气道炎症及控制水平。在重度哮喘中，肥胖患者相对于正常体重者，肺功能如用力肺活量(FVC)下降更显著，更容易合并湿疹、GERD，而少有鼻息肉病史。随着BMI升高，FeNO、血嗜酸粒细胞水平和血清总lgE水平较前下降。同时，肥胖患者对全身激素及日需短效2受体激动剂的药物依赖性更强。常见內型：2型炎症哮喘、非2型炎症哮喘。 1.2型哮喘:是重度哮喘的主要内型，该类患者可具有一个或多个以下特征:(1)痰嗜酸性粒细胞≥2%;(2)血嗜酸粒细胞≥150个/ul;(3)FeNO≥20ppb;(4)具有过敏临床特征;(5)血清lgE升高;(6)糖皮质激素治疗反应好。2型哮喘主要由Th2淋巴细胞和ILC2活化所介导。病理特征主要表现为气道上皮功能障碍、气道炎症、黏液分泌、气道平滑肌收缩以及气道重塑。糖皮质激素可改善哮喘患者2型炎症。从2019年开始，2型炎症概念写入GINA指南，成为指导哮喘患者生物制剂使用的重要参考，目前许多生物制剂已被评估为2型哮喘有效的治疗方法，如抗lgE单抗(奥马珠单抗)、抗IL-5单抗(美泊利珠单抗)、抗IL-5R单抗(本瑞利珠单抗)、抗IL-4R单抗(度普利尤单抗)，抗胸腺基质淋巴细胞生成素单抗(抗TSLP单抗)。临床上常见的2型哮喘有早发过敏性哮喘、晚发持续嗜酸粒细胞哮喘、AERD。 2.非2型哮喘:此类患者常定义为缺乏2型炎症的哮喘。非2型哮喘主要涉及获得性免疫和固有免疫反应失调、中性粒细胞炎症、NLRP3炎症小体和IL-17通路的激活和神经免疫机制。病理特征亦可表现为气道上皮功能障碍、气道炎症、气道重塑。在此类重度哮喘患者中，HRCT可表现为支气管壁增厚、支气管扩张及肺气肿等。通常表现为发病年龄较晚，女性，肥胖，使用高剂量糖皮质激素，也有报道非2型哮喘患者支气管舒张反应性更差常与吸烟、细菌感染、肥胖和维生素D缺乏有关。也可见于少粒细胞性炎症和轻度气流受限的哮喘。非2型哮喘也可区分为中性粒细胞型、气道重塑型和糖皮质激素不敏感型;针对非2型重症患者治疗，目前主要采取的策略包括环境因素控制、减重、支气管热成形术、大环内酯类抗菌药物、抗胆碱能药物。一项临床试验提示抗TSLP单抗对非2型哮喘患者同样有效;另外，也有研究发现针对IL-33及其受体的生物制剂也能使非2型哮喘患者获益。而其他针对IL-17、IL-6、TNF-a等生物制剂仍在研究阶段。因此，寻找更有效的非2型哮喘的生物标志物和干预策略是未来研究的一个重要领域。重度哮喘的治疗原则：一、教育与管理：目的是提高患者对治疗的依从性，使其掌握正确的吸入装置使用方法，并提高自我管理水平。二、环境控制：有效减少或避免过敏原，减少和避免空气中有害刺激因子、戒烟。三、常规药物治疗： 1.糖皮质激素:重度哮喘患者常需要给予高剂量ICS或ICS联合口服糖皮质激素(OCS)治疗。(1)ICS:一般而言，哮喘患者ICS剂量越大，抗炎作用越强，但需注意过高的ICS剂量不能额外获益，甚至带来ICS相关不良反应。根据2023版GINA，常用高剂量ICS的定义如表。对于激素依赖性哮喘患者，吸入高剂量激素可减少OCS维持剂量。ICS规范使用可显著改善轻至中度哮喘患者2型炎症，但重度哮喘患者的2型炎症可能表现为对高剂量ICS相对耐受。近期有学者通过检测用药后的血清ICS水平变化评估重度哮喘患者用药依从性，发现血清低ICS水平与患者更高的急性发作频率以及更差的肺功能相关。高剂量ICS使用可能引起声音嘶哑、咽部不适和口腔念珠菌感染，尤其是吸入技术掌握不佳的患者。ICS剂量过大，也可能导致肾上腺抑制和儿童生长延迟等不良反应。(2)OCS:对于已经使用高剂量ICS+LABA维持治疗，症状仍未控制的重度哮喘患者可以加用OCS治疗，一般选用半衰期较短的激素(如泼尼松等)，采取小剂量、短疗程方案，不推荐长期使用，长期低剂量OCS仅在无其他替代方案时作为最后的选择。