Efficacy and Safety of Two Dosages of a Herbal Medicinal Product (Dry Extract BNO 1016) in Chronic Rhinosinusitis

NCT01706484 | Completed Phase 3

• 2 other identifiers: CRS-022011-003623-35
• Study Type: interventional
• Target: 927
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to determine whether 2 different dosages of a herbal extract (240 and 480 mg/day) are more effective than placebo in the treatment of patients with chronic rhinosinusitis (average reduction of investigator's Major Symptom Score over Visit 5 and Visit 6.

Conditions

Chronic Sinusitis

Keywords

randomized clinical trial; chronic rhinosinusitis; herbal extract BNO 1016; exacerbation; pharmacoeconomic; quality of life

Outcome Measures

Primary Outcomes (1)

• Average of investigator's Major Symptom Score ratings [score points] at V5 and V6

  The primary efficacy endpoint is defined as the average of investigator's Major Symptom Score ratings \[score points\] at V5 and V6 (arithmetic mean of 2 ratings).

  4 weeks

Secondary Outcomes (8)

• Patient´s MSS ratings [score points] from V5 to V6

  4 weeks

• Investigtor´s MSS ratings [score points] at V3

  Day 8

• Investigator´s MSS ratings [score points] at V4

  Day 29

• Investigtor´s MSS ratings [score points] at V5

  Day 57

• Investigtor´s MSS ratings [score points] at V6

  Day 85

Other Outcomes (1)

• CRS-related absenteeism from work

  20 weeks

Study Arms (3)

80 mg BNO 1016 und placebo

EXPERIMENTAL

2 tablets (one containing 80 mg BNO 1016 and one placebo) by mouth 3 times daily

Drug: BNO 1016

160 mg BNO 1016

EXPERIMENTAL

2 tablets (each containing 80 mg BNO 1016) by mouth 3 times daily

Drug: BNO 1016

placebo

PLACEBO COMPARATOR

2 tablets (each without BNO 1016) by mouth 3 times daily

Drug: BNO 1016

Interventions

BNO 1016 DRUG

comparison of different dosages of drug and placebo

Also known as: herbal plant extract,, sinupret extract mite

160 mg BNO 1016; 80 mg BNO 1016 und placebo; placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent including data protection declaration
• Male and female outpatients aged ≥18 and ≤75 years
• Diagnosis of bilateral chronic rhinosinusitis without nasal polyps confirmed by:
• nasal endoscopy during the screening period (nasal endoscopy results not older than 2 month will be accepted) to confirm inflammation, mucopurulent discharge and/or oedema/mucosal obstruction primarily in middle meatus without nasal polyps being present
• at the discretion of the investigator a historic CT (before screening and not older than 24 months) will be considered additionally for confirmation of bilateral involvement of middle meatus and paranasal sinuses without resolution of symptoms (mucosal changes within the ostiomeatal complex and/or sinuses)
• Bilateral chronic rhinosinusitis characterized by (V1 and V2):
• presence of chronic rhinosinusitis symptoms for at least 12 weeks without complete resolution of symptoms prior to enrolment (V1)
• a MSS ≥6 points and ≤12 points for each of the screening days observed by diary entries (MSSPAT)and on the days of Visit 1 and 2 (MSSINV)
• on 5 random days of the screening period (or at least at days -5 to -1) assessed by MSSPAT and on the day of Visit 1 and 2 assessed by MSSINV: rhinorrhoea (anterior or posterior) and pain (facial pain or headache) of at least moderate intensity (score ≥2).

You may not qualify if:

• Sinus surgery within the last 2 years (solitary sinus puncture is allowed)
• Nasal concha surgery within the last 3 months
• Presence or history of uni- or bilateral nasal polyps
• Presence of moderate to severe co-morbid asthma, including allergic asthma
• Patients with cystic fibrosis
• Patients with a positive skin prick test at V1 against allergens to which the patient might be exposed to during the expected individual trial duration, if clinically relevant (results not older than 12 months will be accepted)
• Clinically relevant perennial (e.g. patients with actual clinical symptoms of allergic rhinitis against house dust/-mite antigen) or actual seasonal allergic rhinitis
• Rhinitis medicamentosa (drug induced rhinitis)
• Aspirin-Exacerbated Respiratory Disease \[AERD\] (Aspirin sensitivity)
• Dentogenic sinusitis or otherwise unilateral sinusitis
• Presence of anatomical deviations of the nasal septum that significantly impair nasal and paranasal ventilation / airflow
• Known hypersensitivity to trial medication or excipients
• Patients with rare hereditary problems of fructose intolerance, galactose intolerance, lactase deficiency or glucose-galactose malabsorption or sucrase-isomaltase insufficiency
• Signs or symptoms of acute bacterial sinusitis (e.g. fever \> 38.5°C, orbital complications,severe unilateral frontal headache or toothache)
• Treatment with systemic or nasal antibiotics or corticosteroids within the last 4 weeks prior to V1

Sponsors & Collaborators

• Bionorica SE: lead

Study Sites (1)

Claus Bachert, Prof. Dr.

Ghent, Belgium

Location

MeSH Terms

Interventions

BNO 1016; Plant Extracts

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Pharmaceutical Preparations

Study Officials

• Claus Bachert, Prof. Dr.

  Ghent University Hospital; Ear, Nose, Throat Medicine, Head & Neck Surgery; Upper Airway Research Laboratory - UZ Gent; De Pintelaan 185 / 1P1; 9000 Gent; Belgium.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2012
• First Posted: October 15, 2012
• Study Start: September 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 8, 2014

Record last verified: 2014-07

Locations

BE (1)