SANI Clinical Remission definition: a useful tool in Severe Asthma management.

In the field of severe asthma, the concept of disease control has recently been integrated by the one of clinical remission. With this new concept, we move on to analyze the efficacy of therapy on multiple parameters simultaneously, starting with the mandatory discontinuation of the systemic glucocorticoids, to which is added the effect on exacerbations, respiratory function, and symptoms control. The Italian severe asthma registry SANI (Severe Asthma Network Italy) drafted criteria for the definition of disease remission, allowing patients to be classified into two groups, partial and complete remission. The greater dynamism of the definition, provided by SANI, allows us to hypothesize its practical use, concerning therapy management of severe asthma patients, starting from the level of remission, with the aim to facilitate the clinical decision on replacement, continuation or modulation of patients' therapy.

COVID-19 after 2 Years from Hospital Discharge: A Pulmonary Function and Chest Computed Tomography Follow-Up Study.

INTRODUCTION: Serial follow-up with pulmonary function testing (PFT) and chest computed tomography (CT) after severe COVID-19 are recommended. As a result, many longitudinal studies have been published on COVID-19 of different grade of severity up to 1-year follow-up. Therefore, we aimed at a long-term observational study throughout 2 years after severe COVID-19. METHODS: Severe COVID-19 patients were consecutively recruited after hospital discharge between March and June 2020 and prospectively followed up for 24 months, with mMRC dyspnea scale and PFT at 6, 12, and 24 months. Chest CT was performed when clinically indicated. RESULTS: One hundred one patients enrolled completed the observational study. At 24 months, those with reduced total lung capacity (TLC) were 16%, associated with fibrotic ground glass opacity (GGO) and mMRC score >1, respectively, in 75% and 69% of them. At 24 months, those with a reduced diffusing capacity of the lung for CO were 41%, associated with fibrotic GGO and mMRC score >1, respectively, in 53% and 22% of them. CONCLUSION: Two years after hospitalization for severe COVID-19, a non-negligible number of patients still suffer from "long COVID" due to respiratory damage.

A narrative review on asthma and pest sensitization (cockroach, mouse and rat allergens): a social issue besides the medical problem.

OBJECTIVE: Among animals defined as "pests", cockroaches and rodents (mouse and rat) represent the most common cause of airway allergic sensitization and bronchial asthma worldwide. Their frequency of sensitization has been widely assessed in US and other countries but poorly in Western Europe. This narrative review aims to provide a synthesis of data resulting in MEDLINE concerning allergic sensitization/asthma to pests as well as their related environmental/social risk factors, specifically in the European area. DATA SOURCES: We performed a literature research in MEDLINE for clinical trials, randomized controlled trials, systematic reviews and meta-analyses. STUDY SELECTIONS: We selected studies to the following key words: allergic sensitization, allergic rhinitis, bronchial asthma, cockroach, hypersensitivity, integrated pest management, material hardship, medication compliance, mouse, pest, poverty, rat, rodents. RESULTS: Current evidence indicates that residence in poor and urban areas, exposure to outdoor/indoor pollutants and tobacco smoke, poverty, material hardship, poor-quality housing, differences in health care quality, medication compliance, health care access contribute to increased pest-related allergic sensitization and asthma morbidity. CONCLUSION: Further research should be done on many aspects of pest allergy such as a better characterization of allergens and epidemiological aspects. Relevant social actions should be carried out against poverty, healthcare disparities, psycho-social stress, poor compliance to therapy, with economic contributions to improve private and public living environments. Allergic sensitization to pests and pest-allergic respiratory diseases like asthma are "paradoxical" conditions, as they typically affect the poorest communities but can only be corrected by high-cost (diagnostic and preventive) interventions. We hope that progress can be made in this direction in the future.

Mild/Moderate Asthma Network in Italy (MANI): a long-term observational study.

OBJECTIVE: The prevalence of asthma in Italy is estimated to be around 4%; it affects approximately 2,000,000 citizens, and up to 80-90% of patients have mild-to-moderate asthma. Despite the clinical relevance of mild-to-moderate asthma, longitudinal observational data are very limited, including data on disease progression (worsening vs. improvement), the response to treatment, and prognosis. Studies are needed to develop long-term, observational, real-life research in large cohorts. The primary outcomes of this study will be based on prospective observation and the epidemiological evolution of mild and moderate asthma. Secondary outcomes will include patient-reported outcomes, treatments over time, disease-related functional and inflammatory patterns, and environmental and life-style influences. METHODS: This study, called the Mild/Moderate Asthma Network of Italy (MANI), is a research initiative launched by the Italian Respiratory Society and the Italian Society of Allergology, Asthma and Clinical Immunology. MANI is a cluster-based, real world, cross-sectional, prospective, observational cohort study that includes 20,000 patients with mild-to-moderate asthma. (ClinicalTrials.gov Identifier: NCT04796844). RESULTS AND CONCLUSION: Despite advances in asthma care, several research gaps remain to be addressed through clinical research. This study will add important new knowledge about long-term disease history, the transferability of clinical research results to daily practice, the efficacy of currently recommended strategies, and their impact on the burden and evolution of the disease. ABBREVIATIONS: MANI:Mild/Moderate Asthma Network of ItalySANI:Severe Asthma Network ItalyGINA:Global Initiative for AsthmaSABA:short acting ß2-agonistsICS:inhaled corticosteroidsCRF:Case Report Form.

