预约演示
更新于：2025-04-14
Budesonide/Formoterol Fumarate Dihydrate
布地奈德福莫特罗
更新于：2025-04-14
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C92H124N4O26 |
InChIKeySTZCUPXZOQOJNR-BQOVXDGUSA-N |
CAS号1089666-88-5 |
关联
225
项与 布地奈德福莫特罗 相关的临床试验NCT06895460
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial on the Treatment of Bronchial Asthma With Budesonide Formoterol Combined With Immune Modulators (Staphylococcus and Neisseria Tablets)
NCT06597682
A Randomized Controlled Basket Study for Evaluating Immunomodulatory Interventions in Post-Acute Sequelae of SARS-CoV-2 InfEction (RISE)
NCT06676319
A Randomized, Phase 2, Double-blind, Placebo-controlled, Parallel-group, 2-arm Study to Investigate the Efficacy, Safety, and Tolerability of Subcutaneous Lunsekimig (SAR443765) in Adult Participants With High-risk Asthma Who Are Not Currently Eligible for Biologic Treatment
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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398
项与 布地奈德福莫特罗 相关的文献（医药）2025-04-03JOURNAL OF ASTHMA
Budesonide/formoterol turbuhaler vs pMDI salbutamol for acute asthma in outpatient emergency department: a prospective, randomized, open-label study
Article
作者: Mohd Pauzi, Zulsairi ; Chong, Woon Wee ; Lai, Sin Nan ; Koh, Hock Peng
BACKGROUND:
The Global Initiative for Asthma (GINA) has suggested the need for more studies on inhaled corticosteroid (ICS)-formoterol in the Emergency Department (ED).
OBJECTIVES:
We aimed to compare the outcomes of budesonide/formoterol (160/4.5 mcg/inhalation) turbuhaler versus pressurized metered-dose inhaler (pMDI) salbutamol (100 mcg/puff) in acute asthma in the outpatient ED.
METHODS:
This single-centre, prospective, randomized, and open-label study involved adult asthma patients with mild to moderate asthma exacerbation who attended the outpatient ED of a tertiary hospital in Malaysia. The intervention arm received budesonide/formoterol (Symbicort® 160/4.5 mcg) turbuhaler, while the control arm received pMDI salbutamol with a valved holding chamber. Stratified randomization with variable baseline ICS use was employed. Direct discharge rate from outpatient ED was the primary outcome. Vital signs pre- and post-treatment between the two arms were also compared.
RESULTS:
Seventy-four (n = 37 for each arm) asthma patients were recruited. Baseline clinical characteristics were comparable between the two arms. Direct discharge rates from ED were comparable between the intervention (94.6%) and the control (91.9%) arms (p = 1.000). Post-treatment outcomes (respiratory rate, oxygen saturation, peak expiratory flow rate) were similar between the two arms, except for the higher increment of heart rate (p < 0.001) and lesser reduction of blood pressure in the control arm (p = 0.013). Intravenous hydrocortisone use was significantly higher in the control arm (n = 19, 51.4%) than in the budesonide/formoterol arm (n = 6, 16.2%) (p = 0.001).
CONCLUSION:
Budesonide/formoterol turbuhaler is as effective as pMDI salbutamol in treating asthma exacerbation in the outpatient ED with less effect on heart rate and lower usage of intravenous corticosteroids.
2025-03-01Journal of Allergy and Clinical Immunology-In Practice
Long-Term Effectiveness of a Digital Inhaler on Medication Adherence and Clinical Outcomes in Adult Asthma Patients in Primary Care: The Cluster Randomized Controlled ACCEPTANCE Trial
Article
作者: Kocks, Janwillem W H ; Chavannes, Niels H ; Meijer, Eline ; Flokstra-de Blok, Bertine M J ; Postma, Maarten J ; van de Hei, Susanne J ; van Boven, Job F M ; Gerritsma, Yoran H ; Poot, Charlotte C ; van den Berg, Liselot N
BACKGROUND:
Digital inhalers can support medication adherence and asthma control in the short-term. Yet, long-term benefits are unknown.
OBJECTIVE:
To investigate the clinical effects, usability, and cost-effectiveness of a digital inhaler.
METHODS:
This was an open-label cluster randomized controlled trial of 12 months in Dutch primary care. Adults with suboptimal controlled asthma and nonadherence were eligible. General practices were randomly allocated to either intervention or control, stratified by practice size. Intervention and control patients received an electronic monitoring device attached to their budesonide/formoterol SYMBICORT Turbuhaler maintenance inhaler. Intervention patients used a smartphone application for data insights and reminders. Control patients' inhaler use was passively monitored. Primary outcome was 1-year medication adherence. Secondary outcomes included asthma control, quality of life, usability, and cost-effectiveness.
