Comparative evaluation of rapidity of action of benzydamine hydrochloride 0.3% oromucosal spray and benzydamine hydrochloride 3 mg lozenges in patients with acute sore throat: A phase IV randomized trial.

Abstract

BACKGROUND:

Acute sore throat (ST) can occur as part of a common cold of viral origin or caused by pharyngeal bacterial pathogens. The majority of patients with acute ST complain of pain on swallowing and dry scratchiness which can have a negative impact on the quality of life (QoL). This study aimed to evaluate the time to pain relief in patients with acute ST, following a single administration of benzydamine hydrochloride (HCl) 0.3% oromucosal spray or benzydamine HCl 3 mg lozenges.

METHODS:

This multicenter, randomized, active-controlled, open label, parallel-group, international phase IV study was conducted at 12 investigational centers in Poland, Hungary, and Russian Federation. The study population consisted of 363 adult patients with recent onset (≤3 days) of ST and a diagnosis of tonsillopharyngitis. The primary endpoint was to assess the efficacy of benzydamine HCl in ST pain relief at 2 minutes after a single-dose administration. Secondary endpoints included, among others, the assessment of a first perceived ST relief at 1 minute after a single-dose administration of benzydamine HCl spray or lozenge.

RESULTS:

Both the spray and lozenges are effective in providing a ST relief starting already at 2 minutes after a single administration, with an effect lasting up to up to 4 hours. Clinical efficacy after 7 days of treatment and a good safety profile were also demonstrated.

CONCLUSION:

Anesthetic and analgesic properties of benzydamine spray and lozenges effectively addressed the patient priority of a rapid relief of symptoms of upper respiratory tract infections (URTI).

• Authors: Carmelina Valerio, Giorgio Di Loreto, Enrica Salvatori, Agnese Cattaneo
• Journal: Medicine (Medicine (Baltimore)) Vol. 102 Issue 13 Pg. e33367 (Mar 31 2023) ISSN: 1536-5964 [Electronic] United States
• PMID: 37000110 (Publication Type: Randomized Controlled Trial, Multicenter Study, Clinical Trial, Phase IV, Journal Article)
• Copyright: Copyright © 2023 the Author(s). Published by Wolters Kluwer Health, Inc.

Chemical References

• Benzydamine
• Tablets

Topics

• Adult
• Humans
• Benzydamine (therapeutic use)
• Quality of Life
• Common Cold (drug therapy)
• Pharyngitis (etiology)
• Tablets
• Pain (drug therapy)
• Double-Blind Method