A Randomized, Multicenter, Multiple-dose, Double-blind, Placebo-controlled, Parallel-group Design, Clinical Endpoint Bioequivalence Study to Evaluate the Therapeutic Equivalence and Safety of Fluticasone Furoate and Vilanterol Inhalation Powder 100 mcg/25 mcg (Sandoz) and BREO® ELLIPTA® (Fluticasone Furoate and Vilanterol Inhalation Powder) 100 mcg/25 mcg (GlaxoSmithKline) in Adult Participants With Asthma

This is a randomized, multi-center, multiple-dose, double-blind, placebo-controlled, Parallel group design, clinical endpoint bioequivalence study in adult participants with asthma.
The study design includes up to a 2-week Screening period, at least a 2-week Run-in period, a 4-week Treatment period, and a safety follow up call one week later.
Visit 1: Screening Visit 2: Run-in period: All eligible participants will enter a 2-week Run-in period in which training will be provided to the participants on the use of inhalers and participant diary.
Visit 3: Day 1: Randomization to one of the 3 treatment groups to receive one inhalation of the study medication quaque die (QD), in the morning, for 28 ± 2 days.
Visit 4: Day 28: EOT
Participants will be contacted one week after their last site visit for Safety follow-up via phone call (end of study). Participants will be instructed to refrain from taking their current inhaled asthma medications from the start of the Run-in period until the end of treatment (EOT) visit. They will be provided with a salbutamol/albuterol inhaler (rescue medication) for use on an as-needed basis during the entire study duration until the EOT visit.

开始日期2025-10-31

申办/合作机构

Sandoz Group AG

CTRI/2024/04/066334

/ Not yet recruiting临床4期IIT

A randomized controlled trial to compare safety and efficacy of inhalational long acting ß2 agonist Vilanterol with fluticasone furoate against Salmeterol with fluticasone furoate in adult patients with reversible obstructive airway disease. - NIL

开始日期2024-05-06

申办/合作机构-

CTRI/2024/03/064848

/ Not yet recruitingN/AIIT

A comparative study of Vilanterol/Fluticasone furoate with Formoterol/Budesonide in the management of stable bronchial asthma - nil

开始日期2024-04-10

申办/合作机构-

100 项与糠酸氟替卡松/三苯乙酸维兰特罗相关的临床结果

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100 项与糠酸氟替卡松/三苯乙酸维兰特罗相关的转化医学

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100 项与糠酸氟替卡松/三苯乙酸维兰特罗相关的专利（医药）

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项与糠酸氟替卡松/三苯乙酸维兰特罗相关的文献（医药）

2025-10-03·JOURNAL OF ASTHMA

Single-inhaler triple therapy improves small airway dysfunction in moderate to severe asthma and asthma-COPD overlap: a retrospective cohort study

Article

作者: Sakurai, Shogo ; Akamatsu, Taisuke ; Shirai, Toshihiro ; Fujita, Yumi

BACKGROUND:

Medium- or high-dose fluticasone furoate (FF)/vilanterol (VI)/umeclidinium (UMEC) is associated with an improvement in forced expiratory volume in one second (FEV1), a marker of large airway dysfunction. However, the effect of FF/VI/UMEC on small airway dysfunction (SAD) remains unknown.

OBJECTIVE:

To clarify the effect of FF/VI/UMEC on SAD in moderate to severe asthma and asthma-chronic obstructive pulmonary disease overlap (ACO) in a retrospective cohort study.

METHODS:

Subjects included 18 moderate to severe asthma and ACO patients who switched from inhaled corticosteroid/long-acting-β2 agonist (ICS/LABA) to FF/VI/UMEC. Asthma Control Test (ACT), Asthma Control Questionnaire (ACQ), blood eosinophil counts, total IgE, fractional exhaled nitric oxide, spirometry, and oscillometry were measured and compared before and after FF/VI/UMEC treatment.

RESULTS:

Markers of SAD, including forced vital capacity (FVC), forced expiratory flow at 25-75% of FVC, respiratory system reactance at 5 Hz (X5), resonant frequency, and low-frequency reactance area (AX), improved significantly after the induction of SITT, in addition to ACT, ACQ, FEV1, and FEV1/FVC. Improvements in FEV1, X5, and AX correlated with improvements in ACT, and improvements in FEV1 and FEV1/FVC correlated with improvements in ACQ.

CONCLUSION:

FF/VI/UMEC improved SAD, and its improvement was correlated with improved asthma control in moderate to severe asthma and ACO patients.

2025-01-01·RESPIRATORY MEDICINE

Particularities of deposition of two ICS-LABA fixed dose combination dry powder aerosol drugs in the airways of COPD patients

Article

作者: Gálffy, Gabriella ; Kis, Erika ; Ilyés, Norbert ; Sánta, Balázs ; Horváth, Alpár ; Böcskei, Renáta Marietta ; Farkas, Árpád ; Kovács, Tamás ; Bártfai, Zoltán ; Réti, Izolda ; Havadtői, Botond

The aim of this study was to analyse the effect of breathing parameters, age, gender and disease status on the lung doses of the two ICS + LABA fixed combination dry powder drugs. Breathing parameters of 113 COPD patients were measured while inhaling through emptied NEXThaler® and Ellipta® inhalers and the corresponding lung doses were calculated. Lung dose of Foster® NEXThaler® was superior to the lung dose of Relvar® Ellipta® in around 85 % of the patients. The average value of the ratio of bronchiolar to bronchial deposition fractions was 5.0 for Foster® NEXThaler® and 2.6 for Relvar® Ellipta®. Lung dose was sensitive to the inhalation parameters, such as peak inhalation flow, inhaled volume and breath-hold time. For both studied drugs the dose to the lungs was relatively high for moderate PIF values, but it declined for low (<35 L/min) and high (>95 L/min) PIFs. The lung dose increased by the increase of the inhaled volume, but saturated over 1.0 L of inhaled air. Longer breath-hold time led to higher lung deposition, but the dependence was drug-specific. FEV₁ (%) and FEV₁/FVC (%) did not influence the lung dose significantly (p = 0.05). Exacerbating patients had lower lung doses (28.8 ± 5.8 % for Foster® NEXThaler® and 23.7 ± 3.8 % for Relvar® Ellipta®) than their non-exacerbating counterparts (33.7 ± 6.1 % for Foster® NEXThaler® and for 24.9 ± 3.9 % for Relvar® Ellipta®). The exact clinical consequences of the differences between the deposition distributions of the two drugs could be assessed only by systematic clinical trials.

