Search results for "endpoint"
showing 10 items of 437 documents
Phase II study of pemetrexed and cisplatin plus cetuximab followed by pemetrexed and cetuximab maintenance therapy in patients with advanced nonsquam…
2013
Abstract Objectives The aim was to determine if combined pemetrexed, cisplatin, and cetuximab was efficacious and safe as first-line treatment in advanced nonsquamous non-small cell lung cancer (NSCLC). Patients and methods In this single-arm, multicenter clinical trial, patients with Stage IIIB/IV nonsquamous NSCLC received first-line therapy consisting of pemetrexed (500mg/m 2 ) and cisplatin (75mg/m 2 ) on Day 1 (21-day cycles) plus weekly cetuximab (400mg/m 2 loading dose, then 250mg/m 2 ) for 4–6 cycles. Non-progressing patients received maintenance therapy consisting of pemetrexed and cetuximab as above until disease progression. All patients received vitamin supplementation, dexameth…
P191 QVA149 once daily improves exercise tolerance and lung function in patients with moderate to severe COPD: the BRIGHT study: Abstract P191 Table 1
2012
Introduction QVA149 is a novel once-daily fixed-dose combination of the long-acting β 2 -agonist indacaterol and the long-acting muscarinic antagonist glycopyrronium (NVA237) in development for the treatment of chronic obstructive pulmonary disease (COPD). The BRIGHT study evaluated the effects of QVA149 versus placebo and tiotropium on exercise tolerance and lung function in patients with moderate-to-severe COPD. Methods In a double-blind, double-dummy, 3-period crossover study, patients with moderate-to-severe COPD were randomised to QVA149 110/50 µg, placebo or tiotropium 18 µg once daily for 3 weeks. The primary endpoint was exercise endurance time for QVA149 versus placebo during a sub…
Effects of inhaled corticosteroids in stable chronic obstructive pulmonary disease.
2011
Chronic obstructive pulmonary disease (COPD) has been described as a heterogeneous multifactorial disorder associated with an abnormal inflammatory response of the peripheral airways and with variable morphologic, physiologic and clinical phenotypes. This notion of the disease is actually poorly supported by data, and there are substantial discrepancies and a weak correlation between inflammation, structural damage, functional impairment and degree of clinical symptoms. This problem is compounded by a poor understanding of the complexity and intricacies on the inflammatory pathways in COPD. Despite the evidence for efficacy of inhaled corticosteroids (ICS) on selected clinical endpoints in …
Add-on salmeterol compared to double dose fluticasone in pediatric asthma: A double-blind, randomized trial (VIAPAED)
2009
Rationale In asthmatic children whose symptoms are uncontrolled on standard doses of inhaled corticosteroids (ICS), guidelines recommend to either increase the ICS dose or to add further controller medication, e.g. a long acting s2-agonist (LABA). The aim of this study was to compare the efficacy and safety of doubling the dose of ICS (fluticasone proprionate FP 200 µg twice daily) with adding a long-acting beta-2 agonist to the ICS (SFC, salmeterol 50 µg/ FP 100 µg twice daily) in children with uncontrolled asthma. Methods Children between 4 and 16 years of age were eligible for this multicenter, randomized, double blind, double dummy, parallel-group study. During a 14-day run-in phase, al…
Onset of Effect, Changes in Airflow Obstruction and Lung Volume, and Health-Related Quality of Life Improvements with Benralizumab for Patients with …
2020
Reynold A Panettieri Jr,1 Tobias Welte,2 Kartik V Shenoy,3 Stephanie Korn,4 Margret Jandl,5 Edward M Kerwin,6 Rosa Feijoo,7 Peter Barker,8 Richard F Olsson,9 Ubaldo J Martin8 On behalf of the SOLANA Study Investigators1Pulmonary, Allergy and Critical Care Division, University of Pennsylvania, Philadelphia, PA, USA; 2Department of Respiratory Medicine, Member of the German Center of Lung Research, Medizinische Hochschule Hannover, Hannover, Germany; 3Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA; 4Pulmonary Department, Universitätsmedizin Mainz, Langenbeckstr, Mainz, Germany; 5Hamburger Institut Für Th…