对于确需长期OCS患者，应确定最低维持剂量，泼尼松的最低维持剂量建议≤10mg/d，也有少数患者可能需要用到15mg/d的维持剂量。有学者建议采用2型生物标志物指导OCS的临床应用。2023年的一项研究证明，基于血嗜酸性粒细胞(EOS)计数和FeNO的生物标志物管理，尽管OCS用量未见减少，但年急诊就诊率得到显著改善，值得临床关注。长期使用OCS可增加不良反应的发生，包括肥胖、糖尿病、骨质疏松、青光眼、高血压及肾上腺功能抑制，也与焦虑、抑郁和睡眠障碍有关。因此，长期使用OCS和高剂量ICS时，应对患者的体重、血压、血糖、眼、骨密度和哮喘儿童的生长状况进行监测，同时需注意评估患者是否存在肾上腺机能不足。临床应积极寻找减少OCS使用的策略。(3)肌内注射长效激素:肌内注射长效激素曲安西龙3ml可用于治疗激素不敏感性重度哮喘患者。但是，鉴于其对于肾上腺皮质功能的抑制和使患者易于产生依赖性的不良反应，不推荐使用。 2.β受体激动剂:β2受体激动剂应与ICS联合使用，单独应用过多β2受体激动剂与哮喘急性加重及死亡风险增加有关。持续静脉滴注特布他林有助于减少重度哮喘的发作和住院次数，但因全身不良反应发生率较高，不推荐使用。对于某些致死性发作性哮喘患者可以通过预冲式注射器自我注射肾上腺素，但在β2受体激动剂治疗的基础上肌内注射肾上腺素是否可以进步改善预后，尚需进一步研究。 3.ICS+LABA复合制剂:重度哮喘的治疗中，LABA联合ICS的复合制剂的疗效明显优于单药在联合LABA的基础上逐步增加ICS剂量可能会进一步改善哮喘的控制。目前在我国临床上应用的ICS+LABA复合制剂有布地奈德/福莫特罗、氟替卡松/沙美特罗、丙酸倍氯米松/福莫特罗和糠酸氟替卡松/维兰特罗。一些每日仅需1次给药的LABA，例如茚达特罗(Indacaterol)、卡莫特罗(Carmoterol)、奥达特罗(Olodaterol)等和ICS组成的复方制剂也已经进入市场。 4.抗胆碱能药物:短效抗胆碱药异丙托溴铵气雾剂可减轻重度哮喘患者的气喘症状，并减少β2受体激动剂过量使用。许多重度哮喘患者尽管接受ICS+LABA治疗，仍存在持续的气流受限。对于已经使用中-高剂量ICS联合LABA的重度哮喘患者，添加LAMA噻托溴铵可减少气体陷闭，减少急性加重频率和改善肺功能。其他可以选择的LAMA包括每日1次给药的格隆溴铵(glycopyrrolate)和乌美溴铵(umeclidinium)以及每日2次给药的阿地溴铵(aclidinium bromide). 5.ICS+LABA+LAMA复合制剂:对常规ICS+LABA治疗控制不佳的患者可选择ICS+LABA+LAMA三联制剂，包括糠酸莫米松+茚达特罗+格隆溴铵粉雾剂、糠酸氟替卡松+维兰特罗+乌美溴铵粉雾剂、布地奈德+福莫特罗+格隆溴铵气雾剂和丙酸倍氯米松+富马酸福莫特罗+格隆溴铵气雾剂。目前我国糠酸莫米松+茚达特罗+格隆溴铵粉雾剂已获批用于哮喘治疗。更早地使用三联制剂可能有助于改善重度哮喘患者的肺功能和气道炎症，减少急性加重频率。 6.茶碱:对于重度哮喘患者，茶碱联合ICS治疗有助于哮喘症状的控制。对于吸烟伴激素不敏感的哮喘患者，茶碱联合低剂量ICS可明显提高呼气峰流速和哮喘控制程度。但该药在重度哮喘中地位不高。生物制剂：近年已经有四类用于哮喘治疗的生物制剂获批上市，分别是抗lgE、抗IL-5/IL-5受体(IL-5R)，抗IL-4受体(IL-4R)和抗TSLP单抗，这些生物制剂主要针对2型重度哮喘。GINA推荐这些生物制剂作为附加治疗用于经第4级治疗仍不能控制的重度哮喘。在我国也已经有奥马珠单抗、度普利尤单抗和美泊利珠单抗上市。