Clinical trial NCT01146860: Efficacy and Safety of a Herbal Medicinal Product (Dry Extract BNO 1016) in Patients With Acute Rhinosinusitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Rhinosinusitis
Keywords: BNO 1016, acute rhinosinusitis
Lead sponsor: Bionorica SE
Sponsor class: INDUSTRY
First posted: 2010-06-22
Enrollment: 386
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Major Symptom Score (MSS) Assessed by the Investigator
timeFrame: 14 days
Secondary outcomes:
measure: SNOT 20 Symptom Scores
timeFrame: 14 days
measure: Major Symptom Score Assessed by the Patient
timeFrame: 14 days
measure: Percentage of Patients Classified as Responders by the Investigator on a 4-point Rating Scale
timeFrame: 14 days
measure: Ultrasonography of Paranasal Sinuses
timeFrame: 14 days
Other outcomes:
Locations:
city: Puchheim
country: Germany
facility: Dr. Rainer Jund, Specialist in Otorhinolaryngology
Study officials:
affiliation: Specialist in Otorhinolaryngology
name: Rainer Jund, MD
role: STUDY_CHAIR
References:
citation: 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.