2024 Volume 77 Issue 2 Pages 107-120
Introduction: Laninamivir octanoate inhalation powder is a treatment for influenza. Given that inhalation powder administration is difficult for some patients, a new formulation of laninamivir octanoate administered via a nebulizer inhaler was developed. This study evaluated the superiority and safety of a single inhaled dose of laninamivir octanoate using a nebulized inhaler versus placebo.
Methods: This randomized, single-blind, placebo-controlled, parallel-group, multicenter phase 3 study included patients aged ≥10 years with confirmed influenza A or B virus infection. Patients were randomized 1 : 1 to receive a single inhaled dose of laninamivir octanoate 160 mg inhalation solution (nebulizer inhaler) or placebo. The primary endpoint was influenza duration; the secondary endpoint was the time from the end of the Day 1 study visit to the first timepoint at which the patient’s body temperature was ≤36.9°C for at least 21.5 hr. Adverse events (AEs) were monitored for safety.
Results: In total, 534 patients were randomized. Median influenza duration was 55.3 hr (95% confidence interval [CI] 48.9, 68.8) and 73.6 hr (95% CI 67.8, 84.3) in the laninamivir octanoate and placebo groups, respectively (difference -18.3 hr [95% CI -23.6, -3.8]; P = 0.0048). Median time for body temperature to return to normal was 36.4 hr (95% CI 33.0, 41.3) and 51.4 hr, respectively (95% CI 45.7, 57.8; difference −15.0 hr [95% CI -18.6, -7.9]). No serious AEs, AEs leading to discontinuation, or deaths were reported.
Conclusions: In patients aged ≥10 years, laninamivir octanoate 160 mg nebulizer inhaler was effective against influenza A or B virus infection.
