Phase 3
Completed N=386
Efficacy and Safety of a Herbal Medicinal Product (Dry Extract BNO 1016) in Patients With Acute Rhinosinusitis
Source: ClinicalTrials.gov NCT01146860 ↗Enrolled (actual)
386
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcomePrimary: Major Symptom Score (MSS) Assessed by the Investigator — 2.38; 3.41 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Major Symptom Score (MSS) Assessed by the Investigator |
2.38; 3.41 | — |
| SECONDARY SNOT 20 Symptom Scores |
11.02; 15.76 | — |
| SECONDARY Major Symptom Score Assessed by the Patient |
2.62; 3.48 | — |
| SECONDARY Percentage of Patients Classified as Responders by the Investigator on a 4-point Rating Scale |
94.2; 87.4 | — |
| SECONDARY Ultrasonography of Paranasal Sinuses |
26.8; 38.4 | — |
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
Data sourced from ClinicalTrials.gov (NCT01146860). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.