Use of face masks and allergic nasal symptoms: Why not mention pollen count and air pollution data?

The scientific quantification of symptoms in pollen-related allergic rhinitis cannot be separated from the aerobiological data of the geographical area in which the study was carried out.

Anxiety and depression in adolescents with asthma and in their parents. Is an increased basal cholinergic tone a possible further reason to explain the negative impact on asthma control?

To the Editor We read with interest the excellent article of Licari et al.  reporting that anxiety and depression are common in adolescents suffering from asthma as well as in their parents, mainly in mothers. The consequence of this relationship is that emotional disorders might negatively affect also the control of asthma.

Analysis of the drop-out rate in patients receiving mepolizumab for severe asthma in real life.

Mepolizumab (anti IL-5, monoclonal antibody) is commercially available in Italy since more than one year for the treatment of severe hypereosinophilic asthma. Its efficacy and safety were evaluated in several regulatory trials. The characteristics of this drug in real life began to be assessed only recently. We describe herein the drop-out rate observed with mepolizumab in real life, because this datum can indirectly reflect the safety and tolerability aspects. The demographic and clinical data of patients receiving mepolizumab for severe asthma were collected, and the number and reasons for discontinuation of the treatment were analyzed. The database involves 143 patients (67 male, age range 19-80 year) who received at least one dose of mepolizumab. The observed discontinuation rate was 6/143 (4.2%). Five out of 6 discontinuations were due to lack of response, and one was an adverse event (urticaria) probably related to the treatment. There was no clinical difference between the drop-out group and the patients still ongoing. As compared to the clinical trials published the discontinuation rate was lower in our population, especially for adverse events (7% vs 23.7%). Thus, the tolerability of mepolizumab, as derived from discontinuations, seems to be better in real-life than in clinical trials.

One year of mepolizumab. Efficacy and safety in real-life in Italy.

BACKGROUND: Severe asthma is a disease with a heavy socio-economic burden and a relevant impact on the life of patients. Mepolizumab (MEP) was recently introduced in practice. The previous data were favourable as efficacy and safety are concerned. Nowadays, we can report the clinical data after more than one year of use of MEP in the real-life setting. OBJECTIVE: To evaluate the efficacy and safety of MEP in a real life framework, mainly concerning asthma exacerbations, steroid dependence, effects on respiratory function and adverse events. METHODS: This retrospective analysis was performed on 138 patients, treated with MEP for at least 12 months, and referred to eleven severe asthma clinics in Italy. All patients met the criteria for severe uncontrolled asthma according to ATS/ERS guidelines and prescribing MEP conditions according to the Italian Drug Agency (AIFA). RESULTS: We could observe 138 patients (78 female, age 58 ±â€¯10 years). The average age of onset of asthma was 34 ±â€¯16 years. The blood eosinophil count decreased from 822 ±â€¯491/µL at baseline to 117 ±â€¯96/µL (p < .0001) after 12 months of therapy. Exacerbations decreased from 3.8/year to 0.7/year (-81%; p < .0001). Steroid-dependent patients before MEP (80%) with a daily dose of 10.1 ±â€¯9.4 mg prednisone decrease at 28% after 12 months with a mean of 2.0 ±â€¯4.2 mg/day (p < .0001). The occurrence of adverse events was overall low. CONCLUSIONS & CLINICAL RELEVANCE: In this real-life setting, MEP confirmed its efficacy and safety profile, already shown in clinical trials. This was apparent concerning exacerbation rate, systemic steroids intake and safety.

Asthma, exercise and metabolic dysregulation in paediatrics.

Asthma is the most frequent chronic disease in childhood. Chest tightness, cough, wheezing and dyspnoea during or after exercise may be unique manifestations of asthma in up to 90% of subjects. Physical activity may be reduced by uncontrolled asthma symptoms and parental beliefs, impairing physical fitness of asthmatic children. Clinicians working in the field of allergy are aware of evidence supporting the benefits of physical activity for patients with asthma. Treatment of asthma is required in order to obtain its control and to avoid any limitation in sports and active play participation. As exercise performance in children with controlled asthma is not different from that of healthy controls, any exercise limitation cannot be accepted. Overweight and obesity may interfere with asthma and exercise, leading to dyspnoea symptoms. Evidences on the effect of insulin resistance on airway smooth muscle and on bronchial hyperactivity are presented. CONCLUSION: Exercise is part of the strategy to obtain the best control of asthma in childhood, but we have to optimise the asthma control therapy before starting exercise programming. Furthermore, it is crucial to give best attention on the effects of obesity and insulin resistance, because they could in turn influence patients' symptoms.

Psychological Stress, Lung Function and Exacerbation Risk in COPD: Is an Increase of Cholinergic Tone a Possible Link?

at a glance: On the hypothesis that psychological distress might interfere with airway reactivity in patients suffering of mild to moderate COPD through a cholinergic-mediated-bronchial reflex.

