Efficacy and Safety of Azelastine 0.15% Nasal Spray and Azelastine 0.10% Nasal Spray in Patients with Seasonal Allergic Rhinitis

Azelastine is a second-generation antihistamine approved for treatment of allergic rhinitis. This randomized, double-blind, placebo- and active-controlled, parallel-group clinical trial evaluated the efficacy and safety of azelastine 0.15% and azelastine 0.10% nasal spray at a dosage of 2 sprays/nostril twice daily in patients with moderate-to-severe seasonal allergic rhinitis (SAR). In total, 526 patients were randomized 1:1:1 to treatment with 2 sprays/nostril twice daily of azelastine 0.15%, azelastine 0.10%, or placebo. The primary efficacy variable was change from baseline in 12-hour reflective Total Nasal Symptom Score (TNSS; A.M. and P.M. combined), consisting of nasal congestion, rhinorrhea, itchy nose, and sneezing. After 2 weeks, the mean improvement and percentage improvement in the 12-hour reflective TNSS were significant (p < 0.001) with azelastine 0.15% and azelastine 0.10% compared with placebo. In a retrospective analysis, there was a statistical difference (p = 0.047) in the mean improvement versus placebo in the 12-hour reflective TNSS with azelastine 0.15% compared with azelastine 0.10%. Onset of action with azelastine 0.15% was within 30 minutes. Bitter taste was the most common adverse event with both azelastine 0.15% and azelastine 0.10% (8.4% and 9.4% of patients, respectively). Somnolence was reported by 1.7% of patients treated with azelastine 0.15%, 0.6% of patients treated with azelastine 0.10%, and 0.6% of patients treated with placebo. Azelastine 0.15% nasal spray at 2 sprays/nostril twice daily significantly improved the nasal symptoms associated with SAR with an onset of action within 30 minutes and was well tolerated

Efficacy and Safety of an Intravenous C1-Inhibitor Concentrate for Long-Term Prophylaxis in Hereditary angioedema

Background The plasma-derived, pasteurized, nanofiltered C1-inhibitor concentrate (pnfC1-INH) is approved in the United States as an intravenous (IV) on-demand treatment for hereditary angioedema (HAE) attacks, and, in Europe, as on demand and short-term prophylaxis. Objective This analysis evaluated Berinert Patient Registry data regarding IV pnfC1-INH used as long-term prophylaxis (LTP). Methods The international registry (2010–2014) collected prospective and retrospective usage, dosing, and safety data on individuals who used pnfC1-INH for any reason. Results The registry included data on 47 subjects (80.9% female subjects; mean age, 44.8 years), which reflected 4082 infusions categorized as LTP and a total of 430.2 months of LTP administration. The median absolute dose of pnfC1-INH given for LTP was 1000 IU (range, 500–3000 IU), with a median time interval between infusion and a subsequent pnfC1-INH–treated attack of 72.0 hours (range, 0.0–166.4 hours). Fifteen subjects (31.9%) had no pnfC1-INH–treated HAE attacks within 7 days after pnfC1-INH infusion for LTP; 32 subjects (68.1%) experienced 246 attacks, with rates of 0.06 attacks per infusion and 0.57 attacks per month. A total of 81 adverse events were reported in 16 subjects (34.0%) (0.02 events per infusion; 0.19 events per month); only 3 adverse events were considered related to pnfC1-INH (noncardiac chest pain, postinfusion headache, deep vein thrombosis in a subject with an IV port). Conclusion In this international registry, IV pnf-C1-INH given as LTP for HAE was safe and efficacious, with a low rate of attacks that required pnfC1-INH treatment, particularly within the first several days after LTP administration