3.2. Secondary endpoints of the study
sore throat, throat, pain
SORE THROAT, SECONDARY, PHARYNGEAL INFLAMMATION
A first pain relief (STRRS score ≥ 1) was perceived already at 1 minute after the administration of the benzydamine HCl spray and lozenge: high responder rates were recorded for both the treatment groups (m-ITT population: 77.9% for spray/87.4% for lozenges; PP population: 77.6% for spray/87.8% for lozenges), with significantly more responders in benzydamine HCl lozenges arm in comparison with benzydamine HCl spray arm (The prompt relief provided by the application of benzydamine HCl was also confirmed by the high responder percentage of patients reporting a meaningful ST relief (STRRS score ≥ 3). The percentage of patients who experienced a meaningful pain relief was considerable already at T5min after the single dose application and increased at T10min, with a peak at T15min and T30min and a decrease from T60min. However, at T120min, about half of the participants still showed significant pain relief in both the treatment arms. In the benzydamine HCl lozenges arm, the percentage of patients experiencing the ST relief was significantly higher at 5, 30 and 60 minutes post single-administration in comparison to the benzydamine HCl spray arm (Fig. Percentage of patients with a STRRS score ≥ 3 at different time points after a single dose administration of benzydamine HCl spray or benzydamine HCl lozenges as secondary endpoint of BePaiR study. A significant difference in the percentage of responders between the treatment with benzydamine HCl spray and benzydamine HCl lozenges was detected at 5, 30, and 60 min post dosing. A: PP population; B: m-ITT population. HCl = hydrochloride, m-ITT = modified intent-to-treat, STRRS = sore throat relief rating scale.At the end of the week of treatment, in the m-ITT population, the total improvement in STPIS average scores was by 70.41 mm ± 9.59 mm and 72.19 mm ± 9.86 mm in benzydamine HCl spray arm and in benzydamine HCl lozenges arm, respectively, also confirmed in the PP and the m-PP population analysis. A steady and statistically significant decrease in ST pain intensity until V2 was observed every day in both benzydamine HCl spray and benzydamine HCl lozenges arms and for PP, m-ITT and m-PP populations (Changes of STPIS total score (mean ± SD) versus baseline value at different time points of BePaiR study after administration of benzydamine HCl spray or benzydamine HCl lozenges. All changes of STPIS scores at different time points were statistically significant The TPA assessment in m-ITT population documented an improvement of the score from V0 to V2 by 8.38 ± 2.40 for benzydamine HCl spray arm and 8.47 ± 2.43 for benzydamine HCl lozenges arm (V2 vs V0, The SPID analysis of data from the SwoTS (0–120 minutes postdosing) revealed an improvement of the sensation of swollen throat of 46.15 mm ± 39.21 mm for benzydamine HCl spray and 52.27 mm ± 38.93 mm for benzydamine HCl lozenges in the m-ITT population and an improvement of 46.48 mm ± 39.88 mm for benzydamine HCl spray and 52.11 mm ± 38.98 mm for benzydamine HCl lozenges in the PP population For all items of the QuaSTI (listed in Table S1, Supplemental Digital Content 1, Moreover, TPA total score demonstrated that all features of pharyngeal inflammation had a statistically (Finally, results of the PSQ revealed that more than 90% of participants in m-ITT, PP and m-PP populations expressed a positive opinion regarding the study treatment. The majority of patients agreed/strongly agreed that the IMPs led to a rapid improvement of ST symptoms, both formulations were easy to use and suitable for daily use meeting the patient expectations.