Search results for "randomized"

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…

Eligibility of real-life patients with copd for inclusion in rcts: A commentary

2017

Randomized clinical trials (RCTs) are performed to provide evidence to support treatment decisions. Based on the nature of those studies and the need to avoid confounding factors, it has been argued that the population selected in RCTs only partially represents the real-life population. This assumption casts doubts on the applicability of the results provided by RCTs in the management of individuals with an established diagnosis of COPD, and advocates the need for complementary studies with a pragmatic design. Herein, we comment on the recent article published by Halpin and colleagues on the Journal [Halpin et al, Respir Res 17:120, 2016], in which higher rates of inclusions in RCTs for COP…

Riociguat treatment in patients with pulmonary arterial hypertension: Final safety data from the EXPERT registry

2021

OBJECTIVE: The soluble guanylate cyclase stimulator riociguat is approved for the treatment of adult patients with pulmonary arterial hypertension (PAH) and inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension following Phase 3 randomized trials. The EXPosurE Registry RiociguaT in patients with pulmonary hypertension (EXPERT) study was designed to monitor the long-term safety of riociguat in clinical practice. METHODS: EXPERT was an international, multicenter, prospective, uncontrolled, non-interventional cohort study of patients treated with riociguat. Patients were followed for at least 1 year and up to 4 years from enrollment or until 30 days after stopping ri…

Long-term volume-targeted pressure-controlled ventilation: sense or nonsense?

2017

The technology underlying the development of novel ventilatory modes for long-term noninvasive ventilation of patients with chronic hypercapnia is continuously evolving. Volume-targeted pressure-controlled ventilation is a hybrid ventilation mode designed to combine the advantages of conventional ventilation modes, while avoiding their drawbacks. However, manufacturers have created different names and have patented algorithms and set-up variables, which can result in confusion for physicians and respiratory therapists. In addition, clear evidence for the superiority of this novel mode has not yet been established. These factors have most likely hindered more widespread use of this mode in c…

Care pathways for the selection of a biologic in severe asthma.

2017

Physicians need care pathways to select a biologic in type 2 severe asthma (omalizumab, mepolizumab, reslizumab) http://ow.ly/pygw30gB7Bv

Clinical evidence from randomized trials, network meta-analyses, and conflicts of interests

2013

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…

Hybrid minimally invasive esophagectomy for esophageal cancer : less is more

2019

In a recently published multi-center randomized controlled trial ( New England Journal of Medicine 2019;380:152-162) Christophe Mariette and colleagues compared open transthoracic esophagectomy to hybrid esophagectomy (open thoracic phase, laparoscopic abdominal phase) for patients with resectable cancer of the middle or lower third of the esophagus (MIRO trial) (1).

The effect of tiotropium/olodaterol versus fluticasone propionate/salmeterol on left ventricular filling and lung hyperinflation in patients with COPD

2020

This exploratory, randomised, double-blind, double-dummy, multicentre, cross-over study explored the effect of 6 weeks of treatment with tiotropium/olodaterol (T/O) versus fluticasone propionate/salmeterol (F/S) on left ventricular filling in patients with chronic obstructive pulmonary disease with functional residual capacity (FRC) >120% predicted and postbronchodilator improvement of FRC ≥7.5%. Overall, 76 patients were randomised across nine sites. Treatment with T/O or F/S increased left ventricular end-diastolic volume index from baseline (adjusted mean change: T/O: 2.317 mL/m2, F/S: 2.855 mL/m2), with no statistically significant difference between treatments. However, T/O resulted…

Withdrawal of inhaled corticosteroids in COPD: A meta-analysis

2017

Background Conflicting findings exist on the benefit of withdrawal of inhaled corticosteroid (ICS) in chronic obstructive pulmonary disease (COPD). We performed a quantitative synthesis in order to assess real impact of ICS discontinuation in COPD patients. Methods We carried out a meta-analysis via random-effects model on the available clinical evidence to evaluate the effect of ICS discontinuation in COPD. Randomized clinical trials and observational real-life studies investigating the effects of ICS withdrawal on the risk of COPD exacerbation, lung function (forced expiratory volume in 1 s [FEV1]) and quality of life (St. George's Respiratory Questionnaire [SGRQ]) were identified by sear…