Strict blood-pressure control and progression of renal failure in children
2009
PubMedID: 19846849 BACKGROUND: Although inhibition of the renin-angiotensin system delays the progression of renal failure in adults with chronic kidney disease, the blood-pressure target for optimal renal protection is controversial. We assessed the long-term renoprotective effect of intensified blood-pressure control among children who were receiving a fixed high dose of an angiotensin-converting- enzyme (ACE) inhibitor. METHODS: After a 6-month run-in period, 385 children, 3 to 18 years of age, with chronic kidney disease (glomerular filtration rate of 15 to 80 ml per minute per 1.73 m2 of body-surface area) received ramipril at a dose of 6 mg per square meter of bodysurface area per day…
Zofenopril is a cost-effective treatment for patients with left ventricular systolic dysfunction following acute myocardial infarction: a pharmacoeco…
2013
Objective: The Survival of Myocardial Infarction Long-term Evaluation 4 Study (SMILE-4) showed the superiority of Zofenopril (Z) associated with Acetylsalicylic Acid (ASA) as respect to Ramipril (R) plus ASA in reducing the occurrence of major cardiovascular events, in patients with left ventricular dysfunction (LVD) following Acute Myocardial Infarction (AMI). The objective of this retrospective analysis was the evaluation of cost-effectiveness of Z compared to R. Methods: 771 patients with LVD and AMI were randomized, double-blind to Z 60 mg/day (n=389) or R 10 mg/day (n=382) plus ASA 100 mg/day and followed-up for 1 year. The primary study end-point was 1-year combined occurrence of deat…
Peri-operative red blood cell transfusion in neonates and infants: NEonate and Children audiT of Anaesthesia pRactice IN Europe: A prospective Europe…
2022
BACKGROUND Little is known about current clinical practice concerning peri-operative red blood cell transfusion in neonates and small infants. Guidelines suggest transfusions based on haemoglobin thresholds ranging from 8.5 to 12���g���dl-1, distinguishing between children from birth to day 7 (week 1), from day 8 to day 14 (week 2) or from day 15 (���week 3) onwards. OBJECTIVE To observe peri-operative red blood cell transfusion practice according to guidelines in relation to patient outcome. DESIGN A multicentre observational study. SETTING The NEonate-Children sTudy of Anaesthesia pRactice IN Europe (NECTARINE) trial recruited patients up to 60 weeks' postmenstrual age undergoing anaesthe…
Refraktiver Nutzen und inkrementelle Kosten der LASIK: Ergebnisse einer Kosten-Nutzen-Studie an zwei universitären LASIK-Zentren
2003
BACKGROUND No data is available to date on the cost effectiveness of laser in situ keratomileusis (LASIK) with regard to the German-speaking health care system. Hence we compared the clinical outcome and cost data of two German LASIK centres in respect of procedure cost effectiveness from the patient perspective. MATERIAL AND METHODS A retrospective cohort study was implemented at the University Hospitals of Mainz and Mannheim. Data on refractive outcome were obtained from the LASIK centres' patient documentation, cost data on the surgery as well as on eyeglasses etc. before and after the surgery were obtained from patient interviews. The primary endpoint of this investigation was the indiv…
IqYmune® is an effective maintenance treatment for multifocal motor neuropathy: A randomised, double‐blind, multi‐center cross‐over non‐inferiority s…
2018
Intravenous immunoglobulin (IVIg) is the gold-standard for maintenance treatment of multifocal motor neuropathy (MMN). This phase III, randomised, double-blind, multi-centre, active-control, crossover study, aimed to evaluate the non-inferiority of IqYmune® relative to Kiovig®, primarily based on efficacy criteria. Twenty-two adult MMN patients, treated with any brand of IVIg (except Kiovig® or IqYmune®) at a stable maintenance dose within the range of 1 to 2 g/kg every 4 to 8 weeks, were randomised to receive either Kiovig® followed by IqYmune®, or IqYmune® followed by Kiovig®. Each product was administered for 24 weeks. The primary endpoint was the difference between IqYmune® and Kiovig® …