2023-12-01·International journal of pharmaceutics: X

The effect of lung emptying before the inhalation of aerosol drugs on drug deposition in the respiratory system

Article

作者: Kugler, Szilvia ; Farkas, Árpád ; Tomisa, Gábor ; Szénási, Georgina ; Nagy, Attila ; Füri, Péter ; Horváth, Alpár ; Varga, János

The amount of drug depositing in the airways depends, among others, on the inhalation manoeuvre and breathing parameters. The objective of this study was to quantify the effect of lung emptying before the inhalation of drugs on the lung doses. Thirty healthy adults were recruited. Their breathing profiles were recorded while inhaling through six different emptied DPI devices without breathe-out and after comfortable or forced exhalation. The corresponding emitted doses and aerosol size distributions were derived from the literature. The Stochastic Lung Model was used to estimate the deposited doses. In general, forceful exhalation caused increased flow rate and inhaled air volume. Increased flow rate led to the increase of the average lung dose for drugs with positive lung dose-flow rate correlation (e.g. Symbicort®: relative increase of 6.7%, Bufomix®: relative increase of 9.2%). For drugs with negative correlation of lung dose with flow rate (all the studied drugs except the above two) lung emptying caused increased (Foster® by 2.7%), almost unchanged (Seebri®, Relvar®, Bretaris®) and also decreased (Onbrez® by 6.6%) average lung dose. It is worth noting that there were significant inter-individual differences, and lung dose of each drug could be increased by a number of subjects. In conclusion, the change of lung dose depends on the degree of lung emptying, but it is also inhaler and drug specific. Forceful exhalation can help in increasing the lung dose only if the above specificities are taken into account.

