Different skin prick test sensitization patterns do not influence the response to omalizumab in severe asthma
Oral CorticoSteroid sparing with biologics in severe asthma: A remark of the Severe Asthma Network in Italy (SANI)
According to the data derived from several national and international registries, including SANI (Severe Asthma Network Italy), and considering the strong impact that frequent or regular use of oral corticosteroid has on quality of life (QoL) of severe asthmatics, as well as on the costs for managing corticosteroid-related diseases, oral corticosteroid sparing up to withdrawal should be considered a primary outcome in the management of severe asthma. New biologics have clearly demonstrated that this effect is possible, with concomitant reduction in the rate of exacerbations and in symptom control. Then, there is no reason for using so frequently oral corticosteroid before having explored al…
Minimal clinically important difference for asthma endpoints: an expert consensus report
Minimal clinically important difference (MCID) can be defined as the smallest change or difference in an outcome measure that is perceived as beneficial and would lead to a change in the patient's medical management.The aim of the current expert consensus report is to provide a “state-of-the-art” review of the currently available literature evidence about MCID for end-points to monitor asthma control, in order to facilitate optimal disease management and identify unmet needs in the field to guide future research.A series of MCID cut-offs are currently available in literature and validated among populations of asthmatic patients, with most of the evidence focusing on outcomes as patient repo…
Suggestions for lung function testing in the context of COVID-19
The 2019 coronavirus disease (COVID-19) pandemic is currently a challenge worldwide. Due to the characteristics of lung function tests, the risk of cross infection may be high between health care workers and patients. The role of lung function testing is well defined for the diagnosis of various diseases and conditions. Lung function tests are also indispensable in evaluating the response to medical treatment, in monitoring patient respiratory and systemic pathologies, and in evaluating preoperative risk in cardiothoracic and major abdominal surgeries. However, lung function testing represents a potential route for COVID-19 transmission, due to the aerosol generated during the procedures an…
Effects of a structured educational intervention in moderate-to-severe elderly asthmatic subjects.
Background: Adherence to inhaled drugs is linked to patients’ satisfaction with their device, and an incorrect use can negatively affect the outcomes of asthma treatment. We speculated that this is particularly true in elderly asthmatic subjects. Aim: We performed a national pre-post interventional multicentre study, enrolling moderate-to-severe asthmatic subjects aged ≥65 years treated with fixed inhaled combination drugs by dry powder inhaler (DPI) or pressurized metered dose inhaler (pMDI). Adherence and critical errors were evaluated by means of validated questionnaires at first visit (V1) and after 3–6 months (V2). At V1, subjects underwent intensive training on the correct use of the…
Non respiratory symptoms in asthma as possible predictors of exacerbations
Anxiety 34 37 36 Headache 28 23 26 Abdominal pain 1 3 2 Weakness 13 4 9 Depression 5 0 3 Impaired sleep 4 8 7 Nicturia 7 0 5 Chest pain 11 7 9 Excitement 13 6 10 Nonlocalized pain 4 4 4 Hunger 3 4 3 Lack of appetite 5 5 5 Fever 1 3 2 Nausea 1 5 4 Urticaria 3 0 2 Palpitation 28 23 26 Heartburn 11 7 10 Generalized itching 22 30 25 Non respiratory symptoms in asthma as possible predictors of exacerbations Gennaro Liccardi, MD, Gennaro Baldi, MD, Adriano Berra, MD, Emanuela Carpentieri, MD, Marina Cutajar, MD, Maria D’Amato, MD, Mario Del Donno, MD, Bruno Del Prato, MD, Ilenia Folletti, MD, Federica Gani, MD, Domenico Gargano, MD, Domenico Giannattasio, MD, Michele Giovannini, MD, Antonio Infan…
Onset of effect and impact on health-related quality of life, exacerbation rate, lung function, and nasal polyposis symptoms for patients with severe eosinophilic asthma treated with benralizumab (ANDHI): a randomised, controlled, phase 3b trial
Background: ANDHI was done to assess the efficacy of benralizumab, including onset of effect and impact on health-related quality of life (HRQOL), exacerbation rate, lung function, and nasal polyposis symptoms. Methods: This phase 3b, randomised, double-blind, parallel-group, placebo-controlled ANDHI study was completed in adults (aged 18–75 years) with severe eosinophilic asthma with at least 2 exacerbations in the previous year, despite high-dose inhaled corticosteroid plus additional controllers, screening blood eosinophil counts of at least 150 cells per μL, and an Asthma Control Questionnaire 6 (ACQ-6) score of 1·5 or more. Patients who met eligibility criteria were randomly assigned (…
Factors reducing omalizumab response in severe asthma
Background: Despite adding Omalizumab to conventional therapy, several severe asthmatics still show poor disease control. We investigated the factors that may affect a reduced Omalizumab response in a large population of severe asthmatics. Methods: 340 patients were retrospectively evaluated. FEV1%, FVC%, Asthma Control Test (ACT), fractional exhaled nitric oxide (FENO), possible step-downs/step-ups of concomitant therapies, exacerbations, disease control levels, ICS doses and SABA use, observed at the end of treatment, were considered as a response to Omalizumab. Results: Age was an independent risk factor for a reduced response concerning FEV1%, FVC%, ACT and for a lower asthma control. O…
Choosing wisely: Practical considerations on treatment efficacy and safety of asthma in the elderly
