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

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, p...

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Autores principales: Sousa, Rita, Lakha, Deepak R., Brette, Sandrine, Hitier, Simon
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6966982/
https://www.ncbi.nlm.nih.gov/pubmed/32026411
http://dx.doi.org/10.1007/s41030-019-00100-w
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author Sousa, Rita
Lakha, Deepak R.
Brette, Sandrine
Hitier, Simon
author_facet Sousa, Rita
Lakha, Deepak R.
Brette, Sandrine
Hitier, Simon
author_sort Sousa, Rita
collection PubMed
description 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 (SPID(norm,0–3h)). Secondary efficacy endpoints included SPID 24 h after the first lozenge intake (SPID(norm,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 SPID(norm,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 SPID(norm0–3h) difference between ambroxol and placebo was −0.020 (0.025) (p = 0.443). Comparable results between treatment groups were also found for SPID(norm,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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s41030-019-00100-w) contains supplementary material, which is available to authorized users.
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spelling pubmed-69669822020-02-04 A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Ambroxol Hard-Boiled Lozenges in Patients with Acute Pharyngitis Sousa, Rita Lakha, Deepak R. Brette, Sandrine Hitier, Simon Pulm Ther Original Research 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 (SPID(norm,0–3h)). Secondary efficacy endpoints included SPID 24 h after the first lozenge intake (SPID(norm,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 SPID(norm,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 SPID(norm0–3h) difference between ambroxol and placebo was −0.020 (0.025) (p = 0.443). Comparable results between treatment groups were also found for SPID(norm,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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s41030-019-00100-w) contains supplementary material, which is available to authorized users. Springer Healthcare 2019-10-18 /pmc/articles/PMC6966982/ /pubmed/32026411 http://dx.doi.org/10.1007/s41030-019-00100-w Text en © The Author(s) 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any non-commercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Original Research
Sousa, Rita
Lakha, Deepak R.
Brette, Sandrine
Hitier, Simon
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Ambroxol Hard-Boiled Lozenges in Patients with Acute Pharyngitis
title A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Ambroxol Hard-Boiled Lozenges in Patients with Acute Pharyngitis
title_full A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Ambroxol Hard-Boiled Lozenges in Patients with Acute Pharyngitis
title_fullStr A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Ambroxol Hard-Boiled Lozenges in Patients with Acute Pharyngitis
title_full_unstemmed A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Ambroxol Hard-Boiled Lozenges in Patients with Acute Pharyngitis
title_short A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Ambroxol Hard-Boiled Lozenges in Patients with Acute Pharyngitis
title_sort randomized, double-blind, placebo-controlled study to assess the efficacy and safety of ambroxol hard-boiled lozenges in patients with acute pharyngitis
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6966982/
https://www.ncbi.nlm.nih.gov/pubmed/32026411
http://dx.doi.org/10.1007/s41030-019-00100-w
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