项与糠酸氟替卡松/三苯乙酸维兰特罗相关的新闻（医药）

2025-10-23

·有驾

慢性阻塞性肺疾病新型吸入制剂的研发进展：聚焦用药依从性改善与治疗效果提升

慢性阻塞性肺疾病（COPD）是全球第三大死亡原因，吸入制剂因 “直接作用于靶器官、全身副作用少” 成为一线治疗手段，但传统吸入制剂（如短效单一制剂、复杂装置干粉吸入剂）存在用药依从性差（全球平均依从率＜50%）、肺部沉积率低（仅 10%-20%）、急性加重控制不足等局限，导致临床疗效未达预期。近年新型吸入制剂通过 “制剂设计革新 + 装置技术升级”，从 “长效化、复方化、智能化、靶向化” 四大方向突破，显著改善患者依从性与治疗结局。本文系统综述 COPD 新型吸入制剂的核心研发方向：①长效复方吸入制剂（LABA/LAMA、LABA/LAMA/ICS 三联制剂）通过减少给药频率、整合多靶点治疗提升依从性；②超细颗粒吸入制剂通过优化粒径（1-3 μm）提高肺部沉积率，增强疗效并降低全身副作用；③智能吸入装置结合传感器与 APP 实现用药监测与提醒，解决 “遗忘用药”“操作错误” 问题；④干粉吸入剂（DPI）改良与靶向递送制剂（如黏液溶解型、细胞靶向型）适配特殊人群（老年、重度 COPD 患者）并提升病变区域药物浓度。基于近年 Ⅲ 期临床试验数据（如 IMPACT、ETHOS 试验），从肺功能（FEV₁）、急性加重率、CAT 评分、用药依从率等维度评估疗效与依从性改善效果；最后指出当前研发存在的生产成本高、装置适配性不足、长期安全性数据缺乏等挑战，并展望 “个性化制剂”“生物制剂吸入化”“可降解装置” 等未来方向，为 COPD 吸入治疗的临床转化与规范应用提供循证依据。引言 COPD 以 “持续气流受限、气道慢性炎症、肺功能进行性下降” 为核心特征，2025 年全球患病人数预计超 3.8 亿，每年因急性加重导致的住院率达 15%-20%，死亡风险较稳定期升高 3-5 倍。吸入给药是 COPD 治疗的 “金标准”，其优势在于：药物直接作用于气道和肺部靶器官，局部药物浓度高（是口服制剂的 5-10 倍），全身暴露量低（全身副作用发生率＜5%），但传统吸入制剂的临床应用面临三大核心痛点：用药依从性极差：COPD 患者多为老年人群（≥60 岁），合并认知功能下降、手部协调能力减弱，传统装置（如压力定量气雾剂 pMDI 需同步按压与吸气，干粉吸入剂 DPI 需快速深吸气）的操作错误率达 40%-60%；且传统制剂多为 “短效单一成分”（如沙丁胺醇 pMDI，每日给药 3-4 次），患者遗忘用药率超 50%，最终导致规范治疗率不足 30%。肺部沉积效率低：传统吸入制剂的药物颗粒粒径多为 5-10 μm，仅 10%-20% 能沉积于小气道（直径＜2 mm）和肺泡区域，其余颗粒因惯性撞击沉积于口咽部（易引发声音嘶哑、口腔念珠菌感染）或随呼气排出，导致 “有效剂量不足”，FEV₁改善幅度仅为预期的 60%-70%。急性加重控制不足：COPD 急性加重（AECOPD）的核心诱因是气道炎症加剧与黏液高分泌，传统单一制剂（如仅含支气管扩张剂的 LABA）无法同时抗炎与改善黏液清除，导致患者每年急性加重次数达 1.5-2.5 次，严重影响生活质量与生存期。新型吸入制剂的研发以 “解决上述痛点” 为核心，通过制剂配方优化与装置技术创新，实现 “减少给药频率、提升肺部沉积、智能监测用药”，为 COPD 患者提供更高效、便捷的治疗方案。本文聚焦这些新型制剂的研发逻辑、临床证据与应用前景，为医学专业人士提供参考。一、COPD 新型吸入制剂的核心研发方向与技术突破（一）长效复方吸入制剂：从 “单药多次” 到 “多药一次”，提升依从性与疗效协同 COPD 的治疗需同时覆盖 “支气管扩张（缓解气流受限）、抗炎（控制气道炎症）、黏液调节（改善排痰）” 三大靶点，传统单药或短效复方制剂需多次给药，而长效复方制剂通过 “多靶点药物整合 + 延长作用时间”，实现 “每日 1 次给药”，显著降低用药负担，是当前研发的主流方向。 1. 双联长效复方制剂（LABA/LAMA）研发逻辑：LABA（长效 β₂受体激动剂，如茚达特罗、维兰特罗）通过激动 β₂受体舒张气道平滑肌，作用持续 12-24 小时；LAMA（长效抗胆碱能药物，如格隆溴铵、乌美溴铵）通过阻断 M₃受体抑制气道收缩，两者协同增强支气管扩张效果，且无明显副作用叠加。技术突破：采用 “共悬浮技术” 或 “脂质体包埋” 实现药物同步释放，避免单一成分提前失效。例如，茚达特罗 / 格隆溴铵干粉吸入剂（Ultibro® Breezhaler）通过 “超细颗粒共混”，使两种药物的肺部沉积率均达 25%-30%（传统单药 DPI 沉积率 15%-20%），且作用持续 24 小时，支持每日 1 次给药。临床证据：Ⅲ 期试验（TONADO 1/2）显示，COPD 患者使用茚达特罗 / 格隆溴铵（110/50 μg qd）治疗 24 周，FEV₁谷值较基线提升 156-187 mL，显著高于单药 LABA（102 mL）或 LAMA（98 mL）；急性加重率较安慰剂降低 31%，用药依从率达 72%（传统短效复方制剂依从率 45%）。 2. 三联长效复方制剂（LABA/LAMA/ICS）研发逻辑：在 LABA/LAMA 基础上加入 ICS（吸入性糖皮质激素，如糠酸氟替卡松、布地奈德），针对 COPD 患者的气道慢性炎症（嗜酸性粒细胞浸润），尤其适合 “频繁急性加重（每年≥2 次）、血嗜酸性粒细胞≥300/μL” 的患者，实现 “扩张气道 + 抗炎” 双重作用，减少急性加重风险。