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

Bionorica

Status and phase: Completed; Phase 3

Conditions: Acute Rhinosinusitis

Treatments: Drug: BNO 1016; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01146860

ARhiSi-2

2009-016682-28 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 386 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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386 participants in 2 patient groups, including a placebo group

BNO 1016

Experimental group

Description:

sugar coated tablets with dry extract (80 mg) of 5 herbal drugs; dosage: 480 mg per day (2 tablets t.i.d.) duration: 15 days

Treatment:

Drug: BNO 1016

Placebo

Placebo Comparator group

Description:

sugar coated tablets with identical appearance to active treatment; frequency: 2 tablets t.i.d. duration: 15 days

Treatment:

Drug: Placebo