Search

Background: The efficacy of neuraminidase inhibitors on improvement of respiratory symptoms triggered by influenza in patients with pre‐existing chronic respiratory diseases is unknown. Methods: This 2‐week, randomized, open‐label study evaluated intravenous peramivir 600 mg on two consecutive days (peramivir‐repeat), peramivir 300 mg single dose (peramivir‐single), and oral oseltamivir 75 mg twice daily for 5 days in patients with confirmed influenza and chronic respiratory diseases. Patients recorded symptom scores daily. The primary endpoint of cumulative area of time vs symptoms (CATVS) was expressed as an index value of area under the curve vs time of the total score of cough, sore throat, and nasal congestion from baseline to 2 weeks. Results: Of 214 randomized patients, 209 (56% female, 77% aged <65 years, 94% outpatients, 91% bronchial asthma, 62% influenza A) received ≥1 dose of study drug. Mean (standard deviation) CATVS was similar for peramivir‐repeat (782.78 [487.17]) vs peramivir‐single (717.35 [347.55]; P =.4371), and for peramivir‐repeat vs oseltamivir (856.34 [404.99]; P = 1.00). However, CATVS was significantly shorter for peramivir‐single vs oseltamivir, with an estimated treatment difference (TD) of −145.07 (95% confidence interval: −284.57, −5.56; P =.0416). In subgroup analyses, CATVS was significantly shorter for peramivir‐single vs oseltamivir among patients with influenza A (TD: −206.31 [−383.86, −28.76]; P =.0231), bronchial asthma (TD: −156.57 [−300.22, −12.92]; P =.0328), baseline respiratory severity score <5 (TD: −265.32 [−470.42, −60.21]; P =.0120), and age <65 (TD: −184.30 [−345.08, −23.52]; P =.0249). Conclusions: In patients with chronic respiratory diseases, peramivir‐single was not significantly different from peramivir‐repeat and was more effective than oseltamivir at alleviating respiratory symptoms. [ABSTRACT FROM AUTHOR]

Background and Objective: The Global initiative for chronic Obstructive Lung Disease (GOLD) Committee has proposed a chronic obstructive pulmonary disease (COPD) assessment framework focused on symptoms and on exacerbation risk. This study will evaluate a symptom and exacerbation risk-based treatment strategy based on GOLD in a real-world setting in Japan. Optimal management of COPD will be determined by assessing symptoms using the COPD Assessment Test (CAT) and by assessing the frequency of exacerbations., Methods: This study (ClinicalTrials.gov identifier: NCT01762800) is a 24-week, multicenter, randomized, double-blind, double-dummy, parallel-group study. It aims to recruit 400 patients with moderate-to-severe COPD. Patients will be randomized to receive treatment with either salmeterol/fluticasone propionate (SFC) 50/250 μg twice daily or with tiotropium bromide 18 μg once daily. Optimal management of patients will be assessed at four-weekly intervals and, if patients remain symptomatic, as measured using the CAT, or experience an exacerbation, they have the option to step up to treatment with both drugs, ie, SFC twice daily and tiotropium once daily (TRIPLE therapy). The primary endpoint of the study will be the proportion of patients who are able to remain on the randomized therapy., Results: No data are available. This paper summarizes the methodology of the study in advance of the study starting., Conclusion: The results of this study will help physicians to understand whether TRIPLE therapy is more effective than either treatment strategy alone in controlling symptoms and exacerbations in patients with moderate-to-severe COPD. It will also help physicians to understand the GOLD recommendation work in Japan.