Article
Multicentre, Randomised, Double-blind, Placebo-controlled Parallel-group Dose-Finding Study of Herbal Medicine (Dry Extract) BNO-1016 in Acute Rhinosinusitis
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Authors
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Claus Bachert
- Univ. Hospital, Dept. ENT, Gent, Belgium
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Martin Mondigler
- Bionorica SE, Neumarkt, Germany
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Hubert Steindl
- Bionorica SE, Neumarkt, Germany
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Holger Stammer
- Pharmalog GmbH, München, Germany
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Pontus Stierna
- Karolinska Institut, Stockholm, Sweden
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Herbert Eskötter
- Bionorica SE, Neumarkt, Germany
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Rainer Jund
- Praxis, Puchheim, Germany
| Published: | April 15, 2013 |
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| Published with erratum: | April 25, 2013 |
Outline
Text
Background: The aim of rhinosinusitis therapy is amelioration of symptoms and restoration of ventilation of nose and paranasal sinuses. BNO-1016 is a novel extract of five herbal drugs which are marketed as Sinupret® extract for rhinosinusitis.
Methods: In this randomised placebo-controlled clinical trial in line with EPOS guidelines, 455 patients with sonographically confirmed acute rhinosinusitis were treated with 480 mg, 240 mg or placebo for a total of 15 days. Primary endpoint was change in MSS (major symptom score: rhinorrhea, postnasal drip, nasal congestion, headache, facial pain/pressure; each scored 0–3) calculated as AUC across the entire treatment period. Other efficacy criteria encompassed single MSS criteria and MSS at end of treatment.
Results: The ITT analysis set comprised 444 adult patients (171 male / 273 female, mean age 40.1 years). Difference in AUC vs. placebo was 6.4 score points (6.9%, p=0.065) for 240 mg and 5.2 score points (5.6%, p= 0.102) for 480 mg BNO-1016. AUC of single symptom headache was significantly ameliorated (p=0.014) in the 480 mg BNO-1016 group vs placebo. The difference to placebo in MSS at end of treatment was 1.01 score points for 240 mg (p=0.051) and 1.77 score points for 480 mg (p=0.001) for the subgroup of patients with MSS≤12 and mild to moderate facial pain at baseline. No serious adverse events were reported. The tolerability of the study medication was rated as “very good” or “good” by more than 90% throughout all 3 groups by patients/ investigators.
Conclusion: The higher dose of 480 mg BNO-1016 showed a better improvement in specific symptoms of rhinosinusitis. As there was an excellent tolerability of both doses, the 480 mg dose was chosen for a subsequent confirmatory clinical trial on the efficacy of BNO-1016 vs placebo.
Supported by: Bionorica SE
Der Erstautor weist auf folgenden Interessenskonflikt hin: Wissenschaftlicher Berater der Bionorica SE
