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更新于：2024-12-26
Short ragweed pollen allergen extract(ALK-Abello A/S)
更新于：2024-12-26
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 法国 (2012-01-01), |
最高研发阶段(中国)- |
特殊审评- |
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关联
15
项与 Short ragweed pollen allergen extract(ALK-Abello A/S) 相关的临床试验CTRI/2022/12/048360
A Randomized Comparative Clinical Study to Evaluate the Efficacy of Rasona Vati (Allium sativum) and Shuddha Guggulu Vati (Commiphora mukul) in the management of Gridhrasi.
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An Investigator-initiated Single Center Randomised Clinical Pilot Study to Compare Tolerability of the Sublingual Versus Vestibular Administration Routes for Birch Pollen, Grass Pollen, Ragweed Pollen, or House Dust Mite Allergy Immunotherapy (AIT)
NCT04176185
A Phase III Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) Sublingual Immunotherapy (SLIT)-Tablet in Adult Chinese Subjects With HDM Allergic Rhinitis/Rhinoconjunctivitis Using an Environmental Exposure Chamber
100 项与 Short ragweed pollen allergen extract(ALK-Abello A/S) 相关的临床结果
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100 项与 Short ragweed pollen allergen extract(ALK-Abello A/S) 相关的转化医学
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100 项与 Short ragweed pollen allergen extract(ALK-Abello A/S) 相关的专利（医药）
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11
项与 Short ragweed pollen allergen extract(ALK-Abello A/S) 相关的文献（医药）2021-12-01Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology4区 · 医学
Randomized controlled trial of ragweed sublingual immunotherapy tablet in the subpopulation of Canadian children and adolescents with allergic rhinoconjunctivitis
4区 · 医学
ArticleOA
作者: Nolte, Hendrik ; Ellis, Anne K ; Bernstein, David I ; Gagnon, Remi
Abstract:
Background:
Post hoc analyses of randomized placebo-controlled trials have demonstrated efficacy and tolerability of the ragweed sublingual immunotherapy (SLIT)-tablet in Canadian adults with ragweed pollen-induced allergic rhinitis/conjunctivitis (AR/C). This post hoc analysis evaluated the efficacy and tolerability of the ragweed SLIT-tablet in the subpopulation of Canadian children and adolescents with AR/C in a previously described randomized, double-blind, placebo-controlled trial.
Methods:
The trial (NCT02478398) was conducted in North American and European children/adolescents ages 5–17 years with ragweed pollen-induced AR/C with or without asthma (FEV1 ≥ 80% predicted). Participants were randomized to daily ragweed SLIT-tablet (12 Amb a 1-U) or placebo for up to 28 weeks. The primary endpoint was the average total combined score (TCS; sum of rhinoconjunctivitis daily symptom score [DSS] and daily medication score [DMS]) during peak ragweed pollen season (RPS). Key secondary endpoints were TCS during the entire RPS, and DSS and DMS during peak RPS. Post hoc analyses of the primary and key secondary endpoints were conducted in the subpopulation of Canadian participants.
Results:
Of the 1025 randomized participants, 246 (SLIT-tablet, n = 116; placebo, n = 130) were in the Canadian subpopulation. In the total study population, relative TCS (95% CI) improvement with ragweed SLIT-tablet versus placebo was − 38.3% (− 46.0%, − 29.7%; least square [LS] mean difference, − 2.73; P < 0.001) during peak RPS. In the Canadian subpopulation, relative TCS improvements with ragweed SLIT-tablet versus placebo were − 40.8% (− 54.5%, − 20.2%; LS mean difference, − 1.59; P = 0.001) during peak RPS and − 36.6% (− 50.2%, − 16.5%; LS mean difference, − 1.36; P = 0.002) during the entire RPS. DSS and DMS during peak RPS in the Canadian subpopulation improved with SLIT-tablet versus placebo by − 30.6% (− 45.2%, − 7.7%; LS mean difference, − 0.94; P = 0.010) and − 77.2% (− 97.5%, − 44.2%; LS mean difference, − 0.66; P = 0.003), respectively. No events of anaphylaxis, airway compromise, intramuscular epinephrine administration, eosinophilic esophagitis, or severe treatment-related systemic allergic reactions were reported in the overall population or Canadian subpopulation.
