Back to resultsEfficacy and Safety of a Herbal Medicinal Product (Dry Extract BNO 1016) in Patients With Acute Rhinosinusitis
Primary Purpose
Acute Rhinosinusitis
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
BNO 1016
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Rhinosinusitis focused on measuring BNO 1016, acute rhinosinusitis
Eligibility Criteria
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
Sites / Locations
- Dr. Rainer Jund, Specialist in Otorhinolaryngology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BNO 1016
Placebo
Arm 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
sugar coated tablets with identical appearance to active treatment; frequency: 2 tablets t.i.d. duration: 15 days
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
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".
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01146860
Brief Title
Efficacy and Safety of a Herbal Medicinal Product (Dry Extract BNO 1016) in Patients With Acute Rhinosinusitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bionorica SE
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Rhinosinusitis
Keywords
BNO 1016, acute rhinosinusitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
386 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BNO 1016
Arm Type
Experimental
Arm 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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
sugar coated tablets with identical appearance to active treatment; frequency: 2 tablets t.i.d. duration: 15 days
Intervention Type
Drug
Intervention Name(s)
BNO 1016
Other Intervention Name(s)
Sinupret extract
Intervention 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
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo to BNO 1016
Intervention Description
sugar coated tablets with identical appearance to active treatment; frequency: 2 tablets t.i.d. duration 15 days
Primary Outcome Measure Information:
Title
Major Symptom Score (MSS) Assessed by the Investigator
Description
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.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
SNOT 20 Symptom Scores
Description
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
Time Frame
14 days
Title
Major Symptom Score Assessed by the Patient
Description
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.
Time Frame
14 days
Title
Percentage of Patients Classified as Responders by the Investigator on a 4-point Rating Scale
Description
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".
Time Frame
14 days
Title
Ultrasonography of Paranasal Sinuses
Description
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.
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rainer Jund, MD
Organizational Affiliation
Specialist in Otorhinolaryngology
Official's Role
Study Chair
Facility Information:
Facility Name
Dr. Rainer Jund, Specialist in Otorhinolaryngology
City
Puchheim
ZIP/Postal Code
82178
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
23193534
Citation
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.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of a Herbal Medicinal Product (Dry Extract BNO 1016) in Patients With Acute Rhinosinusitis
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