技术突破：采用 “压力定量气雾剂（pMDI）超细颗粒配方” 或 “干粉吸入剂多室储药设计”，确保三种药物同步均匀释放，肺部沉积率均达 20%-25%，且 ICS 的全身吸收量降低（血药浓度＜100 pg/mL），减少骨质疏松、血糖升高风险。临床证据：关键 Ⅲ 期试验（IMPACT）纳入 10355 例中重度 COPD 患者，对比糠酸氟替卡松 / 乌美溴铵 / 维兰特罗（FF/UMEC/VI，100/62.5/25 μg qd）与双联制剂（FF/VI、UMEC/VI）的疗效：FF/UMEC/VI 组 FEV₁谷值提升 181 mL，显著高于双联组（143-150 mL）；急性加重率较 FF/VI 组降低 15%，较 UMEC/VI 组降低 26%；用药依从率达 78%，因副作用停药率仅 5.2%（传统三联制剂停药率 8.5%）。（二）超细颗粒吸入制剂：提升肺部沉积率，增强疗效并减少副作用传统吸入制剂的药物颗粒粒径多为 5-10 μm，易沉积于口咽部，而超细颗粒制剂（粒径 1-3 μm）可随气流深入小气道（直径＜2 mm）和肺泡区域，肺部沉积率提升至 30%-40%，同时减少口咽部沉积导致的局部副作用（如声音嘶哑、口腔念珠菌感染发生率从 10%-15% 降至 3%-5%）。 1. 超细颗粒干粉吸入剂（DPI）技术突破：采用 “喷雾干燥 - 气流粉碎联用技术” 制备超细颗粒，同时添加 “载体表面改性剂”（如硬脂酸镁、卵磷脂），避免颗粒团聚，确保吸入时颗粒均匀分散。例如，超细颗粒茚达特罗 DPI（粒径 2.5 μm）通过 “多孔载体吸附” 技术，肺部沉积率达 38%，是传统茚达特罗 DPI（粒径 6 μm，沉积率 18%）的 2 倍以上。临床优势：针对 “小气道功能障碍为主” 的 COPD 患者（FEV₁/FVC＜70% 且小气道阻力＞2.5 kPa・s/L），超细颗粒制剂可显著改善小气道通气功能 ——Ⅲ 期试验显示，超细颗粒格隆溴铵 DPI 治疗 12 周，患者小气道阻力较基线降低 32%，显著高于传统颗粒组（18%）；CAT 评分（生活质量评估）降低 4.2 分，传统组降低 2.8 分。 2. 超细颗粒压力定量气雾剂（pMDI）技术突破：采用 “氢氟烷烃（HFA）作为抛射剂” 替代传统氟利昂，配合 “微喷嘴设计”（孔径 5-10 μm），使药物颗粒粒径控制在 1-2 μm，且喷射速度降低（＜10 m/s），减少颗粒在咽喉部的惯性撞击。例如，超细颗粒沙丁胺醇 pMDI（ProAir® Digihaler）的肺部沉积率达 35%，是传统沙丁胺醇 pMDI（沉积率 12%）的 2.9 倍。临床优势：适用于 “急性加重期快速缓解”，超细颗粒可快速到达小气道，缓解气流受限 ——Ⅱ 期试验显示，急性加重期患者使用超细颗粒沙丁胺醇 pMDI（100 μg）后，FEV₁在 5 分钟内提升 120 mL，显著快于传统 pMDI（10 分钟提升 90 mL）；且因全身吸收量减少，心悸发生率从 12% 降至 4%。（三）智能吸入装置：解决 “遗忘用药” 与 “操作错误”，提升用药依从性 COPD 患者的用药依从性差，70% 源于 “遗忘用药”（老年患者认知功能下降）和 “操作错误”（装置使用复杂），智能吸入装置通过 “传感器 + 无线通信 + APP” 实现用药监测、提醒与操作指导，是改善依从性的关键技术。 1. 智能干粉吸入装置（DPI）技术配置：内置蓝牙传感器、压力传感器与加速度传感器，可记录 “用药时间、吸入流速、吸入深度”，数据实时同步至患者 / 医护 APP；当患者遗忘用药时，APP 推送提醒（铃声 + 弹窗）；当吸入流速不足（＜30 L/min）或吸入时间过短（＜1 秒）时，装置灯光提示操作错误，并通过 APP 指导正确操作。代表产品：糠酸氟替卡松 / 乌美溴铵 / 维兰特罗智能 DPI（Ellipta® Smart）、茚达特罗 / 格隆溴铵智能 DPI（Breezhaler® Connect）。临床证据：一项多中心研究纳入 520 例老年 COPD 患者（≥65 岁），使用智能 DPI 治疗 6 个月：用药依从率从基线 42% 提升至 81%，操作错误率从 45% 降至 8%；急性加重率较传统 DPI 组降低 28%，CAT 评分降低 5.3 分（传统组降低 3.1 分）。 2. 智能压力定量气雾剂（pMDI）技术配置：在传统 pMDI 基础上加装 “剂量计数器 + 倾斜传感器”，记录每次按压是否与吸气同步（避免 “早按 / 晚按” 导致的药物浪费）；APP 可生成 “用药日历”，医护人员通过后台查看患者用药数据，及时干预不依从行为（如电话提醒、门诊指导）。临床优势：针对 “手部协调能力差” 的患者（如合并类风湿关节炎、脑卒中后遗症），智能 pMDI 的 “吸气 - 按压同步提示” 可使操作成功率从 55% 提升至 92%；一项队列研究显示，使用智能 pMDI 的患者，药物浪费率从 35% 降至 12%，每支药物的实际使用天数从 20 天延长至 28 天。（四）特殊人群适配制剂：针对老年、重度 COPD 患者的剂型改良 1. 易操作干粉吸入剂（DPI）研发逻辑：老年 COPD 患者（≥70 岁）多存在吸气力量不足（吸入流速＜60 L/min），传统 DPI 需高流速（≥60 L/min）才能有效释放药物，而改良型 DPI 通过 “低阻力气道设计”（气道阻力＜0.5 kPa・s/L），使患者在低流速（30-40 L/min）下仍能达到有效肺部沉积率（25%-30%）。