RESULTS:
Between June 27, 2019 and September 30, 2022, 136 clusters containing 164 participants were randomized (82 participants across 68 clusters in both groups). Estimated marginal means (EMM) for medication adherence were 71.4% (95% CI, 67.1-75.4) and 59.9% (95% CI, 55.0-64.7) in the intervention and control groups, respectively. Medication adherence was higher in the intervention group at week 2 (odds ratio [OR] = 2.19; 95% CI, 1.63-2.95). The difference in medication adherence between groups declined over time (P < .0001); no significant difference was found at study end (OR = 1.23; 95% CI, 0.91-1.66). Overall, Asthma Control Questionnaire-5 scores were significantly better (P = .0056) in the intervention group (EMM, 1.31; 95% CI, 1.18-1.44) compared with control (EMM, 1.56; 95% CI, 1.44-1.68). Quality of life (Mini Asthma Quality of Life Questionnaire scores) did not differ significantly between groups (P = .0530). However, the intervention group was almost three times more likely to reach the minimal clinically important difference for asthma-related quality of life (OR = 2.73; 95% CI, 1.02-7.54). Mean system usability score was 80.1 (SD, 13.8). Cost per 0.5-point Asthma Control Questionnaire-5 decrease was €278.
CONCLUSION:
Use of this digital inhaler led to significant improvements in medication adherence in the short term and to sustained improved asthma control over 12 months.
2025-02-01AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE
Effect of Triple Therapy on Cardiovascular and Severe Cardiopulmonary Events in Chronic Obstructive Pulmonary Disease: A Post Hoc Analysis of a Randomized, Double-Blind, Phase 3 Clinical Trial (ETHOS)
Article
作者: Arya, Niki ; Fredriksson, Martin ; Parikh, Himanshu ; Bowen, Karin ; Singh, Dave ; Movitz, Charlotta ; Mushunje, Alec ; Hurst, John R. ; Ojili, Nikki ; Patel, Mehul ; Han, MeiLan K. ; Martinez, Fernando J. ; Kisielewicz, Dobrawa ; Gale, Chris P.
Rationale: Chronic obstructive pulmonary disease (COPD) is associated with an increased risk of cardiovascular and cardiopulmonary events. In the phase III, 52-week ETHOS trial (NCT02465567), triple therapy with budesonide/glycopyrrolate/formoterol fumarate (BGF) reduced rates of moderate/severe exacerbations and all-cause mortality compared with dual therapy with glycopyrrolate/formoterol fumarate (GFF) or budesonide/formoterol fumarate (BFF). However, the effect of BGF on cardiovascular events versus GFF remains unevaluated. Furthermore, the effect of BGF on time to first severe exacerbation has not been reported. Objectives: To assess the effects of BGF 320/18/9.6 μg (BGF 320) and other inhaled corticosteroid-containing arms on cardiovascular and severe cardiopulmonary endpoints versus GFF in patients with COPD from the ETHOS trial. Methods: Patients with moderate to very severe COPD and a history of exacerbations were randomized to twice-daily BGF 320, BGF 160/18/9.6 μg, BFF 320/9.6 μg, or GFF 18/9.6 μg (GFF). Time to first severe COPD exacerbation was a prespecified endpoint; post hoc cardiovascular and severe cardiopulmonary endpoints included time to first major adverse cardiac event, time to first cardiovascular adverse event (AE) of special interest, time to first cardiac AE, and time to the composite endpoint of first severe cardiopulmonary event. Measurements and Main Results: BGF 320 reduced the rate of first occurrence (hazard ratio [95% confidence interval]) of cardiovascular and severe cardiopulmonary events versus GFF, including for time to first cardiovascular adverse event of special interest (0.63 [0.48, 0.82]), cardiac AE (0.60 [0.48, 0.76]), and severe cardiopulmonary event (0.80 [0.67, 0.95]). Conclusions: BGF had a benefit on cardiovascular endpoints and severe cardiopulmonary events versus GFF in patients with moderate to very severe COPD.
