Effect of peramivir on respiratory symptom improvement in patients with influenza virus infection and pre‐existing chronic respiratory disease: Findings of a randomized, open‐label study

Abstract

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Improvement of respiratory symptoms and health‐related quality of life with peramivir in influenza patients with chronic respiratory disease: Additional outcomes of a randomized, open‐label study

“…20,21 We recently reported the results of a multicenter, randomized, open-label, controlled study in Japan in which a single 300-mg dose of intravenous peramivir was more effective and faster to alleviate respiratory symptoms than oral oseltamivir in patients with chronic respiratory disease (primarily asthma) who had influenza. 22 Peramivir 300 mg single-dose, as well as 600 mg repeat-dose, was well tolerated in these patients. The main objective of the additional analyses reported here was to compare the effect of peramivir 300 mg single-dose, peramivir 600 mg repeat-dose, and oseltamivir on the mean change from baseline to Day 3 in CAT score (as an assessment of HRQoL), including respiratory symptoms and general conditions.…”

“…Here, we report additional outcomes from a 2-week, multicenter, randomized, open-label study conducted at 50 sites in Japan from October 2017 to February 2019. 22 The study was conducted in accordance with the Declaration of Helsinki, Ethical Guidelines for Medical and Health Research Involving Human Subjects, and the revised 2017 Clinical Trials Act. The protocol was approved by local ethical review boards.…”

“…Full study details have been previously described. 22 Key inclusion criteria were male or female inpatients or outpatients aged 16-79 years; diagnosis of influenza; total score of ≥ 3 for three respiratory symptoms (cough, sore throat, nasal congestion), including ≥ 1 for cough (four-grade scoring system: 0, no symptoms; 1, mild; 2, moderate; 3, severe); ≥1 general symptom (headache, muscle or joint pain, heat or chills, and fatigue) with score ≥ 2; maximum body temperature ≥ 37.5°C for ≥ 12 hours before screening; and undergoing treatment for a chronic respiratory disease (bronchial asthma, pulmonary fibrosis, or COPD, including diseases with emphysematous changes on chest computed tomography). Patients with chronic respiratory failure who had been under ventilator management, diabetes with glycated hemoglobin A1c ≥ 10% within 4 weeks before screening, or previous treatment with an NAI, amantadine hydrochloride, or baloxavir marboxil within the last 7 days were excluded.…”

“…The primary endpoint of the overall study was cumulative area of time vs symptoms (CATVS), assessed using an index area under the curve of the total score of three respiratory symptoms for 2 weeks. 22 The main efficacy endpoint in this report was the mean change from baseline to Day 14, evaluated at each time point, in total score and individual item scores of the CAT. The CAT comprises eight items (cough, phlegm, chest tightness, breathlessness, activities, confidence, sleep, and energy), each scored from 0 (no symptom, best condition) to 5 (worst/ severe condition), with total score from 0 to 40.…”

“…Complications associated with influenza infection, such as otitis and sinusitis, or mild exacerbations such as increased breath, cough, or phlegm that overlapped with influenza symptoms, were not evaluated as exacerbations. The mean change from baseline at Days 2, 3, and 14 in virus titer, measured as described previously 22 by influenza virus type and chronic respiratory disease, was calculated.…”