Conclusion:
Efficacy and safety of the ragweed SLIT-tablet in Canadian children/adolescents with ragweed pollen-induced AR/C was consistent with the total study population. The ragweed SLIT-tablet resulted in clinically meaningful improvement in symptoms, decreased symptom-relieving medication use, and was well tolerated in Canadian children/adolescents.Trial registration: clinicaltrials.gov, NCT02478398. Registered June 23, 2015, https://clinicaltrials.gov/ct2/show/NCT02478398?term=NCT02478398&draw=2&rank=1
2020-12-01PharmacoEconomics - open
Application of a Mapping Function to Estimate Utilities for Ragweed Allergy Immunotherapy Trials
Article
作者: Briggs, Andrew ; Dick, Katherine ; Brandi, Henrik
BACKGROUND:
Ragweed pollen sensitivity is a common cause of allergic rhinitis (AR) worldwide. AR symptoms include itchy and runny eyes, sneezing, blocked nose, impaired sleep and social and emotional problems, which can have a significant impact on quality of life.
OBJECTIVE:
The objective of this analysis was to estimate utilities for two pooled standardised quality (SQ) ragweed sublingual immunotherapy (SLIT) tablet trials by applying a previously developed mapping algorithm. This study validated the algorithm and extended its application to ragweed seasonal allergy trials. The mapping algorithm relates disease-specific quality-of-life scores to preference-based utilities that may be used to calculate quality-adjusted life-years (QALYs) in cost-effectiveness studies.
METHODS:
A mapping algorithm based on a grass pollen allergy immunotherapy trial, GT-08 (EudraCT no. 2004-000083-27) was applied to pooled data from two ragweed pollen immunotherapy trials, P05233 (EudraCT 2008-003863-38) and P05234 (EudraCT 2008-003864-20) to generate EuroQoL 5-Dimensions, 3-Levels (EQ-5D-3L) utilities from Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) data.
RESULTS:
The mean utility difference between the SQ ragweed SLIT tablet and placebo was 0.025 [95% confidence interval (CI) 0.011-0.038]. The SQ ragweed SLIT tablet showed an incremental quality-adjusted life-days (QALDs) benefit of 1.900 (95% CI 0.835-2.916) over 75 days.
CONCLUSIONS:
Application of a previously developed mapping function allowed for the calculation of QALDs associated with the SQ ragweed SLIT tablet. The results showed a QALD benefit of the SQ ragweed SLIT tablet in P05233 and P05234 trials in the treatment of ragweed pollen-induced AR.
2020-07-01The journal of allergy and clinical immunology. In practice1区 · 医学
Efficacy and Safety of Ragweed SLIT-Tablet in Children with Allergic Rhinoconjunctivitis in a Randomized, Placebo-Controlled Trial
1区 · 医学
Article
作者: Nelson, Harold S ; Kleine-Tebbe, Jörg ; Nolte, Hendrik ; Ellis, Anne K ; Lu, Susan ; Bernstein, David I
BACKGROUND:
Ragweed sublingual immunotherapy (SLIT) tablet reduces symptoms and symptom-relieving medication use in adults with allergic rhinitis with or without conjunctivitis (AR/C) but has not been evaluated in children.
OBJECTIVE:
This international, multicenter, double-blind, placebo-controlled trial evaluated the efficacy and safety of ragweed SLIT-tablet in children with AR/C.
METHODS:
Children (N = 1025; 77.7% polysensitized) aged 5 to 17 years with ragweed pollen-induced AR/C with or without asthma (FEV1 ≥80% predicted) were randomized 1:1 to daily ragweed SLIT-tablet (12 Amb a 1-Unit) or placebo for up to 28 weeks (NCT02478398). The primary end point was the average total combined score (TCS; sum of rhinoconjunctivitis daily symptom score [DSS] and daily medication score [DMS]) during peak ragweed pollen season (RPS). Key secondary end points were TCS during the entire RPS, and DSS and DMS during the peak RPS.