代表产品：噻托溴铵低阻力 DPI（Spiriva® Respimat®），采用 “软雾技术” 替代传统干粉，喷射速度慢（0.8 m/s）、雾滴粒径小（2.9 μm），患者无需快速深吸气，只需缓慢平稳吸气即可，操作成功率达 95%（传统 DPI 成功率 62%）。 2. 黏液溶解型吸入制剂研发逻辑：重度 COPD 患者（FEV₁＜50% 预计值）常合并黏液高分泌与气道黏液栓塞，传统吸入制剂难以穿透黏液层到达气道壁，而黏液溶解型制剂通过添加 “黏液溶解剂”（如 N - 乙酰半胱氨酸、氨溴索）或 “渗透促进剂”（如吐温 80），降低黏液黏度（黏度降低 40%-50%），促进药物穿透。临床证据：氨溴索 / 沙丁胺醇复方吸入剂（250/100 μg bid）治疗重度 COPD 患者 12 周，患者痰液排出量较基线增加 60%，FEV₁提升 130 mL，急性加重率较沙丁胺醇单药组降低 33%；且因黏液清除改善，肺部感染发生率从 22% 降至 10%。二、新型吸入制剂的临床疗效与用药依从性评估基于近年 15 项多中心 Ⅲ 期临床试验（累计纳入 38200 例 COPD 患者），从 “疗效指标”“依从性指标”“安全性指标” 三个维度，对比传统与新型吸入制剂的优势，核心数据如下：（一）疗效指标对比（二）用药依从性指标对比用药依从率：新型制剂（长效复方 + 智能装置）的依从率达 72%-81%，显著高于传统制剂（35%-45%，P＜0.001）；其中，智能装置的 “提醒功能” 可使遗忘用药率从 50% 降至 15%，“操作指导” 可使操作错误率从 40% 降至 8%。治疗持续性：新型制剂的 6 个月治疗持续率达 85%-90%，传统制剂为 55%-65%（P＜0.001）；主要原因是新型制剂的给药频率低（每日 1 次 vs 每日 3-4 次）、副作用少（全身副作用发生率 5%-8% vs 10%-15%）。（三）安全性指标局部副作用：超细颗粒制剂的口咽部沉积率低，声音嘶哑发生率 3%-5%（传统制剂 10%-15%），口腔念珠菌感染发生率 2%-4%（传统制剂 8%-12%）。全身副作用：长效复方制剂中 ICS 的剂量优化（如 FF 100 μg/qd），使骨质疏松发生率＜1%（传统 ICS 制剂 2%-3%），血糖升高发生率＜2%（传统制剂 4%-5%）。严重不良事件：新型制剂的严重不良事件发生率（5%-7%）与传统制剂（6%-8%）无显著差异（P＞0.05），主要不良事件为肺炎（发生率 3%-4%），但无证据显示新型制剂增加肺炎风险。三、当前研发挑战与未来展望（一）核心挑战生产成本与可及性：新型吸入制剂（尤其是智能装置与超细颗粒制剂）的生产成本较高（如智能 DPI 的单价是传统 DPI 的 2-3 倍），基层医院与低收入人群的可及性不足；且部分新型制剂依赖进口，国产化率低（仅 30%-40%），进一步推高用药成本。装置适配性与培训不足：虽智能装置简化了操作，但仍有 10%-15% 的老年患者（≥80 岁）因 “不会使用智能手机 APP” 无法享受智能功能；且临床医护人员对新型装置的培训不足，仅 40% 的医院开展系统的吸入装置操作培训，导致部分患者未能掌握正确使用方法。长期安全性数据缺乏：多数新型吸入制剂的临床试验随访周期为 6-12 个月，2 年以上的长期安全性数据（如超细颗粒制剂对肺组织的长期影响、智能装置的电池寿命与数据安全性）不足，限制了其在老年、合并多基础疾病患者中的广泛应用。特殊人群临床证据不足：针对 “极重度 COPD（FEV₁＜30% 预计值）”“合并支气管扩张症”“儿童 COPD” 的新型制剂临床试验较少，此类人群的用药方案仍依赖经验性调整，缺乏循证依据。（二）未来展望个性化吸入制剂研发：基于患者的 “肺功能分型（小气道障碍型 / 肺气肿型）”“炎症表型（嗜酸性粒细胞高 / 低）”“基因多态性（如 β₂受体基因型）”，开发 “定制化制剂”—— 例如，对 β₂受体 Arg16Gly 基因型患者，调整 LABA 剂量（增加 20%）以提升疗效；对小气道障碍型患者，优先使用超细颗粒制剂。生物制剂与吸入制剂的结合：将抗 IL-5、抗 IL-13 等生物制剂制成吸入制剂，直接作用于气道炎症部位，减少全身暴露量（如抗 IL-5 吸入制剂的血药浓度仅为静脉制剂的 1/10），当前临床前研究已显示抗 IL-5 吸入制剂可降低 COPD 患者的嗜酸性粒细胞计数（降低 60%），预计 5-8 年内进入 Ⅰ 期临床试验。可降解智能吸入装置：开发 “可降解聚合物材质” 的智能装置，避免传统塑料装置的环境污染；同时集成 “呼气末 CO₂监测” 功能，实时评估患者通气功能，动态调整用药方案（如通气功能恶化时，APP 提醒医生调整剂量）。真实世界研究与医保政策支持：开展大规模真实世界研究（样本量＞10 万例），评估新型吸入制剂在基层医院、老年人群中的疗效与安全性；推动新型制剂纳入国家医保目录，降低患者自付比例（从当前 50%-60% 降至 20%-30%），提升可及性。 COPD 新型吸入制剂通过 “长效复方化、超细颗粒化、智能装置化、特殊人群适配化” 的研发突破，显著解决了传统制剂 “依从性差、肺部沉积率低、急性加重控制不足” 的痛点 —— 长效复方制剂实现 “每日 1 次给药”，智能装置将依从率提升至 72%-81%，超细颗粒制剂使肺部沉积率达 30%-40%，临床数据显示 FEV₁改善幅度提升 50%-80%，急性加重率降低 26%-33%。当前需通过 “降低生产成本、加强医护培训、积累长期安全性数据” 推动临床转化，未来个性化制剂与生物制剂吸入化的发展，将进一步实现 COPD 的 “精准治疗”，为患者带来 “更好疗效、更低负担、更高生活质量” 的治疗结局。

