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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bionorica SE
ClinicalTrials.gov Identifier:
NCT01146860
First received: June 7, 2010
Last updated: June 28, 2013
Last verified: June 2013

June 7, 2010
June 28, 2013
January 2010
April 2010   (final data collection date for primary outcome measure)
Major Symptom Score (MSS) Assessed by the Investigator [ Time Frame: 14 days ] [ Designated as safety issue: No ]

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.

Same as current
Complete list of historical versions of study NCT01146860 on ClinicalTrials.gov Archive Site
  • SNOT 20 Symptom Scores [ Time Frame: 14 days ] [ Designated as safety issue: No ]

    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

  • Major Symptom Score Assessed by the Patient [ Time Frame: 14 days ] [ Designated as safety issue: No ]

    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.

  • Percentage of Patients Classified as Responders by the Investigator on a 4-point Rating Scale [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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".
  • Ultrasonography of Paranasal Sinuses [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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.
  • SNOT 20 symptom scores [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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.
  • Major Symptom Score assessed by the patient [ Time Frame: 14 days ] [ Designated as safety issue: No ]

    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.

  • Percentage of patients classified as responders by the investigator on a 4-point rating scale [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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.
  • Percentage of patients with signs of acute rhinosinusitis in ultrasonography of paranasal sinuses [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Ultrasonography scans will be visually evaluated by the investigator for signs of rhinosinusitis.
Not Provided
Not Provided
 
Efficacy and Safety of a Herbal Medicinal Product (Dry Extract BNO 1016) in Patients With Acute Rhinosinusitis
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Acute Rhinosinusitis
  • Drug: BNO 1016
    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
    Other Name: Sinupret extract
  • Drug: Placebo
    sugar coated tablets with identical appearance to active treatment; frequency: 2 tablets t.i.d. duration 15 days
    Other Name: Placebo to BNO 1016
  • Experimental: BNO 1016
    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
    Intervention: Drug: BNO 1016
  • Placebo Comparator: Placebo
    sugar coated tablets with identical appearance to active treatment; frequency: 2 tablets t.i.d. duration: 15 days
    Intervention: Drug: Placebo
Jund R, Mondliger 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/Rhin.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
386
April 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01146860
ARhiSi-2, 2009-016682-28
No
Bionorica SE
Bionorica SE
Not Provided
Study Chair: Rainer Jund, MD Specialist in Otorhinolaryngology
Bionorica SE
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP