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Cristoforo Incorvaia,1 Marcello Montagni,2 Elena Makri,1 Gian Galeazzo Riario-Sforza,1 Erminia Ridolo21Allergy/Pulmonary Rehabilitation, Istituti Clinici di Perfezionamento Hospital, Milan, Italy; 2Department of Clinical and Experimental Medicine, University of Parma, Parma, ItalyAbstract: β2-agonists were introduced in the 1940s as bronchodilators to be used in obstructive respiratory diseases. Long-acting β2-agonists have been a mainstay of bronchodilating treatment for decades. Recently, agents extending their effect to 24 hours and thus allowing the once-daily administration were introduced, defined as very-long-acting β2-agonists. Olodaterol is a new very-long-acting β2-agonist that has been shown, in controlled trials, to improve lung function as well as clinical outcomes and quality of life. Most of these trials included patients with moderate, severe, or very severe chronic obstructive pulmonary disease (COPD). Olodaterol has a rapid onset of action (comparable to formoterol) and provides bronchodilation over 24 hours. In controlled trials, olodaterol was shown to be as effective as formoterol twice daily, but significantly superior in terms of quality of life in patients with COPD. The safety profile of olodaterol was very good, with a rate of adverse events, including the cardiac events that are particularly important for β2-agonists, comparable to placebo. Also, the efficiency of the Respimat® device concurs to the effectiveness of treatment.Keywords: bronchodilators, β2-agonists, very long acting, olodaterol, efficacy, safety, COPD

Cristoforo Incorvaia,1 Marina Mauro,2 Marina Russello,2 Chiara Formigoni,3 Gian Galeazzo Riario-Sforza,1 Erminia Ridolo41Allergy/Pulmonary Rehabilitation, Istituti Clinici di Perfezionamento Hospital, Milan, Italy; 2Allergy Unit, 3Scientific Library, Sant'Anna Hospital, Como, Italy; 4Department of Clinical and Experimental Medicine, University of Parma, Parma, ItalyAbstract: A large number of trials show that the anti-immunoglobulin (Ig) E antibody omalizumab is very effective in patients with severe allergic asthma. This is acknowledged in consensus documents. The drug also has a good safety profile and a pharmacoeconomic advantage due to a reduction in the number of hospitalizations for asthma attacks. In recent years, some studies have shown that omalizumab is effective also in nonallergic asthma. Effects on the complex signaling mechanisms leading to activation of effector cells and to mediator release may account for this outcome. Indeed, omalizumab has been reported to be effective in a number of IgE-mediated and non-IgE-mediated disorders. Concerning the former, clinical efficacy has been observed in rhinitis, allergic bronchopulmonary aspergillosis, latex allergy, atopic dermatitis, allergic urticaria, and anaphylaxis. In addition, omalizumab has been demonstrated to be able to prevent systemic reactions to allergen immunotherapy, thus enabling completion of treatment in patients who otherwise would have to stop it. Concerning non-IgE-mediated disorders, omalizumab has been reported to be effective in nasal polyposis, autoimmune urticaria, chronic idiopathic urticaria, physical urticaria, idiopathic angioedema, and mastocytosis. Current indications for treatment with omalizumab are confined to severe allergic asthma. Consequently, any other prescription can only be off-label. However, it is reasonable to expect that the use of omalizumab will be approved for particularly important indications, such as anaphylaxis, in the near future.Keywords: hypersensitivity, immunoglobulin E, anti-IgE, omalizumab, asthma, atopic dermatitis, anaphylaxis, urticaria, mastocytosis

Erminia Ridolo,1 Marcello Montagni,1 Elisa Olivieri,1 Gian Galeazzo Riario-Sforza,2 Cristoforo Incorvaia2 1Department of Clinical and Experimental Medicine, University of Parma, Parma, 2Pulmonary Rehabilitation Unit, ICP Hospital, Milan, Italy Abstract: Bronchodilators are central drugs in the management of patients with chronic obstructive pulmonary disease (COPD). Indacaterol was the first agent of the novel family of very long-acting β2-agonists to be used as an inhaled bronchodilator for COPD and provides 24-hour therapeutic action, thus allowing once-daily administration. Data from clinical trials show that indacaterol has a bronchodilator effect similar to that of the anticholinergic tiotropium bromide and slightly higher efficacy compared with the long-acting β2-agonists, salmeterol and formoterol. Moreover, the safety profile is excellent and comparable with that of placebo. Concerning adherence with drug treatment and real-life management in respect to long-acting β2-agonists, once-daily dosing makes indacaterol more convenient for COPD patients and is likely to enhance patient adherence. Other very long-acting β2-agonists currently in development include vilanterol, olodaterol, and carmoterol, and these have shown good characteristics for clinical use in the studies reported thus far. Keywords: chronic obstructive pulmonary disease, bronchodilators, very long-acting β2-agonists

