Efficacy and Safety of a Herbal Medicinal Product (Dry Extract BNO 1016) in Patients With Acute Rhinosinusitis

A Multi-centre, Double-blind, Placebo-controlled, Randomised, Parallel Group Study to Assess the Efficacy and Safety of a Herbal Medicinal Product (Dry Extract BNO 1016) in Patients With Acute Rhinosinusitis

The purpose of this study is to determine whether the dry extract BNO 1016 is effective and safe in the treatment of acute rhinosinusitis in adults.

The aim of this clinical study is to investigate the efficacy of a 15-days treatment with the herbal medicinal product BNO 1016 for therapy of acute rhinosinusitis in adult patients. Due to the considerable morbidity and the diminished quality of life experienced by people afflicted with acute rhinosinusitis an important aim of the treatment is to reduce the severity of rhinosinusitis symptoms and the duration of the disease. By grading the severity of the disease on the basis of the 5 main rhinosinusitis symptoms the investigator will assess the efficacy of the treatment.

Inclusion Criteria:

Diagnosis of acute rhinosinusitis

• characterized by a major symptom score (MSS) ≥ 8 and ≤ 12 points (minimum 0, maximum 15 points)
• individual score for facial pain/pressure ≥ 1 (mild) and ≤ 2 (moderate)
• confirmed by ultrasonography of paranasal sinuses
• with presence of symptoms ≤ 3 days prior to inclusion

Exclusion Criteria:

• Chronic rhinosinusitis
• Polyposis nasi
• Anatomical deviations of the nasal septum that significantly impair nasal and paranasal ventilation/airflow
• Acute symptoms of a known allergic rhinitis
• Patients with asthma who have a history of exacerbations within 30 days prior to study inclusion
• Signs or symptoms of fulminant bacterial sinusitis
• Odontogenic sinusitis