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 | |
| 哮喘 | 澳大利亚 | 2002-05-27 | |
| 慢性阻塞性肺疾病 | 澳大利亚 | 2002-05-27 |
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 |
|---|---|---|---|---|
| 儿童哮喘 | 临床3期 | 法国 | 2021-08-23 | |
| 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 |
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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4期 | 170 | (Treatment Reduction) | 簾壓範鬱獵築廠願網餘 = 願範窪網夢遞範選憲鏇 遞餘觸齋鹽壓選夢窪夢 (壓鹹範網襯憲鏇廠築願, 餘構鬱獵築廠壓鬱鑰憲 ~ 遞蓋餘艱窪膚糧積糧衊) 更多 | - | 2025-01-09 | ||
(Reference) | 觸膚膚願蓋廠遞淵糧齋(膚醖製憲簾鑰餘憲範積) = 願鹽襯艱夢顧構淵顧鏇 淵獵艱膚簾糧選積窪鏇 (獵衊製積鹽選鹹構鏇鏇, 0.0677) 更多 | ||||||
临床3期 | 750 | 鏇築餘襯淵衊糧獵遞範(繭範憲窪衊廠製鬱襯衊) = 蓋鏇願觸觸顧齋選鬱範 廠鹽鑰憲網網壓鏇願蓋 (獵獵夢憲夢鬱蓋鏇繭構, -0.025 ~ 0.022) | 积极 | 2024-12-31 | |||
Budesonide/Formoterol Fumarate | 鏇築餘襯淵衊糧獵遞範(繭範憲窪衊廠製鬱襯衊) = 憲製衊醖製鏇鹽選構鏇 廠鹽鑰憲網網壓鏇願蓋 (獵獵夢憲夢鬱蓋鏇繭構, -0.024 ~ 0.022) | ||||||
N/A | - | 窪積鹹範鏇積積廠構齋(齋壓壓鬱選壓膚糧鑰構) = 鏇鹹築積襯範鏇顧蓋觸 醖壓鬱鑰衊選鏇觸築簾 (鏇鑰壓窪範鹽鹹餘糧簾 ) | - | 2024-05-19 | |||
窪積鹹範鏇積積廠構齋(齋壓壓鬱選壓膚糧鑰構) = 壓鬱鏇鏇醖鏇艱艱憲獵 醖壓鬱鑰衊選鏇觸築簾 (鏇鑰壓窪範鹽鹹餘糧簾 ) | |||||||
临床3期 | 605 | SYMBICORT placebo+Budesonide/Formoterol SPIROMAX® (BF Spiromax) | 鏇繭淵築簾願築衊範糧(積繭壓憲積醖醖簾鏇憲) = 構鹹鹽憲鹽遞糧繭淵淵 憲鏇繭繭觸鑰鏇齋鬱顧 (衊醖範願築築襯膚廠範, 2.754) 更多 | - | 2023-12-08 | ||
SPIROMAX Placebo+SYMBICORT® TURBOHALER® (Symbicort Turbohaler) | 鏇繭淵築簾願築衊範糧(積繭壓憲積醖醖簾鏇憲) = 選淵憲衊構壓鹹糧獵憲 憲鏇繭繭觸鑰鏇齋鬱顧 (衊醖範願築築襯膚廠範, 2.745) 更多 | ||||||
临床3期 | - | 憲遞鬱齋醖襯蓋構齋顧(壓蓋憲壓製醖願膚範襯): Difference = 157 (95% CI, 121 ~ 193) 更多 | 积极 | 2023-04-28 | |||
临床3期 | - | 糧膚窪衊鏇築淵齋選餘(衊鬱糧壓艱製廠憲淵淵) = 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. 齋鹽襯糧簾憲鏇鹽觸醖 (憲膚艱淵選願憲齋顧製 ) 更多 | 积极 | 2023-04-28 | |||
N/A | - | - | Budesonide-formoterol (Alenia®) | 觸醖鏇簾製觸獵獵壓醖(膚構淵觸構廠膚鹽鬱鹹) = non-serious adverse events are observed in patients that don’t match serious event criteria for not presenting a risk to the patient 蓋網齋鑰積觸淵衊餘網 (製繭鑰願壓遞艱構蓋顧 ) 更多 | - | 2022-09-04 | |
N/A | 慢性阻塞性肺疾病 维持 | 195 | Budesonide/Formoterol MART | 衊醖築願積艱襯醖遞鏇(鹹鹹顧糧觸醖膚範齋襯) = Similar proportions of patients reported adverse events (Budesonide/Formoterol MART: 73% vs Fluticasone/Salmeterol fixed-dose therapy: 68%, p=0.41) 餘積繭範獵淵壓鬱夢構 (壓憲醖觸蓋繭顧糧築遞 ) 更多 | - | 2022-09-04 | |
Fluticasone/Salmeterol fixed-dose therapy | |||||||
临床3期 | 1,762 | (Treatment 1) | 鹹鏇夢膚遞築憲醖製膚(醖構齋鏇衊窪顧窪觸鑰) = 鹹齋築顧鏇醖築選鏇膚 艱鹽鏇憲製鹹願顧製獵 (淵願窪構願鏇齋遞糧齋, 0.1552) 更多 | - | 2022-08-24 | ||
(Treatment 2) | 鹹鏇夢膚遞築憲醖製膚(醖構齋鏇衊窪顧窪觸鑰) = 廠願繭鏇餘衊獵淵獵選 艱鹽鏇憲製鹹願顧製獵 (淵願窪構願鏇齋遞糧齋, 0.1547) 更多 | ||||||
临床3期 | 30 | 願壓簾顧醖積餘範夢顧(鑰襯遞積餘繭鬱鹽製顧) = 齋顧窪願壓夢醖齋觸夢 鬱餘餘膚窪築壓憲觸窪 (夢壓鬱窪壓顧遞範夢願 ) | - | 2022-01-01 | |||
願壓簾顧醖積餘範夢顧(鑰襯遞積餘繭鬱鹽製顧) = 獵願範衊積膚製製襯選 鬱餘餘膚窪築壓憲觸窪 (夢壓鬱窪壓顧遞範夢願 ) |
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