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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Acute Rhinosinusitis

Intervention / Treatment
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* Drug: BNO 1016
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BNO 1016<br>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 | Drug: BNO 1016<br>* 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<br>* Other names: Sinupret extract;|
| Placebo Comparator: Placebo<br>sugar coated tablets with identical appearance to active treatment; frequency: 2 tablets t.i.d. duration: 15 days | Drug: Placebo<br>* sugar coated tablets with identical appearance to active treatment; frequency: 2 tablets t.i.d. duration 15 days<br>* Other names: Placebo to BNO 1016;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Symptom Score (MSS) Assessed by the Investigator | 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. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SNOT 20 Symptom Scores | 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: 0 = not present / no problem, 1 = very mild problem, 2 = mild or slight problem, 3 = moderate problem, 4 = severe problem, 5 = problem as bad as it can be. range: 0 to 100 | 14 days | 
| Major Symptom Score Assessed by the Patient | 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. | 14 days | 
| Percentage of Patients Classified as Responders by the Investigator on a 4-point Rating Scale | 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. Patients whose symptoms are unchanged or deteriorated as classified as non-responders. | 14 days | 
| Ultrasonography of Paranasal Sinuses | Percentage of patients with signs of acute rhinosinusitis in ultrasonography of paranasal sinuses will be evaluated. Ultrasonography scans will be visually evaluated by the investigator for signs of rhinosinusitis. | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BNO 1016, acute rhinosinusitis