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NCT Number: NCT01146860

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.

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Key information

Conditions

Acute Rhinosinusitis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dr. Rainer Jund, Specialist in Otorhinolaryngology

Puchheim, 82178, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BNO 1016

Drug

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 names: Sinupret extract

Placebo

Drug

sugar coated tablets with identical appearance to active treatment; frequency: 2 tablets t.i.d. duration 15 days

Other names: Placebo to BNO 1016

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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.

  3. 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".

  4. 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.

Sponsors and collaborators

Lead sponsor

Bionorica SE

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 22, 2010
Registry last updated
Aug 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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