A Randomised, Double-blind, Placebo-controlled 4-period Cross-over Study to Assess the Efficacy and Safety of Repeat Dose Intranasal GSK1004723 (1000µg), Oral GSK835726 (10mg) and Cetirizine (10mg) in the Environmental Challenge Chamber in Subjects With Seasonal Allergic Rhinitis

This is a randomised, double-blind, placebo-controlled 4-period cross-over study to assess the efficacy and safety of repeat dose intranasal GSK1004723 (1000µg), oral GSK835726 (10mg) and cetirizine (10mg) in the environmental challenge chamber in subjects with seasonal allergic rhinitis.

开始日期2009-06-01

申办/合作机构

GSK Plc

EUCTR2008-004092-22-DE / Not yet recruitingN/A

A randomised, double-blind, placebo-controlled, 4-period incomplete block crossover study of single oral dose GSK835726 (100mg, 50mg, 10mg), Cetirizine (10mg) and placebo to evaluate the efficacy and safety using an Environmental challenge chamber in male subjects with seasonal allergic rhinitis.

开始日期2008-09-03

申办/合作机构-

NCT00851344 / Completed临床2期

A Randomised, Double-blind, Placebo-controlled, 4-period Incomplete Block Crossover Study of Single Oral Dose GSK835726 (100mg, 50mg, 10mg), Cetirizine (10mg) and Placebo to Evaluate the Efficacy and Safety Using an Environmental Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis

开始日期2008-09-01

申办/合作机构

GSK Plc

100 项与 GSK-835726 相关的临床结果

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100 项与 GSK-835726 相关的转化医学

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100 项与 GSK-835726 相关的专利（医药）

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项与 GSK-835726 相关的文献（医药）

2012-01-01·International Archives of Allergy and Immunology

The Efficacy and Tolerability of Two Novel H1/H3 Receptor Antagonists in Seasonal Allergic Rhinitis

Review

作者: Watson, Joanna ; McQuade, Barbara ; Daley-Yates, Peter ; Ambery, Claire ; Oliver, Amanda ; Sweeney, Lisa

Background: A therapeutic role for histamine H3 receptor antagonism in allergic rhinitis has been proposed and may be complimentary to the well-known benefits of H1 receptor antagonism. Combined H1/H3 blockade has therefore been investigated as a novel therapeutic approach that may enhance symptom relief, particularly nasal blockage. Methods: Two novel H1/H3 dual receptor antagonists were investigated in phase I and II safety and efficacy studies. One molecule (GSK1004723) was designed for intranasal administration as a suspension or solution and the other molecule (GSK835726) for oral administration. In phase I and II studies, both molecules were compared with an active control and/or placebo in randomised studies. In phase II studies, efficacy was assessed in an environmental allergen challenge chamber (ECC). Subjects with seasonal allergic rhinitis were exposed to allergen to induce symptoms. Efficacy and safety was measured over 4, 7 and 20–24 h post-dose. The endpoints included total nasal symptom score and nasal blockage. Results: Intranasal suspension of GSK1004723 and oral GSK835726 were well tolerated. Single-dose intranasal suspensions of GSK1004723 (220, 1,100 µg) failed to demonstrate clinically significant attenuation of symptoms of allergic rhinitis induced in the ECC. Single (10, 50, 100 mg) and 3-day repeat (10 mg) dose oral GSK835726 demonstrated clinically significant attenuation of symptoms in the ECC comparable to cetirizine 10 mg. Three-day repeat dosing of the intranasal solution GSK1004723 1,000 µg also demonstrated a statistically significant attenuation of nasal symptoms, but was less than seen with cetirizine and GSK835726 and caused initial nasal discomfort. Conclusions: Combined H1/H3 antagonism did not show differentiation from H1 antagonism in reducing total nasal symptom score or nasal blockage.

100 项与 GSK-835726 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
季节性过敏性鼻炎	临床2期	德国	GSK Plc	2008-09-01
过敏性鼻炎	临床2期	德国	GSK Plc	-

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临床结果

适应症

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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


NCT00972504 (CTgov)	临床2期	季节性过敏性鼻炎	54	placebo	餘廠鬱醖餘鏇構選糧願(憲淵製構憲觸構壓膚憲) = 膚築糧簾顧積願顧鏇獵構顧遞壓鹽構鑰鑰蓋艱 (獵膚築範醖鹹鬱觸鏇鬱, 願願淵網艱艱蓋製齋築 ~ 獵膚鏇繭膚窪網鹽醖觸) 更多	-	2017-08-02