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

Chronic Sinusitis Clinical Trial

Official title: A Multicentre, Randomised, Double-blind, Placebo-controlled, Parallel Group Trial to Assess Efficacy and Safety of Two Dosages of a Herbal Medicinal Product (Dry Extract BNO 1016) in Patients With Chronic Rhinosinusitis

Status Completed

Clinical Trial 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.

Clinical Trial Description

The clinical trial population consists of patients presenting with two or more typical symptoms of CRS and duration of symptoms of at least ≥12 weeks. The diagnosis should have been confirmed with the initial diagnosis of CRS by nasal endoscopy and/or computer tomography (CT) and by obligatory nasal endoscopy including exclusion of nasal polyps during screening phase.

A total of 885 patients will be included in this clinical trial, which will last for approximately 12 months, including screening, treatment and medication-free follow-up period as well as final reporting. The duration for the individual patient is approximately 22 weeks (Visit 1 - Visit 7). After a 2-week screening phase, treatment will be started by application of either 240 mg or 480 mg daily dose (t.i.d.) or placebo for 12 weeks followed by a medication-free follow-up period.

Symptoms often do not correlate to the findings in nasal endoscopy or CT. Therefore, efficacy in this clinical trial is defined as per clinical definition using five individual rhinosinusitis symptoms (MSS)graded by the investigator using increasing severity grading(0 = absent [none / not present], 1 = mild, 2 = moderate, 3 = severe).

Secondary outcome measures include

• single rhinosinusitis symptoms of CRS (MSSINV and MSSPAT),

• Work Productivity and Activity Impairment patient questionnaire related to General Health [WPAI:GH],

• total symptom severity by Visual Analogue Scale

• response to treatment rated by investigator and patient

• 20-Question Sino-Nasal Outcome Test [SNOT-20, only Germany]

• percentage of patients with permitted concomitant medication for the treatment of CRS

• premature termination due to exacerbations of symptoms

• post treatment course of CRS will

• pharmacoeconomic assessments

• safety and tolerability of trial treatment ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Sinusitis

• NCT number: NCT01706484
• Study type: Interventional
• Source: Bionorica SE
• Status: Completed
• Phase: Phase 3
• Start date: September 2012
• Completion date: July 2014