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Abstract Background Chronic urticaria (CU) is defined as recurrent urticaria lasting for more than 6 weeks. Objectives We aimed to characterize the phenotypes of patients with CU refractory to standard dose anti-H1 antihistamine treatment and search for clinical predictors of poor disease control. Methods Retrospective collection of data regarding clinical characteristics, comorbidities, treatment, and disease control of all adult refractory CU patients presenting to the Allergy and Immunology Department during 1 year. Results Sixty-one adult patients were included, 74% females, average age 44.5 years (18 to 84 years old). Most patients (78.7%) had initiated CU less than 1 year before enrolment. Chronic spontaneous urticaria (CSU) accounted for 55.7% of the patients, CSU associated with chronic inducible urticaria (CIndU) as a comorbidity for 44.3%, and angioedema was present in 55.7%. Medically-confirmed psychiatric disorders were present in 78.7%. Complementary diagnostic tests were performed in cases with more severe presentation (UAS7 ≥ 28 and/or UCT 1 year), corresponding to 42 tested patient. Evidence for autoimmunity (positive anti-thyroid peroxidase antibodies, anti-nuclear antibodies or autologous serum test) was found in 45.2% (n = 19/42), and high C-reactive protein was present in 14.3% (n = 6/42), half of these also had positive antinuclear antibodies. Forty-six patients (75.4%) had at least one significant exacerbation, requiring medical appointment, emergency room, hospitalization or job absenteeism. The number of exacerbations correlated with the presence of angioedema (p = 0.022), with a recent diagnosis (

Abstract Background Asthma affects the lives of hundred million people around the World. Despite notable progresses in disease management, asthma control remains largely insufficient worldwide, influencing patients’ wellbeing and quality of life. Poor patient handling of inhaling devices has been identified as a major persistent problem that significantly reduces inhaled drugs’ efficacy and is associated with poor adherence to treatment, impairing clinical results such as asthma control and increasing disease-related costs. We herein review key research and development (R&D) innovation in inhaler devices, highlighting major real-world critical errors in the handling and inhalation technique with current devices and considering potential solutions. Furthermore, we discuss current evidence regarding breath-triggered inhalers (BTI). Main body The two most common significant problems with inhalers are coordinating actuation and inhalation with pressurized metered-dose inhalers (pMDIs), and the need to inhale forcibly with a dry powder inhaler. BTI R&D plans were designed to overcome these problems. Its newest device k-haler® has several other important features, generating a less forceful aerosol plume than previous pMDIs, with efficient drug delivery and lung deposition, even in patients with low inspiratory flow. The local and systemic bioavailability of fluticasone propionate and formoterol (FP/FORM) administered via k-haler® has been shown to be therapeutically equivalent when administered via the previous FP/FORM pMDI. This device requires very few steps and has been considered easy to use (even at first attempt) and preferred by the patients in a randomized crossover study. In our country, FP/FORM k-haler is available without additional costs compared to FP/FORM pMDI. All devices continue to require education and regular checking of the correct inhalation technique. Conclusion BTI R&D can bring advantage over current available inhalers, avoiding the two most common identified critical errors in inhalation technique. K-haler® BTI is currently available, without an increased cost, and approved for adolescents and adults with asthma in whom treatment with inhaled combined therapy with long-acting beta2-agonists and corticosteroids is indicated. Its attractive and practical design to facilitate its use has been awarded. K-haler® represents added value through innovation to fulfill actual asthma patient needs, thus with potential relevant impact in asthma management and effective control.

Abstract Background Chronic urticaria is defined as the appearance of urticarial lesions and/or angioedema during a period of more than six weeks. We aimed at developing the Portuguese version of the Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) and at testing its reliability and the content, construct and criterion validity. Methods The forward-backward approach to a linguistic equivalence was followed, after which a clinical review and a cognitive debriefing with patients were performed. The intraclass correlation coefficient checked test-retest reliability with patients filling the same questionnaire with one week apart and the Cronbach’s alpha indicator assessed the internal consistency. Construct validity was tested by an exploratory factor analysis and by hypothesis tests involving sociodemographic and clinical patient characteristics, including the urticaria control test (UCT). On the other hand, criterion validity was tested through correlations with the Short-Form Health Survey SF-36, EQ-5D-5 L, and the Dermatology Quality of Life Index (DLQI). Results A total of 162 patients from seven hospital units were included. The mean (standard deviation) age was 42.6 (13.3) and 81.6% were female. CU-Q2oL was entirely filled by all respondents. Internal consistency was 0.947 for the overall score, ranging from 0.661 (limits) to 0.899 (sleep problems) and the corresponding reproducibility indicator was 0.910, based on 23 patients and ranging from 0.711 (swelling) and 0.957 (looks). Exploratory factor analysis in general confirmed the original structure originally obtained by the authors. All CU-Q2oL dimensions were highly correlated with DLQI Index and differentiated well between males and females, and between different levels of wheals and pruritus. In addition, moderate negative correlations were found between Cu-Q2oL scores and the dimensions from SF-36 and EQ-5D-5 L. Conclusions The satisfactory metric properties confirmed the cultural adaptation and validity of CU-Q2oL into Portuguese population, providing the clinicians with a valid tool to evaluate the impact of chronic urticaria on patient’s QoL and therefore adjust their treatment. Trial registration number Not applicable.