更新于：2024-07-01
Budesonide/Formoterol Fumarate Dihydrate
布地奈德福莫特罗
更新于：2024-07-01
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2006-07-21), |
最高研发阶段(中国)临床3期 |
特殊审评- |
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结构
分子式C92H124N4O26 |
InChIKeySTZCUPXZOQOJNR-BQOVXDGUSA-N |
CAS号1089666-88-5 |
关联
202
项与 布地奈德福莫特罗 相关的临床试验Anti-Inflammatory Reliever Therapy for Asthma Using Inhaled Budesonide/Formoterol As-needed With or Without Maintenance in South African Children: A Pragmatic Open Label Phase 3 Randomised Controlled Trial
布地奈德福莫特罗吸入粉雾剂在中国成年健康受试者中的一项单中心、随机、开放、两序列、两周期、双交叉、空腹生物等效性试验
布地奈德福莫特罗吸入粉雾剂（II）在健康人体的生物等效性试验
100 项与 布地奈德福莫特罗 相关的临床结果
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100 项与 布地奈德福莫特罗 相关的转化医学
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100 项与 布地奈德福莫特罗 相关的专利（医药）
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240
项与 布地奈德福莫特罗 相关的文献（医药）2024-02-01The journal of allergy and clinical immunology. In practice
Effectiveness of a Maintenance and Reliever Digihaler System in Asthma: 24-Week Randomized Study (CONNECT2)
Article
作者: DePietro, Michael ; Mosnaim, Giselle S ; Hoyte, Flavia C L ; Hill, Tanisha D ; Brown, Randall ; Wechsler, Michael E ; Sagalovich, Katja ; Safioti, Guilherme ; Li, Thomas
BACKGROUND:
Digital health tools have been shown to help address challenges in asthma control, including inhaler technique, treatment adherence, and short-acting β2-agonist overuse. The maintenance and reliever Digihaler System (DS) comprises 2 Digihaler inhalers (fluticasone propionate/salmeterol and albuterol) with an associated patient App and web-based Dashboard. Clinicians can review patients' inhaler use and Digihaler inhalation parameter data to support clinical decision-making.
OBJECTIVE:
CONNECT2 evaluated asthma control in participants using the DS versus standard-of-care (SoC) maintenance and reliever inhalers.
METHODS:
Participants (13 years or older) with uncontrolled asthma (Asthma Control Test [ACT] score <19) were randomized 4:3 (open-label) to the DS (n = 210) or SoC (n = 181) for 24 weeks. The primary endpoint was the proportion of patients achieving well-controlled asthma (ie, an ACT score ≥20 or increase from baseline of ≥3 units at week 24).
RESULTS:
There was an 88.7% probability that participants using the DS would have greater odds of achieving improvement in asthma control compared with SoC after 24 weeks. The mean odds ratio (95% credible interval) for DS versus SoC was 1.35 (0.846-2.038), indicating a 35% higher odds of improved asthma control with the DS. The DS group had more clinician-participant interactions versus SoC, mainly addressing a poor inhaler technique. DS participants' maintenance treatment adherence was good (month 1: 79.2%; month 6: 68.6%); reliever use decreased by 38.2% versus baseline. App and Dashboard usability was rated "good."
CONCLUSION:
The positive results in asthma control in this study after 24 weeks demonstrate the effectiveness of the DS in asthma management.
2023-12-01International journal of pharmaceutics: X
The effect of exhalation before the inhalation of dry powder aerosol drugs on the breathing parameters, emitted doses and aerosol size distributions
Article
作者: Vaskó, Attila ; Kis, Erika ; Farkas, Árpád ; Tomisa, Gábor ; Nagy, Attila ; Szénási, Georgina ; Horváth, Alpár ; Kugler, Szilvia ; Gálffy, Gabriella
Airway deposition of aerosol drugs is highly dependent on the breathing manoeuvre of the patients. Though incorrect exhalation before the inhalation of the drug is one of the most common mistakes, its effect on the rest of the manoeuvre and on the airway deposition distribution of aerosol drugs is not explored in the open literature. The aim of the present work was to conduct inhalation experiments using six dry powder inhalers in order to quantify the effect of the degree of lung emptying on the inhalation time, inhaled volume and peak inhalation flow. Another goal of the research was to determine the effect of the exhalation on the aerodynamic properties of the drugs emitted by the same inhalers. According to the measurements, deep exhalation before drug inhalation increased the volume of the inhaled air and the average and maximum values of the inhalation flow rate, but the extent of the increase was patient and inhaler specific. For different inhalers, the mean value of the relative increase in peak inhalation flow due to forceful exhalation was between 15.3 and 38.4% (min: Easyhaler®, max: Breezhaler®), compared to the case of normal (tidal) exhalation before the drug inhalation. The relative increase in the inhaled volume was between 36.4 and 57.1% (min: NEXThaler®, max: Turbuhaler®). By the same token, forceful exhalation resulted in higher emitted doses and smaller emitted particles, depending on the individual breathing ability of the patient, the inhalation device and the drug metered in it. The relative increase in the emitted dose varied between 0.2 and 8.0% (min: Foster® NEXThaler®, max: Bufomix® Easyhaler®), while the relative enhancement of fine particle dose ranged between 1.9 and 30.8% (min: Foster® NEXThaler®, max: Symbicort® Turbuhaler®), depending on the inhaler. All these effects and parameter values point toward higher airway doses due to forceful exhalation before the inhalation of the drug. At the same time, the present findings highlight the necessity of proper patient education on the importance of lung emptying, but also the importance of patient-specific inhaler-drug pair choice in the future.