Paolo Scarpazza1, Cristoforo Incorvaia2, Paolo Amboni3, Giuseppe di Franco1, Stefania Raschi1, Pierfranco Usai1, Monica Bernareggi1, Cristiano Bonacina1, Chiara Melacini1, Roberta Cattaneo1, Serena Bencini1, Chiara Pravettoni2, Gian Galeazzo Riario-Sforza2, Gianni Passalacqua4, Walter Casali11Divisione di Broncopneumotisiologia, Ospedale Civile, Vimercate, Italy; 2Pulmonary Rehabilitation, Istituti Clinici di Perfezionamento, Milan, Italy; 3Clinical Chemistry Laboratory, Ospedali Riuniti, Bergamo, Italy; 4Allergy and Respiratory Diseases, University Of Genoa, Genoa, ItalyBackground: Noninvasive mechanical ventilation (NIMV) is an effective tool in treating patients with acute respiratory failure (ARF), since it reduces both the need for endotracheal intubation and the mortality in comparison with nonventilated patients. A particular issue is represented by the outcome of NIMV in patients referred to the emergency department for ARF and with a do-not-intubate (DNI) status because of advanced age or excessively critical conditions. This study evaluated long-term survival in a group of elderly patients with acute hypercapnic ARF who had a DNI order and who were successfully treated by NIMV.Methods: The population consisted of 54 patients with a favorable outcome after NIMV for ARF. They were followed up for 3 years by regular control visits, with at least one visit every 4 months, or as needed according to the patient’s condition. Of these, 31 continued NIMV at home and 23 were on long-term oxygen therapy (LTOT) alone.Results: A total of 16 of the 52 patients had not survived at the 1-year follow-up, and another eight patients died during the 3-year observation, with an overall mortality rate of 30.8% after 1 year and 46.2% after 3 years. Comparing patients who continued NIMV at home with those who were on LTOT alone, 9 of the 29 patients on home NIMV died (6 after 1 year and 3 after 3 years) and 15 of the 23 patients on LTOT alone died (10 after 1 year and 5 after 3 years).Conclusion: These results show that elderly patients with ARF successfully treated by NIMV following a DNI order have a satisfactory long-term survival.Keywords: COPD, acute respiratory failure, mortality rate, respiratory failure

Paolo Scarpazza,1 Cristoforo Incorvaia,2 Chiara Melacini,1 Roberta Cattaneo,1 Cristiano Bonacina,1 Gian Galeazzo Riario-Sforza,2 Walter Casali1 1Pneumology Unit, Ospedale Civile, Vimercate, 2Pulmonary Rehabilitation, Istituti Clinici di Perfezionamento, Milan, Italy Abstract: Noninvasive ventilation (NIV) was introduced as an alternative to invasive mechanical ventilation for acute respiratory failure caused from exacerbations of chronic obstructive pulmonary disease in the 1980s, and its use gradually rose worldwide. Seventy-eight patients (57 males, mean age 78.3 ± 9.2 years) undergoing NIV were evaluated. Of them, 48 (62.3%) had acute hypercapnic respiratory failure because of a chronic obstructive pulmonary disease exacerbation, and the remaining 30 had acute hypercapnic respiratory failure from other causes, mainly cardiac failure. All patients were treated by NIV using the bi-level positive airway pressure set up at high pressure/high backup rate. NIV was successful in 67 subjects (85.9%) and the patients were discharged, 57 of whom continued NIV at home and ten had spontaneous breathing. NIV was unsuccessful in eleven patients, ten of whom died and one was successfully treated by invasive mechanical ventilation. Significant differences were detected for a higher basal Glasgow Coma Scale score in successfully treated patients (P = 0.007), a higher basal Acute Physiology and Chronic Health Evaluation score in unsuccessfully treated patients (P = 0.004), and a lower pH after 1 hour in unsuccessfully treated patients (P = 0.015). These findings show a very high rate of success of NIV in patients with acute hypercapnic respiratory failure not only from chronic obstructive pulmonary disease but also from cardiac failure. This suggests that the use of invasive mechanical ventilation may be further reduced, with a decrease in its known complications as well. Keywords: invasive ventilation, noninvasive ventilation, acute respiratory failure