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

Acute Rhinosinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01146860
• Other study ID #: ARhiSi-2
• Secondary ID: 2009-016682-28
• Status: Completed
• Phase: Phase 3
• First received: June 7, 2010
• Last updated: June 28, 2013
• Start date: January 2010
• Est. completion date: April 2010

Study information

• Verified date: June 2013
• Source: Bionorica SE
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 386
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Rhinosinusitis
• Sinusitis

Intervention

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

Locations

Country	Name	City	State
Germany	Dr. Rainer Jund, Specialist in Otorhinolaryngology	Puchheim

Sponsors (1)

Lead Sponsor	Collaborator
Bionorica SE

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No