临床3期临床结果

2025-10-20

·Business Wire

Innoviva Specialty Therapeutics Announces Oral Presentation Featuring New Analyses from the Zoliflodacin Pivotal Phase 3 Trial at IDWeek 2025

WALTHAM, Mass.--(BUSINESS WIRE)--Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (NASDAQ: INVA), will share new data on zoliflodacin during the Infectious Disease Society of America’s IDWeek 2025 annual meeting in Atlanta, GA, October 19-22, 2025. Zoliflodacin is a first-in-class oral antibiotic being developed for the treatment of uncomplicated gonorrhea. Three sets of data will be presented, including an oral presentation and two poster presentations: Poster Presentation P-1206 Date: Tuesday, October 21, 2025 Time: 12:15 PM - 1:30 PM ET Location: Poster Hall B4-B5 Title: Association of Sex Assigned at Birth and Sexual Orientation with Antimicrobial Susceptibility of Baseline Neisseria gonorrhoeae Isolates from Participants Recruited in the Global Zoliflodacin Phase 3 Randomized Controlled Trial Poster Presentation P-1207 Date: Tuesday, October 21, 2025 Time: 12:15 PM - 1:30 PM ET Location: Poster Hall B4-B5 Title: In Vitro Activity of Zoliflodacin against Neisseria gonorrhoeae Isolates Collected in 2022 from The United States Oral Presentation Date: Wednesday, October 22, 2025 Time: 1:45-3:00 Location: B211-B212 Title: Subgroup Analyses of Microbiological Cure Rates by Baseline Zoliflodacin MIC and Susceptibility to Ciprofloxacin in Participants from the Global Zoliflodacin Phase 3 Randomize Controlled Trial The oral presentation on Wednesday, October 22, describes key subgroup findings from the pivotal Phase 3 trial, including observation of high microbiological cure rates across urogenital, rectal, and pharyngeal sites in infection caused by Neisseria gonorrhoeae with a zoliflodacin MIC of ≤0.25 µg/mL. Among participants with urogenital infections who received zoliflodacin, ciprofloxacin-resistant strains had a cure rate of 96.6% (346/358; 95% CI: 94.2–98.3) and ciprofloxacin-susceptible strains had a cure rate of 97.4% (113/116; 95% CI: 92.6–99.5). High cure rates were consistent regardless of infection site. In poster P-1206 to be presented on Tuesday October 21, a demographic analysis of baseline isolates from the zoliflodacin Phase 3 trial found that while azithromycin resistance was higher in isolates from men who have sex with men (MSM), zoliflodacin MIC values were comparable across all patient groups, including females, MSM and heterosexual men (HSM). These findings underscore the in vitro activity of zoliflodacin across antibiotic-resistant N. gonorrhoeae from a broad range of sources and support the continued development of zoliflodacin as a single, oral dose treatment for uncomplicated gonorrhea. “Findings from our analyses reinforce our initial conclusions and support the development of zoliflodacin as a potentially transformative treatment for gonorrhea, including infections caused by resistant strains,” stated Dr. David Altarac, Chief Medical Officer of Innoviva Specialty Therapeutics. “Achieving high and consistent cure rates across urogenital and extra-genital sites, resistance profiles, and patient demographics represents a significant opportunity to address the growing global threat of antibiotic-resistant Neisseria gonorrhoeae.” Complementary analyses presented in poster P-1207 further support the potential of zoliflodacin as a broadly effective treatment for gonorrhea. In vitro susceptibility testing of Neisseria gonorrhoeae clinical isolates collected in the U.S. during 2022 confirmed that zoliflodacin potency remained consistent compared to prior surveillance years (2020–2021), including against antibiotic-resistant strains and isolates from both male and female patients. “The results from all three presentations show that zoliflodacin mechanism of action is differentiated from fluoroquinolones with cure rates remaining high in the face of antibiotic resistance,” said Dr. Sarah McLeod, Senior Director, Innoviva Specialty Therapeutics. About Zoliflodacin Zoliflodacin is an investigational, first-in-class oral antibiotic from the spiropyrimidinetrione class, currently in development as a single-dose treatment for uncomplicated gonorrhea, including strains resistant to current first-line therapies. Zoliflodacin inhibits bacterial DNA gyrase, an essential enzyme for bacterial survival. Zoliflodacin mechanism of action is distinct from that of currently approved antibiotics and has demonstrated activity against drug-resistant Neisseria gonorrhoeae. Non-inferiority was demonstrated in the global Phase 3 trial (NCT03959527) where a single oral dose of zoliflodacin was compared to ceftriaxone plus azithromycin for uncomplicated urogenital gonorrhea. This trial was sponsored by the Global Antibiotic Research and Development Partnership (GARDP). The U.S. FDA has granted zoliflodacin a Qualified Infectious Disease Product (QIDP) designation. This designation allows FDA Priority Review and Extended Market Exclusivity. Innoviva Specialty Therapeutics, Inc., anticipates that the NDA review will proceed according to the standard process for drugs with this designation. About Innoviva Specialty Therapeutics Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc., is focused on delivering innovative therapies in critical care and infectious disease. Innoviva Specialty Therapeutics’ products, through its affiliate, La Jolla Pharmaceutical Company, include GIAPREZA® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock, and XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. Innoviva Specialty Therapeutics’ products, through its affiliate, Entasis Therapeutics Inc., include XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). ZEVTERA® (ceftobiprole) is an FDA-approved cephalosporin specifically designed to treat adult patients with acute bacterial skin and skin structure infections (ABSSSI), adult patients with Staphylococcus aureus bloodstream infections (bacteremia) including those with right-sided infective endocarditis, and adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP). The Company’s clinical pipeline includes zoliflodacin, an investigational antibiotic for uncomplicated gonorrhea, which is being developed in collaboration with the Global Antibiotic Research and Development Partnership (GARDP), and is currently under review by the U.S. Food and Drug Administration. For more information about Innoviva Specialty Therapeutics, please visit here. Forward-Looking Statements This press release contains certain “forward-looking” statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, and future events. Innoviva intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. The words “anticipate”, “expect”, “goal”, “intend”, “objective”, “opportunity”, “plan”, “potential”, “target” and similar expressions are intended to identify such forward-looking statements. Such forward-looking statements involve substantial risks, uncertainties, and assumptions. These statements are based on the current estimates and assumptions of the management of Innoviva as of the date of this press release and are subject to known and unknown risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Innoviva to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: expected cost savings; lower than expected future royalty revenue from respiratory products partnered with GSK; the commercialization of RELVAR®/BREO® ELLIPTA®, ANORO® ELLIPTA® and, formerly, TRELEGY® ELLIPTA® in the jurisdictions in which these products have been approved; the strategies, plans and objectives of Innoviva (including Innoviva’s growth strategy and corporate development initiatives beyond the existing respiratory portfolio); the timing, manner, and amount of potential capital returns to shareholders; the status and timing of clinical studies, data analysis and communication of results; the potential benefits and mechanisms of action of product candidates; expectations for product candidates through development and commercialization; the timing of regulatory approval of product candidates; and projections of revenue, expenses and other financial items; the impact of the novel coronavirus (COVID-19). Other risks affecting Innoviva are described under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in Innoviva’s Annual Report on Form 10-K for the year ended December 31, 2022 and Quarterly Reports on Form 10-Q, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC’s website at www.sec.gov. Past performance is not necessarily indicative of future results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The information in this press release is provided only as of the date hereof, and Innoviva assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.

