Search results for "Randomized Controlled Trial"

Effects Of Whole Body Vibration In Patients With Chronic Obstructive Pulmonary Disease - A Randomized Controlled Trial

2012

Summary Introduction To date endurance and strength training are established and evidence-based exercise methods in patients with chronic obstructive pulmonary disease (COPD). There is an unmet need for further research in new and complementary exercise modalities. Additional whole body vibration training during pulmonary rehabilitation may be such a new approach that has not yet been investigated in patients with COPD. Methods Eighty-two patients (65 ± 9 yrs, FEV 1 pred. 38 ± 11%, female 51%) with COPD in GOLD stage III to IV assessed for a 3-week inpatient multidisciplinary rehabilitation program were on top randomly assigned to one of two intervention groups: (1) 3 × 3 min of bilateral d…

Cetuximab and gemcitabine in elderly or adult PS2 patients with advanced non-small-cell lung cancer: The cetuximab in advanced lung cancer (CALC1-E a…

2009

Background:Two parallel randomized phase 2 trialswere performed to choose the optimal way of combining cetuximab with gemcitabine in the first-line treatment of elderly (CALC1-E) and adult PS2 (CALC1-PS2) patients with advanced NSCLC. Methods: Stage IV or IIIB NSCLC patients, aged ≥70 years with PS 0–2 for CALC1-E or aged <70 with PS2 for CALC1-PS2, not selected for EGFR expression,were eligible. Patients were randomized to concomitant (gemcitabine, for a maximum of 6 cycles, plus cetuximab until progression) or sequential (gemcitabine, for a maximum of 6 cycles, followed by cetuximab) strategy. A selection design, with 1-year survival rate as the primary endpoint, was applied, requiring 58…

167P Chemotherapy-induced neutropenia and treatment efficacy in advanced non-small cell lung cancer (aNSCLC): A pooled analysis of 6 randomized trials

2021

Blinded 12-week comparison of once-daily indacaterol and tiotropium in COPD.

2011

Two, once daily (q.d.) inhaled bronchodilators are available for the treatment of chronic obstructive pulmonary disease (COPD): the β(2)-agonist indacaterol and the anticholinergic tiotropium. This blinded study compared the efficacy of these two agents and assessed their safety and tolerability. Patients with moderate-to-severe COPD were randomised to treatment with indacaterol 150 μg q.d. (n=797) or tiotropium 18 μg q.d. (n=801) for 12 weeks. After 12 weeks, the two treatments had similar overall effects on "trough" (24 h post-dose) forced expiratory volume in 1 s. Indacaterol-treated patients had greater improvements in transition dyspnoea index (TDI) total score (least squares means 2.0…

Efficacy and safety of tralokinumab in patients with severe uncontrolled asthma: a randomised, double-blind, placebo-controlled, phase 2b trial

2015

Summary Background Interleukin 13 is a central mediator of asthma. Tralokinumab is a human interleukin-13 neutralising monoclonal antibody. We aimed to assess the efficacy and safety of two dosing regimens of tralokinumab in patients with severe uncontrolled asthma. Methods We did a randomised, double-blind, placebo-controlled, parallel-group, multicentre, phase 2b study at 98 sites in North America, South America, Europe, and Asia. Patients aged 18–75 years with severe asthma and two to six exacerbations in the previous year were randomly assigned (1:1), via an interactive voice-response or web-response system, to one of two dosing regimen groups (every 2 weeks, or every 2 weeks for 12 wee…

Age does not affect the efficacy of anti-IL-5/IL-5R in severe asthmatics

2019

Background: Healthcare decisions made on the basis of insufficient evidence may potentially have ineffective or even harmful consequences. The proportion of older ages (over 65 years) in randomized controlled trials (RCTs) for severe asthma is not enough to establish whether anti-IL-5/IL-5R therapies are equally effective in the elderly as in younger subjects. Methods: In order to assess the relationship between age and the efficacy of anti-IL-5 monoclonal antibodies (mABs) with respect to the risk of exacerbations and changes in FEV1, a meta-regression analysis via random-effect method was carried out by plotting the effect estimates (outcome variables) resulting from the pairwise meta-ana…

2021

BACKGROUND Postoperative air leaks are a common complication after lung surgery. They are associated with prolonged hospital stay, increased postoperative pain and treatment costs. The treatment of prolonged air leaks remains controversial. Several treatments have been proposed including different types of sealants, chemical pleurodesis, or early surgical intervention. The aim of this review was to analyze the impact of autologous blood pleurodesis in a systematic way. METHODS A systematic review of the literature was conducted until July 2020. Studies with more than five adult patients undergoing lung resections were included. Studies in patients receiving blood pleurodesis for pneumothora…

Defining moderate asthma exacerbations in clinical trials based on ATS/ERS joint statement

2015

Background Exacerbations are a key outcome in clinical research, providing patient-relevant information about symptomatic control, health state and disease progression. Generally considered as an episode of (sub)acute deterioration of respiratory symptoms, a precise, clinically useful definition is needed for use in clinical trials. Aim and methods Focussing on moderate exacerbations, this opinion piece reviews landmark trials and current guidelines to provide a practical definition of a moderate exacerbation. Specifically, we adapt the ATS/ERS consensus statement of terminology Reddel et al. (2009) [1] which provides a conceptual (or 'theoretical') definition for moderate exacerbations, to…

Timing of Renal Replacement Therapy for Severe Acute Kidney Injury in Critically Ill Patients

2019

Acute kidney injury (AKI) affects many ICU patients and is responsible for increased morbidity and mortality. Although lifesaving in many situations, renal replacement therapy (RRT) may be associated with complications, and the appropriate timing of its initiation is still the subject of intense debate. An early initiation strategy can prevent some metabolic complications, whereas a delayed one may allow for renal function recovery in some patients without need for this costly and potentially dangerous technique. For years, most of the knowledge on this issue stemmed from observational studies or small randomized controlled trials. Recent randomized controlled trials have indicated that a w…

Challenges and perspectives in obstructive sleep apnoea: Report by an ad hoc working group of the Sleep Disordered Breathing Group of the European Re…

2018

Obstructive sleep apnoea (OSA) is a major challenge for physicians and healthcare systems throughout the world. The high prevalence and the impact on daily life of OSA oblige clinicians to offer effective and acceptable treatment options. However, recent evidence has raised questions about the benefits of positive airway pressure therapy in ameliorating comorbidities.An international expert group considered the current state of knowledge based on the most relevant publications in the previous 5 years, discussed the current challenges in the field, and proposed topics for future research on epidemiology, phenotyping, underlying mechanisms, prognostic implications and optimal treatment of pat…