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.

Study Overview

• Status: Completed
• Conditions: Acute Rhinosinusitis
• Intervention / Treatment: Drug: BNO 1016; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 386
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Puchheim, Germany, 82178
    • Dr. Rainer Jund, Specialist in Otorhinolaryngology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bionorica SE
• Investigators: Study Chair: Rainer Jund, MD, Specialist in Otorhinolaryngology

Publications and helpful links

General Publications

• Jund R, Mondigler M, Steindl H, Stammer H, Stierna P, Bachert C; ARhiSi II study group. Clinical efficacy of a dry extract of five herbal drugs in acute viral rhinosinusitis. Rhinology. 2012 Dec;50(4):417-26. doi: 10.4193/Rhino.12.015.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: June 7, 2010
• First Submitted That Met QC Criteria: June 17, 2010
• First Posted (Estimate): June 22, 2010

Study Record Updates

• Last Update Posted (Estimate): August 2, 2013
• Last Update Submitted That Met QC Criteria: June 28, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: BNO 1016, acute rhinosinusitis
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis
• Other Study ID Numbers: ARhiSi-2; 2009-016682-28 (EudraCT Number)