Real-life Effectiveness of Omalizumab in Patients with Severe Allergic Asthma: RELIEF Study.

Introduction: Patients with severe allergic asthma (SAA) are at risk of severe exacerbations. Omalizumab is recommended as an add-on treatment for patients with uncontrolled SAA, despite high-dose inhaled corticosteroids and long acting ß2-agonist combination therapy (standard therapy).RELIEF was a prospective, open label, multicenter study conducted to assess the real-life effectiveness of omalizumab co-administered with standard therapy in patients with SAA for 24 months. Methods: A total of 347 patients aged ≥ 6 years with SAA were enrolled, 285 of whom (8 pediatrics and 277 adolescents and adults) completed this 24-month study. Compared with the 12 months prior to baseline, the mean number of exacerbations was reduced in the overall population at any time interval during the study. Proportion of patients with no exacerbations increased to 77.7% at 24 months from 32.6% at 12 months prior to baseline. A reduction in healthcare resource utilization was also observed. The mean number of specialist visits reduced from baseline (5.8 visits) to 2.4 visits at Month 24. Results: The mean asthma control test score was >19 at every time-point during the study. The rate of Global Evaluation of Treatment Effectiveness (GETE) for asthma response significantly increased at Months 18 and 24 (P <0.05) compared to baseline. Pulmonary function remained relatively stable for the overall study population. There were no new or unexpected safety findings in the study. Conclusion: RELIEF study showed that add-on therapy with omalizumab is effective in reducing exacerbations, healthcare utilization, and improving GETE score in patients with SAA uncontrolled by standard therapy.

Evaluation of the preference, satisfaction and correct use of Breezhaler® and Respimat® inhalers in patients with chronic obstructive pulmonary disease - INHALATOR study.

The INHALATOR study was a randomized, multicentre, open label, two-period of 7 days each, crossover study, with 7 days of washout in-between, aiming to evaluate the correct use, satisfaction and preference between Breezhaler® and Respimat® devices in patients under daily use of open Spiriva® or open Onbrize®, as monotherapy for treatment of mild or moderate COPD. Patients aged ≥40 years with a smoking history of at least 10 pack-year were included in the study. Primary endpoint was the rate of correct use of each device at the first day of treatment after reading the drug leaflet information and was evaluated under the supervision of a trained evaluator. At the end of each treatment phase, the inhaler use was re-evaluated and a satisfaction questionnaire was completed. The patients' preference for the inhaler devices was assessed at the end of the study. After exclusions due to screening failures, 140 patients were randomized: 136 received at least one dose of Breezhaler® and 135 of Respimat®. At treatment start, the rate of correct inhaler use was 40.4% (95%CI: 32.2%-48.7%) for Breezhaler® and 36.3% (95%CI: 28.2%-44.4%) for Respimat® (p = 0.451). After 7 days, the rates were 68.9% (95%CI: 61.1%-76.7%) and 60.4% (95%CI: 52.2%-68.7%), respectively (p = 0.077). According to the Feeling of Satisfaction with Inhaler Questionnaire - FSI 10 patients were more satisfied using Breezhaler® than Respimat® and 57.1% preferred using Breezhaler® (p = 0.001) while 30.1% preferred Respimat® (p < 0.001).

Sleep deprivation alters phosphorylated CREB levels in the amygdala: relationship with performance in a fear conditioning task.

We investigated the relationship between deficits in fear memory induced by sleep deprivation and pCREB expression in the basal and central nuclei of the amygdala. Sleep deprivation reduced pCREB expression in the central nucleus compared to control or sleep recovered groups, and in the basal nucleus only compared to sleep recovered group. Moreover, 24h of sleep recovery prior to training prevented changes in both pCREB expression and performance.