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: <12, between 12 and 24, between 24 and 60 and >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 linear regression model, corrected for all confounding variables, a higher significant positive increase in FEV1% in subjects treated for 12-24 (ß = 9.49; p = 0.034) or 24-60 months (ß = 8.56; p = 0.043) was found when compared with subjects treated for a shorter period. Treatment duration was positively associated with a step down of the other associated therapies (OR: 1.013; p = 0.019). This association was more relevant (OR: 4.167; p = 0.005) when we considered Omalizumab treatment duration >60 months compared to the shorter therapy. In particular, the percentage of subjects that were taking Montelukast, LABAs and oral corticosteroids was lower in the group treated with Omalizumab for a longer period of time. CONCLUSION: In real-life, the positive Omalizumab response remained stable for over 60 months. Long term Omalizumab treatment may lead to a discontinuation of some associated medications and to a slowing down of FEV1 decline.

Appropriateness in allergic respiratory diseases health care in Italy: definitions and organizational aspects.

In a historical period in which sustainability of the National Health Service is mandatory because of the international economical situation, the limited available resources at national level and the tendency of passing from a "population medicine" model towards the concept of "individualized medicine", the debate on appropriateness of medical and surgical procedures is of central importance. The choosing wisely campaign, started in United States in 2012 and then spread all over the world, tries to summarize which are the most inappropriate procedures for each medical and surgical speciality; as far as allergic respiratory diseases, the most relevant Italian societies and the American Academy defined the allergological procedures with the highest probability of inappropriateness. In Italy, a recent decree of the Ministry of Health defined a list of more than 200 procedures that will be considered as inappropriate in certain conditions; many of these procedures concern allergology, including allergic respiratory diseases. In this commentary we discuss the above mentioned decree and the concept of appropriateness in the field of allergic respiratory diseases, trying to figure out some practical considerations based on the current health resources available in the field of allergology in Italy.

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 "practical/handy" by 90% of patients and "easy to use" by 89%. After the second test, in which patients received a demonstration of the correct inhalation maneuver, the percentage of patients scoring ≥ 7 increased to 93% for the first characteristic and was confirmed for the second, with no differences between the groups in terms of age, educational level, use of devices, and presence of arthritis/arthrosis. The mean time to explain the inhaler technique and to perform a correct inhalation was 1'38"± 1'37", and 70% of the respondents required less than 2 minutes, with no differences between the groups in terms of age, education level, use of devices, and presence of arthritis/arthrosis. In conclusion, Genuair® was well accepted and easy to use in a representative sample of the Italian population aged ≥ 65 years. These characteristics make it a valid choice in the elderly, thus enabling patients to better cope with the problems and difficulties that are common to this age group.

The perception of Obstructive Sleep Apnoea/Hypopnoea Syndrome (OSAHS) among Italian general practitioners.

BACKGROUND: Obstructive Sleep Apnoea/Hypopnoea Syndrome (OSAHS) is a common disorder in the general population but often underestimated and underdiagnosed. METHODS: This questionnaire-based study evaluated the overall level of knowledge about OSAHS among Italian General Practitioners (GPs), who are frequently involved in the management of this complex disease. This represents an interesting aspect, because GPs intercept many of the patients with OSAHS, in which C-PAP could be potentially indicated. Randomly-selected GPs were provided with questionnaires, which were then returned anonymously. RESULTS: 80 questionnaires have been validated; the participants in the sample examined were represented by 43 females and 37 males; the average age of participants was 51 years. The general knowledge on OSAHS is overall satisfactory among GPs; it is recognized by most of the GPs interviewed as pathology in constant increase, and associated with predisposing factors such as obesity. High blood pressure is perceived as an independent cardiovascular risk factor in patients with OSAHS, in line with the majority of international studies. The C-PAP has been identified as the care gold standard in patients with OSAHS, despite the lack of patient compliance in relation to this procedure, while polysomnography was found to be the main instrumental procedure used in the diagnostic workup of OSAS. The pulmonologist and a multidisciplinary team have been identified as the specialist figures of reference to which to direct the patient through the diagnostic workup. Respiratory therapists and nurses represent the role of educator in the proper management of the C-PAP in the opinion of 62% of respondents, while only 34% think that this role should be played by the GPs and/or other specialists. CONCLUSIONS: In conclusion, this survey about the perception of OSAHS among GPs in Italy highlighted a satisfactory overall knowledge of OSAHS and only few weak points.

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 conditions that, in conjunction with age-associated structural and functional changes of the lung, may contribute to complicate the management of asthma. The current review addresses the main issues related to the management of allergic asthma in the geriatric age. In particular, the paper aims at revising current pharmacological and non pharmacological treatments for allergic asthmatics of advanced ages, primarily focusing on their safety and efficacy, although most behaviors are an arbitrary extrapolation of what has been tested in young ages. In fact, age has always represented an exclusion criterion for eligibility to clinical trials. Experimental studies and real life observations specifically testing the efficacy and safety of therapeutic approaches in allergic asthma in the elderly are urgently needed.