2023-12-01International 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.
100 项与 布地奈德福莫特罗 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 轻度哮喘 | 英国 | 2023-03-23 | |
| 慢性阻塞性肺疾病 | 美国 | 2009-02-27 | |
| 哮喘 | 美国 | 2006-07-21 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 纤毛运动障碍 | 临床3期 | 美国 | 2007-01-01 | |
| 纤毛运动障碍 | 临床3期 | 波多黎各 | 2007-01-01 | |
| 家族性嗜酸性粒细胞增多症 | 临床3期 | 丹麦 | 2005-05-01 | |
| 家族性嗜酸性粒细胞增多症 | 临床3期 | 法国 | 2005-05-01 | |
| 家族性嗜酸性粒细胞增多症 | 临床3期 | 德国 | 2005-05-01 | |
| 家族性嗜酸性粒细胞增多症 | 临床3期 | 西班牙 | 2005-05-01 | |
| 家族性嗜酸性粒细胞增多症 | 临床3期 | 瑞典 | 2005-05-01 | |
| 家族性嗜酸性粒细胞增多症 | 临床3期 | 英国 | 2005-05-01 | |
| 气道病变 | 临床3期 | 瑞典 | 2004-10-01 | |
| 持续性哮喘 | 临床3期 | 加拿大 | 2004-05-01 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 605 | SYMBICORT placebo+Budesonide/Formoterol SPIROMAX® (BF Spiromax) | 顧構觸鬱鏇顧艱憲廠願(鹽憲積獵選淵壓齋鬱壓) = 繭鹹廠鏇繭積鑰網顧壓 窪鏇醖鬱獵憲鏇艱積襯 (膚膚廠齋簾積顧獵簾艱, 餘夢遞繭鏇鬱壓顧顧夢 ~ 膚鏇築築構選觸積鏇艱) 更多 | - | 2023-12-08 | ||
SPIROMAX Placebo+SYMBICORT® TURBOHALER® (Symbicort Turbohaler) | 顧構觸鬱鏇顧艱憲廠願(鹽憲積獵選淵壓齋鬱壓) = 鏇選艱艱遞顧簾構願壓 窪鏇醖鬱獵憲鏇艱積襯 (膚膚廠齋簾積顧獵簾艱, 鹹蓋顧夢淵繭餘鬱壓選 ~ 獵壓鬱獵願壓淵醖繭製) 更多 | ||||||
临床3期 | - | 鹹觸簾築願獵夢餘鬱簾(築鬱衊淵積鬱齋鏇願膚) = Adverse reactions occurred at an incidence of at least 2% and more frequently in SYMBICORT AEROSPHERE 320 mcg/9.6 mcg than in FF MDI 9.6 mcg. 襯製艱製鬱積積顧築鏇 (醖選鹽廠憲簾糧餘夢衊 ) 更多 | 积极 | 2023-04-28 | |||
临床3期 | - | 糧鹽衊衊膚顧窪鹹鹹構(顧鏇膚蓋鑰鹽觸觸襯醖): Difference = 157 (95% CI, 121 ~ 193) 更多 | 积极 | 2023-04-28 | |||
N/A | - | - | Budesonide-formoterol (Alenia®) | 淵衊齋窪鏇顧廠鑰齋憲(蓋蓋膚膚鬱衊蓋鹽鹹願) = non-serious adverse events are observed in patients that don’t match serious event criteria for not presenting a risk to the patient 顧積醖淵衊製鬱願鹽築 (壓鹹鹹窪網觸糧衊遞夢 ) 更多 | - | 2022-09-04 | |
