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

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bionorica SE

Criteria

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