Background We designed the PROXIMA research (Patient-Reported Outcomes and Xolair? In the Management of Asthma) to determine the proportion of patients with severe asthma sensitive to perennial allergens, and to evaluate asthma control and treatment adherence up to 12?months in patients treated with omalizumab in Italian population. as per GINA guidelines, aged 18?years, needing a step up in therapy, and 2) a longitudinal phase on patients who will start omalizumab add-on therapy per clinicians judgment at baseline visit (approximately 180C240 patients). The primary variable of the cross-sectional phase is the proportion of patients with severe asthma presenting with perennial form of allergy (skin prick test or in vitro test). The primary variable of longitudinal phase is proportion of patients who achieve disease control (assessed by Asthma Control Questionnaire [ACQ]) with omalizumab at 6?months, and maintain it at 12?months. Secondary variables are patient compliance to omalizumab, patient-reported perception of cognitive and emotional impact of the illness, assessed by Brief Illness Perception Questionnaire (Brief IPQ) and the health related quality of life evaluated by the EuroQoL 5D-3?L (EQ-5D-3?L). BI6727 manufacturer Safety endpoints will be recorded during the course of the study. Patients participating in the longitudinal phase will be enrolled for ancillary study if they provide additional informed consent. Protein species in complex mixtures will be identified using innovative MudPIT (Multidimensional Protein Identification Technology) method. Conclusions The results of this observational study will provide estimate of patient population allergic to perennial allergens in Italy and information on patient-reported outcomes with omalizumab therapy in a real-world setting. The exploratory proteomic analysis on asthma biomarkers could eventually provide new data to identify responder patients to anti IgE therapy. strong class=”kwd-title” Keywords: Omalizumab, IgE, Severe allergic asthma, Perennial, BI6727 manufacturer Asthma control Background Asthma is a highly prevalent respiratory disorder characterized by chronic inflammation Rabbit polyclonal to TRIM3 and hyper-responsiveness of airways, and variable airflow obstruction, often reversible [1]. More than 300 million people are affected by asthma, worldwide [1,2]. Of this population, about 10% is estimated to have severe asthma accounting for significant burden of morbidity and mortality [3,4]. In Italian population (GEIRD Study), the median prevalence of asthma was reported to be 6.6%, ranging from 4.5%C8.5%, recording a 35% increase in the last 2 decades [5]. Clinically, many different forms or phenotypes of asthma have been recognized; however, allergic asthma affects a substantial proportion of patients with asthma [2]. Atopy and allergic mechanisms have been implicated for asthma in 50-80% of the patients and in approximately 50% of patients with severe asthma [6-8]. In Italy, allergic asthma affects 60% patients with BI6727 manufacturer asthma [5]. In patients with allergic asthma, who are already sensitized to a specific environmental allergen, contact with same BI6727 manufacturer allergen functions as powerful result in for asthmatic response, which can be mast-cellular powered in the first stage and inflammatory-cellular powered in past due phase [1,8]. Markedly increased degrees of IgE antibodies are located in people with allergic asthma. IgE antibodies cause persistent airway swelling via high-affinity (FcRI) or low-affinity (FcRII) IgE receptors present on effector cellular BI6727 manufacturer material such as for example mast cellular material, and basophils [1,8]. Antigen induced cross-bridging of IgE-FcRI cell surface area complexes, triggering degranulation of effector cellular material, provides rise to numerous symptoms of allergy. The distinction between perennial and seasonal allergic asthma tend to be made based on the seasonality of sensitizing allergens (seasonal and perennial) and the recognition IgE particular to allergen [8]. Nevertheless, distinction between seasonal and perennial allergic asthma predicated on seasonality of allergens is a subject for dialogue among clinicians due to certain overlapping features of allergens. Lately, it had been proposed to displace the conditions seasonal and perennial with the intermittent and persistent – disease or -publicity to allergens. The idea was designed to introduce modification in the procedure strategy for allergic illnesses considering the overlap between your treatment of seasonal and perennial allergic reactions. The new description was proposed as the idea of seasonality cannot be applied.