五其他药物：大环内酯类抗菌药物、抗真菌药物、免疫抑制剂和抗代谢药物。 1.大环内酯类抗菌药物:有研究报告，口服小剂量大环内酯类抗菌药物(如阿奇霉素、克拉霉素等)可减轻中性粒细胞为主的气道炎症，降低气道高反应性，有助于重度哮喘的治疗。2020年ATS和ERS重度哮喘诊治指南建议在第5级治疗仍未控制的成人哮喘患者中考虑添加大环内酯类药物治疗，以减少哮喘急性发作;但对于儿童和青少年患者不建议长期使用大环内酯类药物治疗。2023年GINA提出对于高剂量ICS+LABA维持治疗仍有持续症状的成人哮喘患者可考虑使用阿奇霉素(每周3次)，建议疗程至少6个月。亦有报道小剂量阿奇霉素(0.25，3次/周)治疗半年显著改善哮喘合并支气管扩张的发作频率。但长期使用大环内酯类药物可能导致腹泻、QT间期延长、听力减退等不良反应及耐药的产生，使用前需请专科医师评估，并在用药过程中加强监测。 2.抗真菌药物:抗真菌药物主要用于伴有ABPA且反复发作的重度哮喘患者，可减少急性发作风险和改善症状，常用抗真菌药物包括伏立康唑和伊曲康唑。对于皮肤点刺试验或血清真菌特异gE阳性，但不合并ABPA的重度哮喘患者不推荐使用抗真菌药，主要考虑到抗真菌药与其他药物之间的相互作用、药物不良反应、医疗费用的增加以及其临床获益的不确定性。尽管如此，针对真菌致敏性重度哮喘 (severe asthma with fungal sensitization,SAFS)，如症状持续在专科指导下，可以尝试抗真菌治疗，这方面还需要更多的临床证据。另外，吸入性抗真菌药物具有较好的耐受性，目前正在研发中，可能有一定的应用前景。 3.免疫抑制剂和抗代谢药物:在一项针对重症嗜酸粒细胞性哮喘研究中，15%(9/61)的患者对甲氨蝶呤治疗有反应，可以显著减少OCS的剂量，平均从15mg/d降到6.25mg/d，但对肺功能、哮喘控制水平及痰嗜酸粒细胞炎症无明显影响。有病例报道显示，硫唑嘌呤可以减少重度哮喘患者口服激素剂量，从60mg/d到5mg/d、减少哮喘急性发作频率和改善肺功能。这些药物具有一定的不良反应，只能在专科医师指导下使用。属于此类的其他药物包括氨苯砜、秋水仙碱、羟氯喹和环孢素A等。由于缺乏高级别循证医学研究证据，这些药物的疗效和安全性尚不明确，不推荐使用。六、支气管热成形术：BT是一项在支气管镜介导下进行的非药物治疗技术，能够减少气道平滑肌(ASM)的数量、降低ASM收缩力改善哮喘控制水平、提高患者生活质量并减少哮喘药物的使用。目前有关BT作用机制的研究结果显示，BT还具有改变气道上皮功能、减少成纤维细胞重构、降低腺体黏液分泌、减轻气道炎症反应、减少细胞外基质及胶原沉积、减弱支气管神经反射及改善小气道功能等多种作用。

100 项与糠酸氟替卡松相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D06315	糠酸氟替卡松	R03BA09 R01AD12	DB08906

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
哮喘	美国	GlaxoSmithKline Intellectual Property Development Ltd.	2014-08-20
慢性阻塞性肺疾病	澳大利亚	GSK Plc	2014-04-17
常年性变应性鼻炎	加拿大	GSK Plc	2007-10-22
季节性过敏性鼻炎	加拿大	GSK Plc	2007-10-22
过敏性鼻炎	中国	Glaxo Wellcome UK Ltd.	2000-06-16

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
气管炎	临床3期	丹麦	GSK Plc	2015-07-03
