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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
927
comparison of different dosages of drug and placebo
Claus Bachert, Prof. Dr.
Ghent, Belgium
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).
Time frame: 4 weeks
Patient´s MSS ratings [score points] from V5 to V6
Arithmetic mean of approximately 28 ratings, Diary data
Time frame: 4 weeks
Investigtor´s MSS ratings [score points] at V3
CRF data
Time frame: Day 8
Investigator´s MSS ratings [score points] at V4
CRF data
Time frame: Day 29
Investigtor´s MSS ratings [score points] at V5
CRF data
Time frame: Day 57
Investigtor´s MSS ratings [score points] at V6
CRF data
Time frame: Day 85
Investigtor´s MSS ratings [score points] at V7
CRF data
Time frame: Day 141
Responders based on investigators´ ratings at V2, V3, V4, V5, V6 and V7
Time frame: 20 weeks
Responders based on patients´ ratings at V2, V3, V4, V5, V6 and V7
Time frame: 20 weeks
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