Pulmonary Therapy (Oct 2019)

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Ambroxol Hard-Boiled Lozenges in Patients with Acute Pharyngitis

  • Rita Sousa,
  • Deepak R. Lakha,
  • Sandrine Brette,
  • Simon Hitier

DOI
https://doi.org/10.1007/s41030-019-00100-w
Journal volume & issue
Vol. 5, no. 2
pp. 201 – 211

Abstract

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Abstract Introduction The aim of this study was to evaluate the efficacy and safety of a new hard-boiled lozenge formulation containing ambroxol 20 mg versus placebo for the relief of sore throat in patients with acute pharyngitis. Methods This was a phase 3, randomized, double-blind, placebo-controlled, parallel-group multicenter trial conducted between June and September 2018 in South Africa. Patients with a diagnosis of acute pharyngitis, onset ≤ 72 h, and sore throat pain of at least moderate intensity were randomized to receive either ambroxol 20 mg or placebo hard-boiled lozenges. The primary efficacy endpoint was the normalized time-weighted sum of pain intensity differences (SPID) from baseline over 3 h following administration of the first lozenge (SPIDnorm,0–3h). Secondary efficacy endpoints included SPID 24 h after the first lozenge intake (SPIDnorm,0–24h) and patient assessment of efficacy at 3 and 24 h after the first lozenge. Results Of 422 patients from 11 centers, 390 were randomized to one of the two treatment groups (n = 196, ambroxol; n = 194, placebo) and 388 were analyzed (modified intention-to-treat). The mean ± standard deviation SPIDnorm,0–3h values were −0.386 (0.259) and −0.366 (0.243) in the ambroxol and placebo groups, respectively, and the adjusted mean ± standard error SPIDnorm0–3h difference between ambroxol and placebo was −0.020 (0.025) (p = 0.443). Comparable results between treatment groups were also found for SPIDnorm,0–24h and patient assessment of efficacy at 3 and 24 h after the first lozenge. The incidence of treatment-emergent adverse events (TEAEs) was similar between treatment groups (11.7% for ambroxol versus 9.3% for placebo). Conclusion Although marked pain relief was observed over the first 3 h of treatment, superiority of ambroxol 20 mg hard-boiled lozenges versus placebo was not demonstrated in this study. Trial Registration NCT03583658. Funding Sanofi-Aventis Group.

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