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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
  Purpose
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.

Condition Intervention Phase
Acute Rhinosinusitis
Drug: BNO 1016
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by Bionorica SE:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • SNOT 20 Symptom Scores [ Time Frame: 14 days ]

    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 ]

    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 ]
    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 ]
    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.


Enrollment: 386
Study Start Date: January 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Placebo Comparator: Placebo
sugar coated tablets with identical appearance to active treatment; frequency: 2 tablets t.i.d. duration: 15 days
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

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

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01146860

Locations
Germany
Dr. Rainer Jund, Specialist in Otorhinolaryngology
Puchheim, Germany, 82178
Sponsors and Collaborators
Bionorica SE
Investigators
Study Chair: Rainer Jund, MD Specialist in Otorhinolaryngology
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bionorica SE
ClinicalTrials.gov Identifier: NCT01146860     History of Changes
Other Study ID Numbers: ARhiSi-2
2009-016682-28 ( EudraCT Number )
Study First Received: June 7, 2010
Results First Received: October 9, 2012
Last Updated: June 28, 2013

Keywords provided by Bionorica SE:
BNO 1016, acute rhinosinusitis

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 23, 2017