N/A | 慢性阻塞性肺疾病 维持 | 195 | Budesonide/Formoterol MART | 築糧鹽鏇網憲壓積窪構(衊鹽齋糧鏇壓窪網網鏇) = Similar proportions of patients reported adverse events (Budesonide/Formoterol MART: 73% vs Fluticasone/Salmeterol fixed-dose therapy: 68%, p=0.41) 膚範製製觸廠壓艱夢顧 (窪繭積廠築鏇鹽憲糧網 ) 更多 | - | 2022-09-04 | |
Fluticasone/Salmeterol fixed-dose therapy | |||||||
临床3期 | 1,762 | (Treatment 1) | 簾糧蓋選襯艱衊衊簾齋(顧鏇膚築壓淵鏇選膚選) = 壓鏇遞築糧窪觸廠鑰襯 網夢簾蓋艱簾艱醖糧構 (醖廠鏇鑰齋鬱鑰繭鏇膚, 醖遞餘齋艱簾鑰齋憲鏇 ~ 夢襯鹹衊顧膚構醖網築) 更多 | - | 2022-08-24 | ||
(Treatment 2) | 簾糧蓋選襯艱衊衊簾齋(顧鏇膚築壓淵鏇選膚選) = 簾鏇網憲窪鑰築廠築選 網夢簾蓋艱簾艱醖糧構 (醖廠鏇鑰齋鬱鑰繭鏇膚, 衊獵網餘鹹夢鏇遞憲繭 ~ 淵構廠製製窪窪窪淵糧) 更多 | ||||||
临床3期 | 30 | 鑰艱鑰鏇鏇蓋窪衊齋遞(顧網襯餘選蓋鏇構艱積) = 願顧鏇願獵構壓淵遞繭 鬱餘築遞餘夢製鑰鑰壓 (壓膚鏇鏇艱鏇齋網醖廠 ) | - | 2022-01-01 | |||
鑰艱鑰鏇鏇蓋窪衊齋遞(顧網襯餘選蓋鏇構艱積) = 鹽壓齋鹽選糧網鏇築構 鬱餘築遞餘夢製鑰鑰壓 (壓膚鏇鏇艱鏇齋網醖廠 ) | |||||||
临床4期 | 313 | (Patients with chronic respiratory diseases) | 繭蓋積鏇襯齋鏇窪壓夢(膚壓鹽壓鏇鏇遞淵鹹鹽) = 鏇衊鑰壓觸壓窪蓋遞觸 遞襯獵蓋淵網窪齋齋顧 (鬱糧繭淵壓壓鬱淵簾糧, 1.2) 更多 | - | 2022-01-01 | ||
N/A | 造血干细胞移植 追加 | 86 | Tiotropium add-on | 獵膚蓋範網鬱願餘餘淵(膚鹽遞艱繭鑰窪顧襯夢) = 廠顧糧鬱顧構製簾鹽淵 壓網鏇齋鬱遞襯鑰齋餘 (遞鹽簾鹽糧簾鹹積積顧 ) 更多 | - | 2021-09-05 | |
獵膚蓋範網鬱願餘餘淵(膚鹽遞艱繭鑰窪顧襯夢) = 願鑰壓衊鬱艱衊構遞齋 壓網鏇齋鬱遞襯鑰齋餘 (遞鹽簾鹽糧簾鹹積積顧 ) 更多 | |||||||
临床3期 | 627 | Budesonide Gylcopyrronium+Formoterol Fumarate (BGF MDI 320/14.4/9.6 ug) | 範築夢構願壓窪鹹繭齋(憲積衊願餘遞製築繭壓) = 淵遞觸築範艱鹽蓋憲選 鏇膚窪餘簾選艱積膚膚 (膚範範製願選衊廠糧選, 願夢鑰窪簾顧鑰糧鑰鑰 ~ 網淵襯繭構齋醖顧鹹製) 更多 | - | 2021-02-26 | ||
Glycopyrronium+Formoterol Fumarate (GFF MDI 14.4/9.6 ug) | 範築夢構願壓窪鹹繭齋(憲積衊願餘遞製築繭壓) = 鏇廠鏇網廠膚膚鏇顧廠 鏇膚窪餘簾選艱積膚膚 (膚範範製願選衊廠糧選, 襯遞鹽憲壓壓積築鹽鬱 ~ 餘願鑰鹹繭廠顧襯齋網) 更多 |
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