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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.CN |
First Approval Date01 Jan 2013 |
比较丙酸倍氯米松/富马酸福莫特与布地奈德/富马酸福莫特罗治疗COPD的24周临床试验
[Translation] A 24-week clinical trial comparing beclomethasone propionate/formote fumarate with budesonide/formoterol fumarate in the treatment of COPD
主要目的:证明CHF1535pMDI治疗COPD患者在肺功能方面(第24周的早晨用药前一秒用力呼气量(FEV1)较基线变化)非劣效于信必可都保。 次要目的:评估CHF1535pMDI对其它肺功能参数和患者报告的结局(PRO)的影响。评估研究治疗的安全性和耐受性。
[Translation] Main objective: To demonstrate that CHF1535pMDI is non-inferior to Symbicort in lung function (change from baseline in forced expiratory volume in one second (FEV1) in the morning at week 24) in COPD patients. Secondary objective: To assess the effect of CHF1535pMDI on other pulmonary function parameters and patient-reported outcomes (PROs). Assess the safety and tolerability of the study treatment.
在健康中国受试者中评估 CHF 5993 吸入气雾剂100/6/12.5 μg 固定组方的药代动力学研究
[Translation] Pharmacokinetic study evaluating CHF 5993 inhalation aerosol 100/6/12.5 μg fixed formulation in healthy Chinese subjects
主要目标:在健康中国受试者中评价治疗剂量下单次和重复给予 CHF5993 pMDI 后和超治疗剂量下单次给予 CHF5993 pMDI 后,二丙酸倍氯米松 (BDP)、17 单丙酸倍氯米松 (B17MP)、福莫特罗和溴化吡铂 (GB) 的药代动力学。 次要目标:评估治疗剂量下第 1 天和第 7 天、以及超治疗剂量下第 1 天早晨给予 CHF 5993 pMDI 后 12 小时内的全身效应(收缩压 [SBP]、舒张压 [DBP]、心率 [HR]、QTcF)。评估研究治疗的安全性和耐受性。
[Translation] MAIN OBJECTIVE: To evaluate the effects of beclomethasone dipropionate (BDP), 17 beclomethasone dipropionate (BDP), beclomethasone dipropionate (BDP), 17 Pharmacokinetics of metasone (B17MP), formoterol and picoplatin bromide (GB). Secondary objective: To assess systemic effects (systolic blood pressure [SBP], diastolic blood pressure [DBP], heart rate, systolic blood pressure [SBP], diastolic blood pressure [DBP], heart rate] within 12 hours of CHF 5993 pMDI in the morning at therapeutic doses on Days 1 and 7, and on Day 1 at supratherapeutic doses. [HR], QTcF). Assess the safety and tolerability of the study treatment.
一项24周国际多中心临床研究,在COPD患者中比较CHF 5993与布地奈德福莫特罗粉吸入剂的有效性和安全性
[Translation] A 24-week international multicenter clinical study comparing the efficacy and safety of CHF 5993 and budesonide formoterol powder inhaler in patients with COPD
主要目的:证明在肺功能方面(在第24周给药前早上FEV1和给药后2小时早上FEV1相对于基线的变化),优于信必可都保 关键次要目的:证明在中国亚组人群中,在肺功能方面(在第24周给药前早上FEV1和给药后2小时早上FEV1相对于基线的变化),优于信必可都保。 其他次要目的:评价对其他肺部功能参数、患者健康状况和临床结果测量的作用;评价研究药物的安全性和耐受性等。
[Translation] Primary objective: To demonstrate superiority to Symbicort in terms of lung function (change from baseline in FEV1 in the morning before dosing at Week 24 and 2 hours post-dose in morning FEV1) In the population, lung function (change from baseline in FEV1 in the morning before dosing at Week 24 and 2 hours after dosing from baseline) was superior to Symbicort. Other secondary objectives: to evaluate effects on other pulmonary function parameters, patient health status and clinical outcome measures; to evaluate the safety and tolerability of study drugs, etc.
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