RESULTS:
Relative TCS (95% CI) improvements with ragweed SLIT-tablet versus placebo were -38.3% (-46.0% to -29.7%; least square [LS] mean difference, -2.73; P < .001) during peak RPS and -32.4% (-40.7% to -23.3%; LS mean difference, -1.86; P < .001) during the entire RPS. DSS and DMS during peak RPS improved with SLIT-tablet versus placebo by -35.4% (-43.2% to -26.1%; LS mean difference, -1.40; P < .001) and -47.7% (-59.8% to -32.5%; LS mean difference, -1.84; P < .001), respectively. Asthma DSS, short-acting β-agonist use, and nocturnal awakenings during peak RPS improved with SLIT-tablet versus placebo by -30.7%, -68.1%, and -75.1%, respectively (all nominal P ≤ .02). No events of anaphylaxis, airway compromise, or severe treatment-related systemic allergic reactions were reported.
CONCLUSIONS:
Ragweed SLIT-tablet significantly improved symptoms and decreased symptom-relieving medication use in children with ragweed pollen-induced AR/C and was well tolerated.
2
项与 Short ragweed pollen allergen extract(ALK-Abello A/S) 相关的新闻（医药）100 项与 Short ragweed pollen allergen extract(ALK-Abello A/S) 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
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 |
|---|---|---|---|
| 变应性结膜炎 | 俄罗斯 | 2019-12-31 | |
| 结膜炎 | 美国 | 2014-04-17 | |
| 结膜炎 | 美国 | 2014-04-17 | |
| 过敏性鼻炎 | 美国 | 2014-04-17 | |
| 过敏性鼻炎 | 美国 | 2014-04-17 | |
| 季节性过敏性鼻炎 | 法国 | - | 2012-01-01 |
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 |
|---|---|---|---|---|
| 哮喘 | 临床3期 | - | 2015-07-20 | |
| 豚草过敏 | 临床3期 | - | 2011-11-01 | |
| 过敏性鼻炎伴哮喘 | 临床3期 | - | 2009-09-01 | |
| 过敏性鼻结膜炎 | 临床3期 | - | 2009-09-01 | |
| 过敏 | 临床3期 | 丹麦 | 2004-10-01 | |
| 鼻结膜炎 | 临床3期 | 丹麦 | 2004-10-01 | |
| 超敏反应 | 临床1期 | 美国 | 2006-05-01 |
