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

Phase 3

Completed

• Conditions: Acute Rhinosinusitis
• Interventions: Drug: BNO 1016; Drug: Placebo

• Registration Number: NCT01146860
• Lead Sponsor: Bionorica SE

Brief 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.

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 Timeline

• Study Start: 2010-01
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Study First Submitted: 2010-06-07
• Study First Submitted QC: 2010-06-17
• Study First Posted: 2010-06-22
• Results First Submitted: 2012-10-09
• Status Verified: 2013-06
• Results First Submitted QC: 2013-06-28
• Last Update Submitted: 2013-06-28
• Results First Posted: 2013-08-02
• Last Update Posted: 2013-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 386

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BNO 1016	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
Placebo	Placebo	sugar coated tablets with identical appearance to active treatment; frequency: 2 tablets t.i.d. duration: 15 days

Primary Outcome Measures

Name	Time	Method
Major Symptom Score (MSS) Assessed by the Investigator	14 days	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.

Secondary Outcome Measures

Name	Time	Method
SNOT 20 Symptom Scores	14 days	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
Major Symptom Score Assessed by the Patient	14 days	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	14 days	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".
Ultrasonography of Paranasal Sinuses	14 days	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.

Trial Locations

Locations (1)

Dr. Rainer Jund, Specialist in Otorhinolaryngology; 🇩🇪 Puchheim, Germany