Acute Rhinosinusitis
Conditions
Keywords
BNO 1016, acute rhinosinusitis
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.
Interventions
DRUGBNO 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
DRUGPlacebo
sugar coated tablets with identical appearance to active treatment; frequency: 2 tablets t.i.d. duration 15 days
Sponsors
Bionorica SE
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany
Participant flow
Recruitment details
January 2010 to April 2010 37 centres (16 ENT and 21 specialists in internal medicine and general practitioners
Participants by arm
| Arm | Count |
|---|---|
| BNO 1016 sugar coated tablets | 194 |
| Placebo sugar coated tablets | 192 |
| Total | 386 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | BNO 1016 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 20 Participants | 30 Participants |
| Age, Categorical Between 18 and 65 years | 182 Participants | 174 Participants | 356 Participants |
| Age Continuous | 40.4 years STANDARD_DEVIATION 14.3 | 41.0 years STANDARD_DEVIATION 15.4 | 40.7 years STANDARD_DEVIATION 14.9 |
| Region of Enrollment Germany | 192 participants | 194 participants | 386 participants |
| Sex: Female, Male Female | 122 Participants | 127 Participants | 249 Participants |
| Sex: Female, Male Male | 70 Participants | 67 Participants | 137 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 19 / 194 | 27 / 191 |
| serious Total, serious adverse events | 0 / 194 | 0 / 191 |
Outcome results
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.
Time frame: 14 days
Population: FAS: randomised patients with at least one documented application of the drug and post-baseline efficacy data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BNO 1016 | Major Symptom Score (MSS) Assessed by the Investigator | 2.38 units on a scale | Standard Error 0.18 |
| Placebo | Major Symptom Score (MSS) Assessed by the Investigator | 3.41 units on a scale | Standard Error 0.24 |
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.
Time frame: 14 days
Population: FAS: randomised patients with at least one documented application of the drug and post-baseline efficacy data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BNO 1016 | Major Symptom Score Assessed by the Patient | 2.62 units on a scale | Standard Error 0.21 |
| Placebo | Major Symptom Score Assessed by the Patient | 3.48 units on a scale | Standard Error 0.24 |
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.
Time frame: 14 days
Population: FAS: randomised patients with at least one documented application of the drug and post-baseline efficacy data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BNO 1016 | Percentage of Patients Classified as Responders by the Investigator on a 4-point Rating Scale | 94.2 percentage of patients |
| Placebo | Percentage of Patients Classified as Responders by the Investigator on a 4-point Rating Scale | 87.4 percentage of patients |
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
Time frame: 14 days
Population: FAS: randomised patients with at least one documented application of the drug and post-baseline efficacy data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BNO 1016 | SNOT 20 Symptom Scores | 11.02 units on a scale (range: 0 - 100) | Standard Deviation 12.72 |
| Placebo | SNOT 20 Symptom Scores | 15.76 units on a scale (range: 0 - 100) | Standard Deviation 16.26 |
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.
Time frame: 14 days
Population: FAS: randomised patients with at least one documented application of the drug and post-baseline efficacy data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BNO 1016 | Ultrasonography of Paranasal Sinuses | 26.8 percentage of patients |
| Placebo | Ultrasonography of Paranasal Sinuses | 38.4 percentage of patients |