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

• SNOT 20 symptom scores [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  Sino-Nasal Outcome Test (SNOT 20): 20 item questionnaire to assess the symptoms and emotional and social consequences of rhinosinusitis. The symptoms are assessed by the patient using a 6-point rating scale.
• Major Symptom Score assessed by the patient [ Time Frame: 14 days ] [ Designated as safety issue: No ]

  MSS: sum of the 5 main rhinosinusitis symptoms which are: rhinorrhea (anterior discharge), postnasal drip, nasal congestion, headache, facial pain/pressure.

  Each symptom is individually evaluated using the following 4-point rating scale (scoring system): 0 = none/not present, 1 = mild, 2 = moderate, 3 = severe.

  Thus the MSS ranges from a minimum of 0 to a maximum of 15 score points.

• Percentage of patients classified as responders by the investigator on a 4-point rating scale [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  General assessment of efficacy using a 4-point rating scale (symptoms healed, improved, unchanged, deteriorated). Patients whose symptoms are improved or healed will be classified as "responders" to treatment.
• Percentage of patients with signs of acute rhinosinusitis in ultrasonography of paranasal sinuses [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  Ultrasonography scans will be visually evaluated by the investigator for signs of 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.

• Drug: BNO 1016
  3x 160mg/day for 15 days p.o.
• Drug: Placebo
  3x /day for 15 days p.o.

• Experimental: BNO 1016
  Intervention: Drug: BNO 1016
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

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