Efficacy and safety of VR475 (budesonide suspension delivered by the VR475 Inhalation System) as add-on treatment in patients with severe asthma (CLEARCUT Study)

VR475 has been developed for the treatment of severe asthma consisting of budesonide suspension administered by a breath-actuated nebuliser that enhances lung drug deposition through guiding slow flow and deep inhalation.Objectives: To evaluate efficacy, safety and tolerability of 2 VR475 doses administered BID for 52 weeks vs placebo (pbo) in uncontrolled asthmatics despite high dose inhaled corticosteroids and a second controller.Methods: A 52-week double-blind, parallel-group, pbo-controlled, study was conducted. Eligible patients were randomised 2:1:1:2 to VR475 1mg (n=238) or 0.5mg (n=119), pbo (n=119), or budesonide 1mg via conventional nebuliser (CN) (n=237). The primary endpoint was the annualised clinically significant exacerbation (CSE) rate.Results: 713 patients were randomised, 711 treated and 615 completed. CSE rates were low across all arms (0.2–0.28). VR475 showed a non-statistically significant reduction in the CSE rate vs pbo. Secondary endpoints indicated improved efficacy of VR475 vs pbo for FEV1 (wk 24:128 ml, p
Source: European Respiratory Journal - Category: Respiratory Medicine Authors: Tags: Airway pharmacology and treatment Source Type: research

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ConclusionsThis large observational study based on claims data reliably identified subjects with COPD treated with open TT and their burden on the NHS. Moreover, it could describe the real clinical management of the open TT, before the marketing of the fixed one. These findings are useful for health policymakers in order to promote the appropriate utilization of both currently marketed and future therapies.
Source: Pulmonary Pharmacology and Therapeutics - Category: Respiratory Medicine Source Type: research
Córdova P Abstract INTRODUCTION AND OBJECTIVES: Functional and inflammatory measures have been recommended to corroborate asthma diagnosis in schoolchildren, but the evidence in this regard is conflicting. We aimed to determine, in real-life clinical situation, the value of spirometry, spirometric bronchial reversibility to salbutamol (BDR), bronchial responsiveness to methacholine (MCT) and fractional exhaled nitric oxide (FENO), to corroborate the diagnosis of asthma in children on regular inhaled corticosteroids (ICS) referred from primary care. METHODS: One hundred and seventy-seven schoolchildren...
Source: Allergologia et Immunopathologia - Category: Allergy & Immunology Authors: Tags: Allergol Immunopathol (Madr) Source Type: research
We present a 48 year-old active duty physician who initially presented in 2007 with dyspnea and cough. Despite the absence of variable obstruction on spirometry, a clinical diagnosis of asthma was made. The patient's symptoms were temporized with inhaled corticosteroids and bronchodilators, titrated to his symptoms, until eventual therapeutic failure resulted in re-referral to pulmonary. Chest computed tomography (CT) showed ground-glass nodules and patchy airspace opacities with evidence of thoracic lymphadenopathy. A positron emission tomography CT (PET CT) showed diffuse adenopathy throughout his thorax and abdomen with...
Source: Respiratory Care - Category: Respiratory Medicine Authors: Tags: Respir Med Case Rep Source Type: research
Conclusion: In this group of pulmonologists confirmed COPD or ACO patients, a substantial proportion would be considered to have signs of asthma. In the personalized approach of airway disease management, these patients might benefit from ICS containing treatment. Prospective studies are needed to guide personalized care in this patient group.
Source: European Respiratory Journal - Category: Respiratory Medicine Authors: Tags: General practice and primary care Source Type: research
Introduction: there are no studies in steroid-dependent allergic asthma patients that demonstrate the oral corticosteroid (OC) sparing capacity of omalizumab or its histological benefits.Methodology: Open randomized study with two groups: OC + omalizumab (OMA G.) and OC alone (CG). At every monthly visit we recorded: accumulated and daily OC dose, exacerbations, spirometry, FeNO and adverse events. IgE measurement and bronchial biopsies were performed at baseline and after 12 months (immunohistochemical and EM).Results: 31 patients (17 OMA; 14 CG) without baseline differences. OC dose was reduced by 83% in OMA G. and by 9....
Source: European Respiratory Journal - Category: Respiratory Medicine Authors: Tags: Airway pharmacology and treatment Source Type: research
Conclusion: Using a clinical algorithm with mannitol challenge for assessment of fitness to dive in patients with possible asthma allowing re-challenge testing after stepping-up asthma therapy increased the proportion of individuals classified as fit for recreational SCUBA diving.
Source: European Respiratory Journal - Category: Respiratory Medicine Authors: Tags: Epidemiology Source Type: research
Background and Objective: Inhaled corticosteroids (ICS) might be overprescribed for COPD in general practice. Our aim was to identify predictors for prescribing ICS for COPD patients with or without asthma in general practice.Methods: Participating general practitioners (GPs) (n=144) recruited patients with COPD (ICPC 2nd ed. code R95) and currently prescribed ICS (ACT code R03AK and R03BA). Data on demographics, smoking habits, spirometry, dyspnea score, and exacerbation history were retrieved from medical records. Pearson Chi-Square test was used for comparison of categorical variables and logistic regression analysis wa...
Source: European Respiratory Journal - Category: Respiratory Medicine Authors: Tags: General practice and primary care Source Type: research
Conclusions: The difference, in commonly reported ICS sensitive parameters, was minimal between subjects with sustained AHR to mannitol and those whose AHR was abolished after 18wks of ICS. These findings suggest that measurements of asthma control, airway calibre and FeNO are not adequate to confirm optimal ICS therapy and the measurement of AHR to mannitol is a more useful guide to treatment with ICS.
Source: European Respiratory Journal - Category: Respiratory Medicine Authors: Tags: Monitoring airway disease Source Type: research
Conclusion: Difficult to control asthma is more predominant in asthmatic patients with elder age, obesity, smoking history and poor pulmonary functions.
Source: European Respiratory Journal - Category: Respiratory Medicine Authors: Tags: Airway pharmacology and treatment Source Type: research
Conclusion: A high proportion of COPD/Asthma patients are treated with oral medications in India. Even though 34% of patients are prescribed inhaled medications before they reach tertiary care, there is a preference for a ICS over LAMA in COPD and only 30% of Asthma patients were prescribed an ICS.
Source: European Respiratory Journal - Category: Respiratory Medicine Authors: Tags: General practice and primary care Source Type: research
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