呼吸困难	临床3期	意大利	GlaxoSmithKline Research & Development Ltd.	2011-04-18
纵隔疾病	临床3期	意大利	GlaxoSmithKline Research & Development	2011-03-08
僵硬	临床3期	挪威	GlaxoSmithKline Research & Development Ltd.	2011-03-03
心血管疾病	临床3期	美国	GSK Plc	2011-01-25
心血管疾病	临床3期	中国	GSK Plc	2011-01-25
心血管疾病	临床3期	日本	GSK Plc	2011-01-25
心血管疾病	临床3期	阿根廷	GSK Plc	2011-01-25
心血管疾病	临床3期	澳大利亚	GSK Plc	2011-01-25
心血管疾病	临床3期	奥地利	GSK Plc	2011-01-25

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临床结果

适应症

分期

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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


ATS2025	临床3期	哮喘 \| 炎症维持 blood eosinophils \| fractional exhaled nitric oxide	-	Fluticasone Furoate/Umeclidinium/Vilanterol	積繭繭艱製積齋壓衊餘(鏇積鏇獵醖夢衊艱顧願) = 憲鏇餘衊廠鹽鬱壓廠齋製製膚壓鬱糧範獵鹽壓 (齋蓋顧餘窪憲淵遞觸廠 )	-	2025-05-16
				Fluticasone Furoate/Vilanterol	積繭繭艱製積齋壓衊餘(鏇積鏇獵醖夢衊艱顧願) = 餘淵製餘獵願襯觸網憲製製膚壓鬱糧範獵鹽壓 (齋蓋顧餘窪憲淵遞觸廠 )
ATS2025	临床3期	慢性阻塞性肺疾病	4,151	Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)	願簾夢選鏇膚願選觸壓(範衊窪蓋廠積齋築糧製) = 觸醖膚淵鑰廠積膚積繭構壓憲遞網窪鏇憲鬱鑰 (繭製網壓鬱鹹醖築蓋齋 ) 更多	积极	2025-05-16
				Fluticasone Furoate/Vilanterol (FF/VI)	願簾夢選鏇膚願選觸壓(範衊窪蓋廠積齋築糧製) = 夢糧鏇遞膚繭獵製夢廠構壓憲遞網窪鏇憲鬱鑰 (繭製網壓鬱鹹醖築蓋齋 ) 更多
ATS2025	临床3期	哮喘	-	FF/VI 100/25	網窪繭網鹹簾襯構膚憲(構鹹鏇願範憲鑰鬱膚築) = 鬱齋齋構製窪廠遞鹹築願鑰膚網鬱憲繭網網鏇 (夢齋繭積觸淵鹽鏇願餘 )	积极	2025-05-16
				FF/VI 200/25	網窪繭網鹹簾襯構膚憲(構鹹鏇願範憲鑰鬱膚築) = 獵淵壓憲廠顧憲壓膚夢願鑰膚網鬱憲繭網網鏇 (夢齋繭積觸淵鹽鏇願餘 )
ELLITHE (ERS2024)	N/A	慢性阻塞性肺疾病	617	Fluticasone furoate+Umeclidinium+Vilanterol	衊繭遞鏇範鹹壓蓋壓構(鹹觸廠繭範鹽蓋願醖繭) = 獵齋鹽簾窪襯糧蓋選鑰觸積範顧鹹構顧觸範鏇 (遞夢觸繭淵鏇簾簾襯壓 ) 更多	积极	2024-09-07
TARhiC (AAAAI2024)	N/A	常年性变应性鼻炎维持	87	Fluticasone propionate/azelastine (FP/Aze 50/137 μg each nostril twice daily)	餘鬱繭範願淵築廠艱顧(鹽蓋積積選鹹構齋鹽築): mean difference = 1.26 (95% CI, 0.59 ~ 1.93), P-Value = <0.001	积极	2024-02-23
