Table 1 Clinical studies of Sinupret

 Neubauer N, and März. 1994 [9]

Double-blind clinical trial

Patients with acute bacterial sinusitis showing an opacification of the plain sinus radiogram

n = 81 with Sinupret (BNO 101)

n = 79 with placebo

Primary outcomes:

Radiographic findings and patient assessment significantly favoured Sinupret to placebo

Exploratory outcomes:

Mucosal swelling, nasal obstruction, and headache scores were better with Sinupret than placebo

 Jund R, et al. 2012 [14] and Jund R, et al. 2015 [15]

Double-blind clinical trial

Patients with a diagnosis of acute viral rhinosinusitis confirmed by ultrasonography of the maxillary sinuses

ITT analysis [14]

n = 190 with Sinupret (BNO 1016)

n = 190 with placebo

Primary outcome:

The number of patients with investigator-assessed MSS ≤ 1 was 48.4% in the Sinupret group and 35.8% in the placebo group

(p = 0.0063). The NNT for patients to have MSS ≤ 1 was 8

Secondary outcomes:

Patient-assessed MSS, SNOT-20 GAV, and ultrasonography imaging were more favourable with Sinupret than placebo

PP analysis [14, 15]

n = 147 with Sinupret (BNO 1016)

n = 153 with placebo

Secondary outcome:

The investigator-assessed MSS score was 2.07 ± 0.18 in the Sinupret group and 3.47 ± 0.28 in the placebo group (p = 0.0001). The NNT for patients to have MSS ≤ 1 was 7

 Jund R, et al. 2015 [13]

Pooled analysis of two randomized clinical trials

Patients with a diagnosis of acute viral rhinosinusitis confirmed by ultrasonography of the maxillary sinuses

n = 294 with Sinupret (BNO 1016)

n = 295 with placebo

Primary outcome:

MSS improved during the treatment period by a mean of 10.02 ± 1.61 score points to 2.47 ± 2.55 for Sinupret and of 9.87 ± 1.52 to 3.63 ± 3.63 for placebo. Differences between treatment groups at end of therapy (1.16 ± 3.14 score points; p < 0.0001) was statistically significant in favour of Sinupret

Secondary outcome:

Patient-assessed quality of life at the end of treatment significantly favoured Sinupret (p = 0.0015)

 Passali D, et al. 2015 [16]

Open-label study

Patients with acute sinusitis as defined by EPOS 2012 guidelines

n = 30 with Sinupret Forte

n = 30 with fluticasone furoate

Primary outcome:

At Day 14, 66.7% and 50% of patients had a MSS ≤ 1 in the Sinupret and fluticasone groups,

respectively

Secondary outcome:

At Day 14, the SNOT-20 scores were 7.0 in the Sinupret group and 6.5 in the fluticasone group

 Weber U, et al. 2002 [17]

Non-randomized study

Patients with acute sinusitis

n = 30 with Sinupret/Cinnabaris 3X

n = 33 with conventional therapy

Main study outcomes

No clinically relevant differences were observed between the two groups on investigator-defined patients’ scores, physicians’ scores and quality of life