临床3期临床结果优先审批合格传染病产品申请上市

2025-10-20

·innovivaspecialtytherapeutics.com

Innoviva Specialty Therapeutics Announces Oral Presentation Featuring New Analyses from the Zoliflodacin Pivotal Phase 3 Trial at IDWeek 2025

Zoliflodacin, an investigational single-dose oral antibiotic for uncomplicated gonorrhea, to be featured in oral presentation with key subset analyses from pivotal global Phase 3 trial Waltham, MA – October 20, 2025 – Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (NASDAQ: INVA), will share new data on zoliflodacin during the Infectious Disease Society of America’s IDWeek 2025 annual meeting in Atlanta, GA, October 19-22, 2025. Zoliflodacin is a first-in-class oral antibiotic being developed for the treatment of uncomplicated gonorrhea. Three sets of data will be presented, including an oral presentation and two poster presentations: Poster Presentation P-1206 Date: Tuesday, October 21, 2025 Time: 12:15 PM – 1:30 PM ET Location: Poster Hall B4-B5 Title: Association of Sex Assigned at Birth and Sexual Orientation with Antimicrobial Susceptibility of Baseline Neisseria gonorrhoeae Isolates from Participants Recruited in the Global Zoliflodacin Phase 3 Randomized Controlled Trial Poster Presentation P-1207 Date: Tuesday, October 21, 2025 Time: 12:15 PM – 1:30 PM ET Location: Poster Hall B4-B5 Title: In Vitro Activity of Zoliflodacin against Neisseria gonorrhoeae Isolates Collected in 2022 from The United States Oral Presentation Date: Wednesday, October 22, 2025 Time: 1:45-3:00 Location: B211-B212 Title: Subgroup Analyses of Microbiological Cure Rates by Baseline Zoliflodacin MIC and Susceptibility to Ciprofloxacin in Participants from the Global Zoliflodacin Phase 3 Randomize Controlled Trial The oral presentation on Wednesday, October 22, describes key subgroup findings from the pivotal Phase 3 trial, including observation of high microbiological cure rates across urogenital, rectal, and pharyngeal sites in infection caused by Neisseria gonorrhoeae with a zoliflodacin MIC of ≤0.25 µg/mL. Among participants with urogenital infections who received zoliflodacin, ciprofloxacin-resistant strains had a cure rate of 96.6% (346/358; 95% CI: 94.2–98.3) and ciprofloxacin-susceptible strains had a cure rate of 97.4% (113/116; 95% CI: 92.6–99.5). High cure rates were consistent regardless of infection site. In poster P-1206 to be presented on Tuesday October 21, a demographic analysis of baseline isolates from the zoliflodacin Phase 3 trial found that while azithromycin resistance was higher in isolates from men who have sex with men (MSM), zoliflodacin MIC values were comparable across all patient groups, including females, MSM and heterosexual men (HSM). These findings underscore the in vitro activity of zoliflodacin across antibiotic-resistant N. gonorrhoeae from a broad range of sources and support the continued development of zoliflodacin as a single, oral dose treatment for uncomplicated gonorrhea. “Findings from our analyses reinforce our initial conclusions and support the development of zoliflodacin as a potentially transformative treatment for gonorrhea, including infections caused by resistant strains,” stated Dr. David Altarac, Chief Medical Officer of Innoviva Specialty Therapeutics. “Achieving high and consistent cure rates across urogenital and extra-genital sites, resistance profiles, and patient demographics represents a significant opportunity to address the growing global threat of antibiotic-resistant Neisseria gonorrhoeae.” Complementary analyses presented in poster P-1207 further support the potential of zoliflodacin as a broadly effective treatment for gonorrhea. In vitro susceptibility testing of Neisseria gonorrhoeae clinical isolates collected in the U.S. during 2022 confirmed that zoliflodacin potency remained consistent compared to prior surveillance years (2020–2021), including against antibiotic-resistant strains and isolates from both male and female patients. “The results from all three presentations show that zoliflodacin mechanism of action is differentiated from fluoroquinolones with cure rates remaining high in the face of antibiotic resistance,” said Dr. Sarah McLeod, Senior Director, Innoviva Specialty Therapeutics. About Zoliflodacin Zoliflodacin is an investigational, first-in-class oral antibiotic from the spiropyrimidinetrione class, currently in development as a single-dose treatment for uncomplicated gonorrhea, including strains resistant to current first-line therapies. Zoliflodacin inhibits bacterial DNA gyrase, an essential enzyme for bacterial survival. Zoliflodacin mechanism of action is distinct from that of currently approved antibiotics and has demonstrated activity against drug-resistant Neisseria gonorrhoeae. Non-inferiority was demonstrated in the global Phase 3 trial (NCT03959527) where a single oral dose of zoliflodacin was compared to ceftriaxone plus azithromycin for uncomplicated urogenital gonorrhea. This trial was sponsored by the Global Antibiotic Research and Development Partnership (GARDP). The U.S. FDA has granted zoliflodacin a Qualified Infectious Disease Product (QIDP) designation. This designation allows FDA Priority Review and Extended Market Exclusivity. Innoviva Specialty Therapeutics, Inc., anticipates that the NDA review will proceed according to the standard process for drugs with this designation. About Innoviva Specialty Therapeutics Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc., is focused on delivering innovative therapies in critical care and infectious disease. Innoviva Specialty Therapeutics’ products, through its affiliate, La Jolla Pharmaceutical Company, include GIAPREZA® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock, and XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. Innoviva Specialty Therapeutics’ products, through its affiliate, Entasis Therapeutics Inc., include XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). ZEVTERA® (ceftobiprole) is an FDA-approved cephalosporin specifically designed to treat adult patients with acute bacterial skin and skin structure infections (ABSSSI), adult patients with Staphylococcus aureus bloodstream infections (bacteremia) including those with right-sided infective endocarditis, and adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP). The Company’s clinical pipeline includes zoliflodacin, an investigational antibiotic for uncomplicated gonorrhea, which is being developed in collaboration with the Global Antibiotic Research and Development Partnership (GARDP), and is currently under review by the U.S. Food and Drug Administration. For more information about Innoviva Specialty Therapeutics, please visit here. Forward Looking Statements This press release contains certain “forward-looking” statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, and future events. Innoviva intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. The words “anticipate”, “expect”, “goal”, “intend”, “objective”, “opportunity”, “plan”, “potential”, “target” and similar expressions are intended to identify such forward-looking statements. Such forward-looking statements involve substantial risks, uncertainties, and assumptions. These statements are based on the current estimates and assumptions of the management of Innoviva as of the date of this press release and are subject to known and unknown risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Innoviva to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: expected cost savings; lower than expected future royalty revenue from respiratory products partnered with GSK; the commercialization of RELVAR®/BREO® ELLIPTA®, ANORO® ELLIPTA® and, formerly, TRELEGY® ELLIPTA® in the jurisdictions in which these products have been approved; the strategies, plans and objectives of Innoviva (including Innoviva’s growth strategy and corporate development initiatives beyond the existing respiratory portfolio); the timing, manner, and amount of potential capital returns to shareholders; the status and timing of clinical studies, data analysis and communication of results; the potential benefits and mechanisms of action of product candidates; expectations for product candidates through development and commercialization; the timing of regulatory approval of product candidates; and projections of revenue, expenses and other financial items; the impact of the novel coronavirus (COVID-19). Other risks affecting Innoviva are described under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in Innoviva’s Annual Report on Form 10-K for the year ended December 31, 2022 and Quarterly Reports on Form 10-Q, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC’s website at www.sec.gov. Past performance is not necessarily indicative of future results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The information in this press release is provided only as of the date hereof, and Innoviva assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law. Media Contact: David Patti Corporate Communications Innoviva, Inc. david.patti@inva.com Investor Contact: Eleanor Barisser Eleanor.barisser@inva.com

临床3期临床结果优先审批合格传染病产品上市批准

100 项与糠酸氟替卡松/三苯乙酸维兰特罗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	糠酸氟替卡松/三苯乙酸维兰特罗	R03AK10	-

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	GlaxoSmithKline KK	2016-12-02
肺气肿	日本	GlaxoSmithKline KK	2016-12-02
哮喘	日本	GlaxoSmithKline KK	2013-09-20
慢性阻塞性肺疾病	美国	Glaxo Group Ltd.	2013-05-10

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
短暂性脑缺血发作	临床3期	美国	GSK Plc	2012-04-01
短暂性脑缺血发作	临床3期	加拿大	GSK Plc	2012-04-01
短暂性脑缺血发作	临床3期	捷克	GSK Plc	2012-04-01
短暂性脑缺血发作	临床3期	德国	GSK Plc	2012-04-01
短暂性脑缺血发作	临床3期	波兰	GSK Plc	2012-04-01
短暂性脑缺血发作	临床3期	罗马尼亚	GSK Plc	2012-04-01
心肌梗塞	临床3期	美国	GSK Plc	2012-04-01
心肌梗塞	临床3期	加拿大	GSK Plc	2012-04-01
心肌梗塞	临床3期	捷克	GSK Plc	2012-04-01
心肌梗塞	临床3期	德国	GSK Plc	2012-04-01

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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


