Acute RhinosinusitisPhase 3NCT01146860
Efficacy and Safety of a Herbal Medicinal Product (Dry Extract BNO 1016) in Patients With Acute Rhinosinusitis
A Phase 3 study testing BNO 1016 in people with Acute Rhinosinusitis, run by Bionorica SE at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Rhinosinusitis
- What is being tested?
- BNO 1016
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 386 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to Apr 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dr. Rainer Jund, Specialist in Otorhinolaryngology
Puchheim, 82178
About this study
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
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.
Read the 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.
- Conditions
- Acute Rhinosinusitis
- Being tested
- BNO 1016, Placebo
- Keywords
- BNO 1016, acute rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNO 1016Drug
Also called Sinupret extract
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
PlaceboDrug
Also called Placebo to BNO 1016
sugar coated tablets with identical appearance to active treatment; frequency: 2 tablets t.i.d. duration 15 days
| Study group | Role | What they receive |
|---|---|---|
| BNO 1016 | Experimental | 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 Receives: Drug: BNO 1016 |
| Placebo | Placebo comparator | sugar coated tablets with identical appearance to active treatment; frequency: 2 tablets t.i.d. duration: 15 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Secondary outcomes (4)
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
Measured: 14 days
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.
Measured: 14 days
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".
Measured: 14 days
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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute RhinosinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 386 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bionorica SE
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rainer Jund, MD, Study chair, Specialist in Otorhinolaryngology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146860
- Sponsor's protocol ID
- ARhiSi-2
- Other IDs
- 2009-016682-28, 2009
- Status last verified
- Jun 2013
- First submitted
- 7 Jun 2010
- Last updated
- 2 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 23193534
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01146860
- Acronym / sponsor ID
- ARhiSi-2
- Conditions
- Acute Rhinosinusitis
- Keywords
- BNO 1016, acute rhinosinusitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- Bionorica SEIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Posted 2 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BNO 1016 | Experimental | Drug: BNO 1016sugar 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 comparator | Drug: Placebosugar coated tablets with identical appearance to active treatment; frequency: 2 tablets t.i.d. duration: 15 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BNO 1016Also: Sinupret extractsugar coated tablets with dry extract (80 mg) of 5 herbal drugs; dosage: 480 mg per day (2 tablets t.i.d.) duration: 15 days | Drug | BNO 1016 |
| PlaceboAlso: Placebo to BNO 1016sugar coated tablets with identical appearance to active treatment; frequency: 2 tablets t.i.d. duration 15 days | Drug | Placebo |
Primary outcome
Major Symptom Score (MSS) Assessed by the Investigator
Time frame: 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.
4 secondary outcomes
SNOT 20 Symptom Scores
Time frame: 14 days
Major Symptom Score Assessed by the Patient
Time frame: 14 days
Percentage of Patients Classified as Responders by the Investigator on a 4-point Rating Scale
Time frame: 14 days
Ultrasonography of Paranasal Sinuses
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23193534Jund 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rainer Jund, MD study chair
Specialist in Otorhinolaryngology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BNO 1016 in people with Acute Rhinosinusitis, run by Bionorica SE at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Symptom Score (MSS) Assessed by the Investigator (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01146860, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2013.