Target- |
MechanismCell membrane permeability enhancers [+1] |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.Switzerland |
First Approval Date07 Jul 1993 |
/ RecruitingNot Applicable Impact of Fixed TRIple Therapy With Beclometasone/Formoterol/Glycopyrronium DPI (Trimbow® in NEXThaler Device) in Chronic Obstructive PulmoNary Disease in rEal-world Settings: Health-related Quality of Life Patient' eXpectations and characterisTics: the TriNEXT Study
This is an observational, prospective, multicentric, cohort study conducted in France to evaluate the QoL in COPD patients treated with TRIMBOW NEXThaler 88/5/9 in a routine clinical practice setting. Patients enrolled in this study will be patients diagnosed with a COPD with a ratio of post-bronchodilator (salbutamol 400 μg) forced expiratory volume in 1 s (FEV1) to forced vital capacity (FVC) of less than 0.7 to whom TRIMBOW NEXThaler 88/5/9 has been initiated by an hospital or local pulmonologists in accordance with clinical practice and marketing authorization.
/ RecruitingNot Applicable A Multicentre, Prospective, Non-interventional Trial Monitoring Therapy Pathways of Asthma Patients Treated With an Extra-fine ICS/LABA/LAMA Single-inhaler Triple Therapy in a Real-world Setting and Characterizing the Effects on Health-related Outcomes
TriMaximize, a non-interventional trial aims to collect prospective, longitudinal data from asthma patients under routine care, for whom their treating physician has decided to prescribe Trimbow® (beclometasone/formoterol/glycopyrronium).
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 dipropionate/formoterol 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] Primary objective: To demonstrate the non-inferiority of CHF1535pMDI to Symbicort in lung function (change from baseline in forced expiratory volume in one second (FEV1) before morning dosing at week 24) in patients with COPD. Secondary objectives: To assess the effect of CHF1535pMDI on other lung function parameters and patient-reported outcomes (PROs). To assess the safety and tolerability of the study treatment.
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