NCT04937387 (CTgov)	临床3期	哮喘	359	Fluticasone Furoate [FF]+Vilanterol [VI] (Fluticasone Furoate [FF] 100 Microgram[ug] / Vilanterol [VI] 25 ug)	築襯齋廠構構艱糧齋膚(壓選鹹壓簾淵淵鹹鏇鹽) = 蓋觸鹹鏇齋糧憲網製繭蓋繭鏇築構獵齋窪鏇選 (願顧醖遞顧顧膚築糧鑰, 0.0321) 更多	-	2025-08-11
				Fluticasone Furoate [FF]+Vilanterol [VI]+Umeclidinium [UMEC] (Fluticasone Furoate [FF] 100 ug/ Umeclidinium [UMEC] 62.5 ug/ Vilanterol [VI] 25 ug)	築襯齋廠構構艱糧齋膚(壓選鹹壓簾淵淵鹹鏇鹽) = 窪鬱鹽鏇積製鹽醖襯鹹蓋繭鏇築構獵齋窪鏇選 (願顧醖遞顧顧膚築糧鑰, 0.0316) 更多
ATS2025	N/A	哮喘	177	Vilanterol/Fluticasone Furoate (VI/FF) DPI	衊鑰鑰淵製醖顧鑰獵願(夢窪選選鹹淵繭憲積鹽) = 膚鹹選獵範襯構窪遞廠鬱鹹鹽廠網遞鹹淵鹽壓 (齋鏇衊範繭憲獵壓窪窪 ) 更多	积极	2025-05-16
ATS2023	N/A	哮喘	-	Fluticasone Furoate/Vilanterol	獵襯壓淵夢鏇襯網鏇鏇(鹽夢齋鑰壓鬱艱積製壓) = 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) 鹹窪糧廠壓製衊願獵顧 (壓鬱糧範憲構觸鬱醖艱 )	-	2023-05-21
ATS2022	N/A	慢性阻塞性肺疾病 \| 哮喘	3,426	Fluticasone furoate/vilanterol 100 µg/25 µg	顧衊築構積艱夢繭鑰觸(築廠積齋構選壓壓獵鹽) = 鹹壓獵醖衊顧廠範獵襯鏇糧鹽淵選鬱選憲積鬱 (鏇醖鹽顧簾醖憲選簾觸 ) 更多	积极	2022-05-15
				Fluticasone furoate/vilanterol 200 µg/25 µg	顧衊築構積艱夢繭鑰觸(築廠積齋構選壓壓獵鹽) = 鹽壓願鏇觸淵範選願願鏇糧鹽淵選鬱選憲積鬱 (鏇醖鹽顧簾醖憲選簾觸 ) 更多
NCT01551758 (HZC115151, Pubmed \| Ther Adv Respir Dis)	临床3期	慢性阻塞性肺疾病	2,802	Fluticasone furoate/vilanterol 100/25 µg	製憲淵糧繭艱願簾餘鹽(廠繭鹹艱艱糧遞淵繭積) = 鬱遞窪鏇簾鬱醖鏇艱顧醖繭糧獵糧觸積網鹹選 (襯繭願衊簾顧構築鏇製 ) 更多	-	2021-01-01
				fluticasone furoate/vilanterol	製憲淵糧繭艱願簾餘鹽(廠繭鹹艱艱糧遞淵繭積) = 築齋壓壓選簾鬱壓醖衊醖繭糧獵糧觸積網鹹選 (襯繭願衊簾顧構築鏇製 ) 更多
NCT03380429 (CTgov)	临床4期	哮喘	437	Relvar/Breo+salbutamol (Cohort 1: Data on Maintenance Use Supplied to Par and HCP)	積壓鹹醖選糧顧壓鬱糧(醖艱獵鏇構鬱壓遞簾膚) = 糧糧積積觸製遞範觸鬱膚範壓醖淵簾積築衊襯 (製遞積夢窪鑰鏇夢觸衊, 3.19) 更多	-	2020-02-05
				Relvar/Breo+salbutamol (Cohort 5: No Data Supplied to Par or HCP)	積壓鹹醖選糧顧壓鬱糧(醖艱獵鏇構鬱壓遞簾膚) = 築鹹夢願鏇窪醖廠築鬱膚範壓醖淵簾積築衊襯 (製遞積夢窪鑰鏇夢觸衊, 3.19) 更多
NCT01706198 (Asthma Salford Lung, Pubmed \| J Asthma)	临床3期	哮喘维持	4,233	Fluticasone furoate/vilanterol	願願選衊淵選鑰衊醖壓(淵構簾遞鬱構顧襯襯鏇) = 廠觸鏇齋獵艱鏇獵繭鹹襯齋製遞鬱製築蓋構夢 (糧製鬱餘願窪獵廠製齋 )	积极	2019-07-01
				Fluticasone propionate/salmeterol	願願選衊淵選鑰衊醖壓(淵構簾遞鬱構顧襯襯鏇) = 夢網範網壓憲遞積膚衊襯齋製遞鬱製築蓋構夢 (糧製鬱餘願窪獵廠製齋 )
NCT01957150 (CTgov)	临床4期	慢性阻塞性肺疾病	283	VI (Participants Administered VI)	獵鏇衊齋築鑰製選齋鏇(艱艱壓壓夢繭觸蓋壓獵) = 遞積膚艱顧簾網觸範衊襯選襯觸鹽鹽鏇遞觸糧 (製簾餘夢鑰鏇憲鹹餘網, 襯觸廠遞觸遞衊遞製簾 ~ 餘糧壓觸夢範願襯廠積) 更多	-	2019-04-10
				VI (Participants Administered FF/VI)	獵鏇衊齋築鑰製選齋鏇(艱艱壓壓夢繭觸蓋壓獵) = 壓鬱鬱窪廠願鑰襯齋壓襯選襯觸鹽鹽鏇遞觸糧 (製簾餘夢鑰鏇憲鹹餘網, 繭壓艱齋簾膚膚築鑰顧 ~ 獵願齋觸繭遞顧顧齋鑰) 更多
NCT01313676 (SUMMIT, Pubmed \| ERJ Open Res)	临床3期	慢性阻塞性肺疾病	-	Fluticasone furoate (FF)	觸鹽糧夢醖顧觸壓構製(鑰淵積淵廠願窪獵鹹積): hazard ratio = 0.65 (95% CI, 0.48 ~ 0.89)	-	2019-02-01
				Placebo
NCT01706198 (Salford Lung Study in Asthma \| Asthma Salford Lung \| SLS asthma, CTgov)	临床3期	哮喘	4,233	fluticasone furoate + vilanterol+inhaled corticosteroid with or without a long acting beta2-agonist	構膚糧範蓋鏇廠壓顧廠 = 鏇鏇鹹衊繭餘簾廠網鏇衊餘鬱蓋範膚顧構選壓 (網範艱壓窪鹹網齋窪壓, 製襯艱鑰遞構夢壓網遞 ~ 顧觸壓憲鏇鏇淵遞鹽簾) 更多	-	2019-01-24