The prevalence of asthma in the most advanced ages is similar to that of younger ages. However, the concept that older individuals may suffer from allergic asthma has been largely denied in the past, and a common belief attributes to asthma the definition of "rare" disease. Indeed, asthma in the elderly is often underdiagnosed or diagnosed as COPD, thus leading to undertreatment of improper treatment. This is also due to the heterogeneity of clinical and functional presentations of geriatric asthma, including the partial loss of reversibility and the lower occurrence of the allergic component in this age range. The older asthmatic patients are also characterized the coexistence of comorbid …
Severe asthma: One disease and multiple definitions
Abstract Introduction There is, so far, no universal definition of severe asthma. This definition usually relies on: number of exacerbations, inhaled therapy, need for oral corticosteroids, and respiratory function. The use of such parameters varies in the different definitions used. Thus, according to the parameters chosen, each patient may result in having severe asthma or not. The aim of this study was to evaluate how the choice of a specific definition of severe asthma can change the allocation of patients. Methods Data collected from the Severe Asthma Network Italy (SANI) registry were analyzed. All the patients included were then reclassified according to the definitions of U-BIOPRED,…
Smoking and Obesity Increase Airway Hyperesponsiveness Risk In the Elderly
Objective of our study was assessing whether smoking and obesity might affect airways hyperresponsiveness (AHR) differently in younger and older subjects and whether this influence might be due to their different impacts on baseline lung function values at different ages. Methods 3,903 consecutive adult subjects with normal lung function (1,920 males; mean age 35.1±16.2; median FEV1:97.3% of predicted [interquartile range (IQR):89.7-105.2] and FEV1/FVC:84.6% of predicted [IQR:79.8-89.2]), having performed a methacholine test, were considered. They were subdivided into three groups according to age (18-39, 40-64 and ≥65 years) and into different sub-groups according to body mass index (BMI) …
The EDUCA (Elderly and Device Use in Chronic Asthma) multicentre Italian study on the assessment of errors and satisfaction in using the inhalers in elderly asthmatics: Preliminary results
Background: The incorrect use of inhalers can negatively affect the outcomes of asthma treatment. We assessed whether, and to what extent, this is the case in elderly asthmatics. Methods: This is an observational, multicentre Italian study enrolling mild-to-severe asthmatic patients aged ≥65 yrs treated with inhaled drugs, by DPI or pressurized MDI (pMDI). Critical errors, patient9s satisfaction with their inhaler and adherence were evaluated by means of validated questionnaires; the patients were also trained to a correct use of their device. After 3 to 6 months patient were revaluated. Results: To date, 312 patients have been included (41% males, median age 71 yrs). At least one critical …
Genuair® Usability Test: Results of a National Public Survey of the Elderly
Proper use of inhaler devices may be problematic in elderly patients due to age-related difficulties. A survey was administered to elderly patients to investigate the usability of the Genuair® device and patients' subjective viewpoint on the device. A representative sample of the Italian population aged ≥ 65 years was completed with a pre-defined sample of 89 patients with hand arthritis/arthrosis. Of 526 respondents, 88 were not self-sufficient. Only the replies of the 438 self-sufficient respondents were analyzed. A total of 107 participants (24%) reported having respiratory diseases, and 81 of these (76%) were users of inhaler devices. After the first test, the device was considered “pra…
Cabbage and fermented vegetables: from death rate heterogeneity in countries to candidates for mitigation strategies of severe COVID-19
International audience; Large differences in COVID-19 death rates exist between countries and between regions of the same country. Some very low death rate countries such as Eastern Asia, Central Europe, or the Balkans have a common feature of eating large quantities of fermented foods. Although biases exist when examining ecological studies, fermented vegetables or cabbage have been associated with low death rates in European countries. SARS-CoV-2 binds to its receptor, the angiotensin-converting enzyme 2 (ACE2). As a result of SARS-CoV-2 binding, ACE2 downregulation enhances the angiotensin II receptor type 1 (AT1 R) axis associated with oxidative stress. This leads to insulin resistance …
Can the response to Omalizumab be influenced by treatment duration? A real-life study
Objective It is unknown whether Omalizumab effectiveness changes over the course of time. Our retrospective real-life study tried to analyze whether Omalizumab response may be influenced by treatment duration. Methods 340 severe asthmatics treated with Omalizumab for different periods of time were recruited. They were subdivided into 4 groups according to the Omalizumab treatment length: 60 months. Omalizumab treatment results (FEV1, exacerbations, ACT, SABA use, asthma control levels, medications used e and ICS doses) were compared. Results ACT, exacerbations, GINA control levels, ICS doses and SABA use were similar in all groups with different Omalizumab treatment durations. Using a linea…
Economic impact of mepolizumab in uncontrolled severe eosinophilic asthma, in real life
Abstract Background and aims Severe asthma is burdened by frequent exacerbations and use of oral corticosteroids (OCS) which worsen patients’ health and increase healthcare spending. Aim of this study was to assess the clinical and economic effect of adding mepolizumab (MEP) for the treatment of these patients. Methods Patients >18 years old, referred to 8 asthma clinics, starting MEP between May 2017 and December 2018, were enrolled and followed-up for 12 months. Information in the 12 months before mepolizumab were collected retrospectively. The evaluation parameters included: OCS use, number of exacerbations/hospitalizations, concomitant therapies, comorbidity, and annual number of workin…