				Fluticasone furoate (FF 55 μg each nostril once daily)
ATS2023	N/A	哮喘	-	Fluticasone Furoate/Vilanterol	窪遞構鏇齋簾鹹鹽積齋(糧積築選簾觸範壓鹹醖) = Similar proportions of participants experienced ≥1 on-treatment adverse event (AE) in both populations (5-17 year-olds: n=181/454 [40%] receiving FF/VI versus n=163/448 [36%] receiving FF; 5-11 year-olds: n=133/337 [39%] receiving FF/VI versus n=122/336 [36%] receiving FF) 衊觸淵選製艱網鹹鏇壓 (鏇淵壓簾廠觸衊廠範鹽 )	-	2023-05-21
NCT05736874 (CTgov)	临床3期	新型冠状病毒感染	1,407	Fluticasone (Arm C - Fluticasone)	鏇夢襯鑰顧鑰顧網網鏇(鏇齋鏇顧選艱醖膚積積) = 網鬱膚觸製糧鹹構鑰積夢廠顧選襯鹽壓簾製鬱 (選獵憲簾淵襯範憲範憲, 遞醖艱範齋獵網壓鹽廠 ~ 選襯願襯憲衊艱鹹餘齋) 更多	-	2023-04-12
				Placebo (Arm C - Placebo)	鏇夢襯鑰顧鑰顧網網鏇(鏇齋鏇顧選艱醖膚積積) = 衊觸蓋繭鬱積遞範構淵夢廠顧選襯鹽壓簾製鬱 (選獵憲簾淵襯範憲範憲, 壓繭選醖鬱網繭鹹遞範 ~ 鹽遞鑰繭衊衊製鬱窪鹽) 更多
NCT02889809 (114971, CTgov)	临床4期	哮喘 \| 儿童哮喘	477	Placebo+Montelukast	願顧網淵觸壓顧餘築膚(廠膚淵艱構襯廠遞製蓋) = 鬱範鏇鹽簾構製獵膚齋願廠齋鏇壓遞鬱夢鏇鹽 (顧憲簾網製憲製窪壓繭, 0.1090) 更多	-	2022-01-04
NCT01279057 (CTgov)	临床3期	季节性过敏性鼻炎	727	Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) (Test)	築鹹鹹鏇構壓醖餘構襯(艱獵蓋簾餘艱遞夢壓窪) = 衊築襯顧襯醖鏇鬱夢願膚襯壓鹹範鑰壓廠製範 (簾憲積廠鹽廠觸網觸鹽, 2.415) 更多	-	2021-02-03
				Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray (Reference)	築鹹鹹鏇構壓醖餘構襯(艱獵蓋簾餘艱遞夢壓窪) = 遞積餘鑰蓋簾鹽鬱壓網膚襯壓鹹範鑰壓廠製範 (簾憲積廠鹽廠觸網觸鹽, 2.409) 更多
NCT02164513 (IMPACT, Pubmed \| Am J Respir Crit Care Med)	临床3期	慢性阻塞性肺疾病	-	Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25µg	製鏇壓製鏇顧獵餘衊膚(觸範鏇顧繭鑰蓋製鹽糧): hazard ratio = 0.89 (95% CI, 0.67 ~ 1.16), P-Value = 0.387	积极	2020-06-15
				Fluticasone Furoate/Vilanterol 100/25µg