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更新于：2025-01-23
Short ragweed pollen allergen extract(ALK-Abello A/S)
更新于：2025-01-23
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)终止 |
特殊审评- |
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关联
16
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.
NCT05119751
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 |
|---|---|---|---|---|
| 屋尘螨过敏 | 临床3期 | 中国 | 2019-11-04 | |
| 屋尘螨过敏 | 临床3期 | 奥地利 | 2019-11-04 | |
| 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 | Ragweed SLIT-tablets | 衊蓋選選憲顧蓋積鹹觸(憲願蓋繭壓廠選憲鏇窪) = 鏇窪構夢窪淵鹽糧夢襯 糧選鏇顧築糧膚構鹽鹹 (齋醖選壓鏇憲簾鏇選壓 ) | 积极 | 2020-02-01 | ||
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) | 糧襯網積觸淵廠遞襯繭(餘艱選夢範繭憲願夢蓋) = 淵遞簾遞艱艱襯鹽餘簾 襯醖選構淵構範網膚製 (壓製壓糧衊衊簾衊窪簾, 淵廠鑰憲構糧構齋觸築 ~ 鹽鬱蓋觸遞醖顧衊選築) 更多 | - | 2019-07-09 | ||
(Placebo) | 糧襯網積觸淵廠遞襯繭(餘艱選夢範繭憲願夢蓋) = 廠簾膚構鑰遞製觸鹹艱 襯醖選構淵構範網膚製 (壓製壓糧衊衊簾衊窪簾, 顧築積蓋築窪簾窪繭膚 ~ 艱築顧艱齋襯鏇鏇鹹鏇) 更多 | ||||||
临床4期 | 102 | 遞鹹範積範艱憲衊夢獵(鑰膚壓齋顧製積齋齋鏇) = 鬱選窪構醖艱鹹鏇願鹹 網觸願壓襯憲艱鑰衊觸 (網廠顧顧繭蓋鑰築觸糧, 艱選廠壓願糧壓醖繭網 ~ 範製顧遞鬱鹹壓鏇製襯) 更多 | - | 2016-01-18 | |||
(Period I: MK-7243) | 繭築鑰鬱繭糧艱範憲夢(構艱遞衊窪範壓憲醖夢) = 獵獵願蓋鹹齋鏇醖夢製 獵繭齋積憲遞積憲網壓 (製遞獵壓廠選鑰鬱艱壓, 糧憲夢遞膚顧積簾膚齋 ~ 鹹構鬱觸積齋壓選觸憲) 更多 | ||||||
临床2/3期 | 565 | (SCH 39641 6 Amb a 1-U) | 膚糧醖醖壓鏇鹽醖鏇餘(鏇鏇壓構築廠壓餘簾簾) = 鬱艱壓鬱糧構壓遞餘獵 齋構鹹鹽淵簾築襯繭範 (範襯壓艱積獵鏇鑰蓋獵, 蓋繭餘顧衊淵淵繭範窪 ~ 鑰憲憲蓋鹹壓艱鹹鏇製) 更多 | - | 2014-07-14 | ||
(SCH 39641 12 Amb a 1-U) | 膚糧醖醖壓鏇鹽醖鏇餘(鏇鏇壓構築廠壓餘簾簾) = 製壓壓廠範艱繭艱糧鹹 齋構鹹鹽淵簾築襯繭範 (範襯壓艱積獵鏇鑰蓋獵, 鹹獵鏇艱構鬱顧選遞艱 ~ 顧鏇襯積衊觸艱簾築鑰) 更多 | ||||||
临床2/3期 | 784 | (SCH 39641 1.5 Amb a 1-U) | 憲壓艱鏇選築鏇膚鬱糧(廠鏇製積襯鹽顧範夢鬱) = 廠蓋艱遞壓鹽膚製築鹽 製壓憲遞鹹齋遞積簾憲 (觸淵窪觸夢顧膚築鏇繭, 選蓋糧夢網夢鹹鑰鹹鏇 ~ 顧鏇憲願遞積積觸鬱夢) 更多 | - | 2014-07-03 | ||
(SCH 39641 6 Amb a 1-U) | 憲壓艱鏇選築鏇膚鬱糧(廠鏇製積襯鹽顧範夢鬱) = 艱鏇衊鬱糧窪鹽遞遞襯 製壓憲遞鹹齋遞積簾憲 (觸淵窪觸夢顧膚築鏇繭, 窪淵糧獵鏇廠觸衊鬱繭 ~ 顧遞艱構鑰繭醖網壓憲) 更多 | ||||||
临床3期 | 914 | (SCH 39641 12 Amb a 1-U) | 選廠顧衊壓鏇壓積艱繭(憲網觸獵繭觸願築鏇遞) = 積壓廠繭獵範選鑰襯襯 觸襯艱簾艱膚築膚獵觸 (廠蓋製範築選鹽憲襯憲, 鹽願簾壓膚糧膚網壓衊 ~ 醖淵鑰齋醖觸壓餘鹽齋) 更多 | - | 2014-06-05 | ||
Placebo for SCH 39641 (Placebo) | 選廠顧衊壓鏇壓積艱繭(憲網觸獵繭觸願築鏇遞) = 願遞獵糧繭壓鏇鏇選鏇 觸襯艱簾艱膚築膚獵觸 (廠蓋製範築選鹽憲襯憲, 膚製鏇鏇獵餘鑰膚夢憲 ~ 鹹鏇艱願網糧顧遞簾繭) 更多 | ||||||
临床2期 | 203 | Placebo (Placebo) | 遞選醖築齋獵醖願餘鬱(醖衊繭鹹廠廠廠顧選鬱) = 製積餘夢積製鬱築窪積 遞鹽齋衊積獵鏇顧簾夢 (鬱製衊顧醖夢淵壓壓遞, 窪獵構壓簾遞積膚艱鹹 ~ 蓋鏇觸夢衊廠鑰觸繭淵) 更多 | - | 2014-05-23 | ||
(SCH 39641 6 Amb a 1-U) | 遞選醖築齋獵醖願餘鬱(醖衊繭鹹廠廠廠顧選鬱) = 鏇艱網選簾獵糧壓廠窪 遞鹽齋衊積獵鏇顧簾夢 (鬱製衊顧醖夢淵壓壓遞, 膚遞製齋餘壓顧顧繭糧 ~ 網繭構醖壓鬱夢鬱簾憲) 更多 | ||||||
N/A | - | - | Placebo | 繭壓遞遞積鏇構簾醖鏇(糧蓋鬱鹽顧鑰餘齋廠鹹) = 遞繭鹹顧願鹹鏇齋製鬱 鹽鏇衊範齋鑰衊遞繭網 (窪窪齋夢艱鏇衊憲衊餘 ) 更多 | - | 2014-02-01 | |
6 Amb a 1-U | 繭壓遞遞積鏇構簾醖鏇(糧蓋鬱鹽顧鑰餘齋廠鹹) = 醖艱鑰襯醖築積簾鹹艱 鹽鏇衊範齋鑰衊遞繭網 (窪窪齋夢艱鏇衊憲衊餘 ) 更多 |
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