Phase 3 N=386 Randomized Double-blind Treatment

Efficacy and Safety of a Herbal Medicinal Product (Dry Extract BNO 1016) in Patients With Acute Rhinosinusitis

Acute Rhinosinusitis

Bottom Line

View on ClinicalTrials.gov: NCT01146860 ↗

Enrolled (actual)

386

Serious AEs

0.0%

Results posted

Aug 2013

Primary outcome: Primary: Major Symptom Score (MSS) Assessed by the Investigator — 2.38; 3.41 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: BNO 1016 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bionorica SE
Primary completion: Apr 2010

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	—

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.

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

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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.