Trial Outcomes & Findings for Efficacy and Safety of a Herbal Medicinal Product (Dry Extract BNO 1016) in Patients With Acute Rhinosinusitis (NCT NCT01146860)
NCT ID: NCT01146860
Last Updated: 2013-08-02
Results Overview
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.
COMPLETED
PHASE3
386 participants
14 days
2013-08-02
Participant Flow
January 2010 to April 2010 37 centres (16 ENT and 21 specialists in internal medicine and general practitioners
Participant milestones
| Measure |
BNO 1016
sugar coated tablets with dry extract (80 mg) of 5 herbal drugs; daily dose: 480 mg (2 tablets tid)
|
Placebo
sugar coated tablets of identical appearance to active treatment
|
|---|---|---|
|
Overall Study
STARTED
|
194
|
192
|
|
Overall Study
COMPLETED
|
194
|
191
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
BNO 1016
sugar coated tablets with dry extract (80 mg) of 5 herbal drugs; daily dose: 480 mg (2 tablets tid)
|
Placebo
sugar coated tablets of identical appearance to active treatment
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of a Herbal Medicinal Product (Dry Extract BNO 1016) in Patients With Acute Rhinosinusitis
Baseline characteristics by cohort
| Measure |
BNO 1016
n=194 Participants
sugar coated tablets
|
Placebo
n=192 Participants
sugar coated tablets
|
Total
n=386 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
174 Participants
n=5 Participants
|
182 Participants
n=7 Participants
|
356 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age Continuous
|
41.0 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
40.4 years
STANDARD_DEVIATION 14.3 • n=7 Participants
|
40.7 years
STANDARD_DEVIATION 14.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
127 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
249 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
194 participants
n=5 Participants
|
192 participants
n=7 Participants
|
386 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: FAS: randomised patients with at least one documented application of the drug and post-baseline efficacy data
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.
Outcome measures
| Measure |
BNO 1016
n=190 Participants
sugar coated tablets
|
Placebo
n=190 Participants
sugar coated tablets
|
|---|---|---|
|
Major Symptom Score (MSS) Assessed by the Investigator
|
2.38 units on a scale
Standard Error 0.18
|
3.41 units on a scale
Standard Error 0.24
|
SECONDARY outcome
Timeframe: 14 daysPopulation: FAS: randomised patients with at least one documented application of the drug and post-baseline efficacy data
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
Outcome measures
| Measure |
BNO 1016
n=190 Participants
sugar coated tablets
|
Placebo
n=190 Participants
sugar coated tablets
|
|---|---|---|
|
SNOT 20 Symptom Scores
|
11.02 units on a scale (range: 0 - 100)
Standard Deviation 12.72
|
15.76 units on a scale (range: 0 - 100)
Standard Deviation 16.26
|
SECONDARY outcome
Timeframe: 14 daysPopulation: FAS: randomised patients with at least one documented application of the drug and post-baseline efficacy data
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.
Outcome measures
| Measure |
BNO 1016
n=190 Participants
sugar coated tablets
|
Placebo
n=190 Participants
sugar coated tablets
|
|---|---|---|
|
Major Symptom Score Assessed by the Patient
|
2.62 units on a scale
Standard Error 0.21
|
3.48 units on a scale
Standard Error 0.24
|
SECONDARY outcome
Timeframe: 14 daysPopulation: FAS: randomised patients with at least one documented application of the drug and post-baseline efficacy data
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".
Outcome measures
| Measure |
BNO 1016
n=190 Participants
sugar coated tablets
|
Placebo
n=190 Participants
sugar coated tablets
|
|---|---|---|
|
Percentage of Patients Classified as Responders by the Investigator on a 4-point Rating Scale
|
94.2 percentage of patients
|
87.4 percentage of patients
|
SECONDARY outcome
Timeframe: 14 daysPopulation: FAS: randomised patients with at least one documented application of the drug and post-baseline efficacy data
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.
Outcome measures
| Measure |
BNO 1016
n=190 Participants
sugar coated tablets
|
Placebo
n=190 Participants
sugar coated tablets
|
|---|---|---|
|
Ultrasonography of Paranasal Sinuses
|
26.8 percentage of patients
|
38.4 percentage of patients
|
Adverse Events
BNO 1016
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BNO 1016
n=194 participants at risk
sugar coated tablets
|
Placebo
n=191 participants at risk
sugar coated tablets
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/194
|
0.52%
1/191 • Number of events 1
|
|
Ear and labyrinth disorders
Cerumen impaction
|
1.0%
2/194 • Number of events 2
|
0.00%
0/191
|
|
Ear and labyrinth disorders
Ear pain
|
0.52%
1/194 • Number of events 1
|
0.00%
0/191
|
|
Ear and labyrinth disorders
Tinnitus
|
0.52%
1/194 • Number of events 1
|
0.00%
0/191
|
|
Eye disorders
Eye discharge
|
0.00%
0/194
|
0.52%
1/191 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/194
|
0.52%
1/191 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal upper pain
|
0.00%
0/194
|
0.52%
1/191 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
1.0%
2/194 • Number of events 2
|
1.6%
3/191 • Number of events 3
|
|
Gastrointestinal disorders
Flatulence
|
0.52%
1/194 • Number of events 1
|
0.00%
0/191
|
|
Gastrointestinal disorders
Nausea
|
0.52%
1/194 • Number of events 1
|
0.00%
0/191
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/194
|
1.6%
3/191 • Number of events 3
|
|
General disorders
Facial pain
|
0.00%
0/194
|
0.52%
1/191 • Number of events 1
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/194
|
0.52%
1/191 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/194
|
1.0%
2/191 • Number of events 2
|
|
Infections and infestations
Bronchitis
|
0.00%
0/194
|
0.52%
1/191 • Number of events 1
|
|
Infections and infestations
Furuncle
|
0.52%
1/194 • Number of events 1
|
0.00%
0/191
|
|
Infections and infestations
Gastroenteritis
|
1.5%
3/194 • Number of events 3
|
1.0%
2/191 • Number of events 2
|
|
Infections and infestations
Laryngitis
|
0.52%
1/194 • Number of events 1
|
0.00%
0/191
|
|
Infections and infestations
Viral infection
|
0.00%
0/194
|
0.52%
1/191 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/194
|
0.52%
1/191 • Number of events 1
|
|
Injury, poisoning and procedural complications
Injury
|
0.52%
1/194 • Number of events 1
|
0.52%
1/191 • Number of events 1
|
|
Investigations
ASAT increased
|
0.00%
0/194
|
0.52%
1/191 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.52%
1/194 • Number of events 1
|
0.00%
0/191
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.52%
1/194 • Number of events 1
|
1.0%
2/191 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
1.0%
2/194 • Number of events 2
|
0.52%
1/191 • Number of events 1
|
|
Psychiatric disorders
Depressed mood
|
0.52%
1/194 • Number of events 1
|
0.52%
1/191 • Number of events 1
|
|
Reproductive system and breast disorders
Genital discharge
|
0.00%
0/194
|
0.52%
1/191 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/194
|
0.52%
1/191 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/194
|
0.52%
1/191 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/194
|
0.52%
1/191 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/194
|
0.52%
1/191 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Ingrown hair
|
0.00%
0/194
|
0.52%
1/191 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.52%
1/194 • Number of events 1
|
0.00%
0/191
|
|
Surgical and medical procedures
Surgery
|
0.52%
1/194 • Number of events 1
|
0.00%
0/191
|
Additional Information
Dr. Rainer Jund, Specialist in Otorhinolaryngology
ENT practice
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place