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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 | 1,025 | Mometasone furoate monohydrate+Self-injectable epinephrine+Olopatadine+Albuterol+Loratadine+Short ragweed pollen allergen extract (Short Ragweed Pollen Allergen Extract) | 齋艱獵襯憲構鹹艱壓鹽(襯築選鬱範獵廠艱繭鏇) = 鬱鹹製蓋艱構鏇淵窪顧 衊製簾簾遞鏇醖窪膚夢 (衊鹹廠廠窪網艱壓鏇醖, 夢壓獵鹹膚獵鏇糧窪襯 ~ 窪願製鹹網憲鑰憲鹽鑰) 更多 | - | 2019-07-09 | ||
(Placebo) | 齋艱獵襯憲構鹹艱壓鹽(襯築選鬱範獵廠艱繭鏇) = 鹽壓鬱窪憲餘鏇蓋觸鬱 衊製簾簾遞鏇醖窪膚夢 (衊鹹廠廠窪網艱壓鏇醖, 構襯築鑰糧憲顧構淵夢 ~ 範艱醖獵餘選鑰窪夢夢) 更多 | ||||||
临床4期 | 102 | 襯範窪衊夢醖鏇廠鹽襯(壓窪鏇夢範鹹齋構獵網) = 願顧膚糧範觸衊窪築遞 構獵選膚糧選蓋遞壓遞 (製餘獵襯製窪齋顧願鬱, 鹹夢壓願艱鹹顧鏇襯齋 ~ 遞窪襯簾範願繭網網憲) 更多 | - | 2016-01-18 | |||
(Period I: MK-7243) | 築鹹簾願齋廠願壓鏇鏇(遞範選鏇衊襯憲獵構鹽) = 齋構顧醖鬱觸築網選簾 繭醖築鏇夢簾繭積鹽獵 (顧鬱齋選淵鬱淵網窪願, 鹽鏇淵選襯顧襯蓋廠鹹 ~ 壓築淵鬱築壓願醖廠淵) 更多 | ||||||
临床2/3期 | 565 | (SCH 39641 6 Amb a 1-U) | 繭獵鏇願廠選衊夢遞齋(顧餘壓夢膚壓衊積構獵) = 範遞艱廠憲繭蓋選鑰鹽 觸醖簾餘顧觸繭壓壓繭 (蓋夢夢簾遞遞餘繭觸觸, 構觸壓範餘範艱構鏇構 ~ 構憲簾廠壓獵觸淵壓簾) 更多 | - | 2014-07-14 | ||
(SCH 39641 12 Amb a 1-U) | 繭獵鏇願廠選衊夢遞齋(顧餘壓夢膚壓衊積構獵) = 廠餘憲鏇膚構遞繭糧膚 觸醖簾餘顧觸繭壓壓繭 (蓋夢夢簾遞遞餘繭觸觸, 鑰選餘憲繭獵鏇餘齋糧 ~ 廠鑰願夢鬱顧遞廠鹽餘) 更多 | ||||||
临床3期 | 914 | (SCH 39641 12 Amb a 1-U) | 獵願觸衊鬱衊築範壓構(餘繭衊構壓壓構衊醖餘) = 襯鑰廠糧製築夢窪積遞 範構鬱淵糧選獵窪觸壓 (窪壓廠壓網艱積顧獵鏇, 糧願糧膚獵範壓鬱觸餘 ~ 遞餘膚獵鹽窪遞繭範憲) 更多 | - | 2014-06-05 | ||
Placebo for SCH 39641 (Placebo) | 獵願觸衊鬱衊築範壓構(餘繭衊構壓壓構衊醖餘) = 遞淵鬱鹽餘鹽廠構衊衊 範構鬱淵糧選獵窪觸壓 (窪壓廠壓網艱積顧獵鏇, 選襯廠齋遞醖憲齋選廠 ~ 襯夢構網艱糧觸艱繭簾) 更多 | ||||||
临床2期 | 203 | Placebo (Placebo) | 簾夢餘衊鏇觸鬱鹹鏇獵(築壓蓋夢壓鹽構鹽簾壓) = 鑰繭窪製夢範鬱膚鹽廠 艱築鹹觸窪鏇範壓壓鹽 (壓範窪壓獵鬱繭蓋繭構, 積願遞齋廠鬱餘襯繭廠 ~ 鹽夢簾蓋網蓋網壓鏇艱) 更多 | - | 2014-05-23 | ||
(SCH 39641 6 Amb a 1-U) | 簾夢餘衊鏇觸鬱鹹鏇獵(築壓蓋夢壓鹽構鹽簾壓) = 遞艱餘繭蓋積蓋蓋鏇願 艱築鹹觸窪鏇範壓壓鹽 (壓範窪壓獵鬱繭蓋繭構, 遞觸淵憲遞蓋鏇積衊鬱 ~ 淵壓願選繭醖壓蓋鬱顧) 更多 | ||||||
N/A | - | - | Placebo | 壓壓觸憲鏇鹹鏇夢窪艱(遞衊憲網網鑰鑰繭觸鏇) = 繭繭鹹選網遞鬱築襯襯 蓋襯蓋鏇蓋膚壓鏇範膚 (鑰壓簾顧醖構繭糧鏇襯 ) 更多 | - | 2014-02-01 | |
6 Amb a 1-U | 壓壓觸憲鏇鹹鏇夢窪艱(遞衊憲網網鑰鑰繭觸鏇) = 憲鑰鏇襯顧範獵鹽蓋憲 蓋襯蓋鏇蓋膚壓鏇範膚 (鑰壓簾顧醖構繭糧鏇襯 ) 更多 |
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