- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02746042
Sinupret Extract Coated Tablets in Chronic Rhinosinusitis
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Assess Efficacy and Safety of the Herbal Medicinal Product Sinupret Extract Coated Tablets in Patients With Chronic Rhinosinusitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Berlin, Germany, 13353
- Bionorica Investigative Site
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Braunschweig, Germany
- Bionorica Investigative Site
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Chemnitz, Germany
- Bionorica Investigative Site
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Dresden, Germany, 01067
- Bionorica Investigative Site
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Dresden, Germany, 01139
- Bionorica Investigative Site
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Dresden, Germany, 01159
- Bionorica Investigative Site
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Dresden, Germany, 01307
- Bionorica Investigative Site
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Duisburg, Germany
- Bionorica Investigative Site
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Essen, Germany
- Bionorica Investigative Site
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Frankfurt am Main, Germany
- Bionorica Investigative Site
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Goettingen, Germany
- Bionorica Investigative Site
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Heidelberg, Germany, 69120
- Bionorica Investigative Site
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Heidelberg, Germany, 69126
- Bionorica Investigative Site
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Markkleeberg, Germany
- Bionorica Investigative Site
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Mittweida, Germany
- Bionorica Investigative Site
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Munich, Germany, 80331
- Bionorica Investigative Site
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Neuenhagen, Germany
- Bionorica Investigative Site
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Nuremberg, Germany
- Bionorica Investigative Site
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Röthenbach/Pegnitz, Germany
- Bionorica Investigative Site
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Schluchtern, Germany
- Bionorica Investigative Site
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Schorndorf, Germany
- Bionorica Investigative Site
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Wuppertal, Germany
- Bionorica Investigative Site
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Bialystok, Poland, 15-270
- Bionorica Investigative Site
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Bialystok, Poland, 15-879
- Bionorica Investigative Site
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Bydgoszcz, Poland
- Bionorica Investigative Site
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Gdansk, Poland
- Bionorica Investigative Site
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Gdynia, Poland
- Bionorica Investigative Site
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Katowice, Poland, 40-036
- Bionorica Investigative Site
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Katowice, Poland, 40-611
- Bionorica Investigative Site
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Katowice, Poland, 40-954
- Bionorica Investigative Site
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Kielce, Poland
- Bionorica Investigative Site
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Krakow, Poland, 30-349
- Bionorica Investigative Site
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Krakow, Poland, 30-548
- Bionorica Investigative Site
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Krakow, Poland, 31-624
- Bionorica Investigative Site
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Limanowa, Poland
- Bionorica Investigative Site
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Lodz, Poland
- Bionorica Investigative Site
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Lublin, Poland, 20-552
- Bionorica Investigative Site
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Piaseczno, Poland
- Bionorica Investigative Site
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Szczecin, Poland
- Bionorica Investigative Site
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Tychy, Poland
- Bionorica Investigative Site
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Warszawa, Poland, 01-868
- Bionorica Investigative Site
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Wieliczka, Poland
- Bionorica Investigative Site
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Wroclaw, Poland
- Bionorica Investigative Site
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Zgierz, Poland
- Bionorica Investigative Site 222
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Zgierz, Poland
- Bionorica Investigative Site 224
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Signed informed consent (IC) including data protection declaration
Male and female outpatients aged ≥18 and ≤75 years
Women will be considered for inclusion if they are not pregnant (as confirmed by urine pregnancy test at V1 and V2), not breastfeeding, or if they are surgically sterile (have had a documented bilateral oophorectomy and/or hysterectomy) or if menopause is ensured (at least 12 months without menstrual bleeding). Women of childbearing potential must use a highly effective (failure rate less than 1% per year, i.e. Pearl Index <1) method of contraception 2 weeks prior to trial inclusion and during the screening/treatment period of the clinical trial (e.g. vasectomized partner, sexual abstinence - the lifestyle of the female has to be such that there is complete abstinence from intercourse from 2 weeks prior to the first dose of trial medication until at least 72 hours after treatment - implants, injectables, combined oral contraceptives, or hormonal intrauterine devices).
Diagnosis of bilateral CRS without nasal polyps confirmed by:
- Nasal endoscopy during the screening phase to confirm inflammation, mucopurulent discharge, and/or edema/mucosal obstruction primarily in middle meatus without nasal polyps being present
- At the discretion of the investigator, results from a historic imaging diagnostic, i.e. computer tomography (CT), digital volume tomography (DVT), or magnetic resonance tomography (MRT) (before screening and not older than 24 months, not taken during acute exacerbation), which 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 CRS characterized by:
- Presence of CRS symptoms for >52 weeks prior to enrolment (V1) as documented in the medical file of the patient
- Major Symptom Score (MSS) ≥10 at V1 and V2 as assessed by the investigator (MSS INV), and rhinorrhea (anterior or posterior) and pain (facial pain or headache) each of at least moderate intensity (score ≥2)
Exclusion Criteria:
- Sinus surgery within the last 2 years (solitary sinus puncture is allowed)
- Inferior turbinate reduction (by surgery or other methods) within the last 3 months
- Presence or history of uni- or bilateral nasal polyps
- Moderate to severe co-morbid asthma, including allergic asthma
- Cystic fibrosis
- Perennial (e.g. patients with clinical symptoms of allergic rhinitis against house dust/mite antigen) or seasonal allergic rhinitis
- Rhinitis medicamentosa (drug induced rhinitis)
- Aspirin-exacerbated respiratory disease (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
- Rare hereditary problems of fructose intolerance, galactose intolerance, lactase deficiency, 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 antihistamines within 4 weeks prior to V1
- Treatment with 2-3.5% hypertonic saline solution within 2 weeks prior to V1
- Treatment with systemic or nasal antibiotics or corticosteroids within 4 weeks prior to V1
- Treatment with decongestant preparations (α-sympathomimetics), analgesics (including systemic non-steroidal inflammatory drugs [NSAIDs], including paracetamol), mucolytics/secretolytics, or alternative medicine preparations for treatment of common cold-like symptoms or with immunomodulating properties within 7 days prior to V1
- Peptic ulcer
- Gastritis
- Other diseases within 5 years prior to V1 that, in the opinion of the investigator, disqualifies the patient for trial enrolment (e.g. liver or kidney disease, severe somatopathic, neurological and/or psychiatric diseases, history of malignancy, alcohol or drug abuse, or immunodeficiency)
- Parallel participation in another clinical trial, participation in a different trial within less than 6 weeks prior to trial entry, or previous randomization into this clinical trial
- Known to be, or suspected of being unable to comply with the clinical trial protocol (CTP) that in the opinion of the investigator disqualifies the patient for trial enrolment (e.g. no permanent address, known to be non-compliant, or presenting an unstable psychiatric history)
- Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope, and possible impact of the clinical trial
- Patients in custody by juridical or official order
- Patients who have difficulties in understanding the local language in which the patient information (PI) is given
- Patients who are members of the staff of the investigational site, staff of the sponsor or involved CRO, the investigator him/herself or close relatives
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sinupret extract coated tablets
Sinupret extract coated tablets: one tablet three times a day orally during the 16-week treatment phase. There will be no dose change during the trial. |
1 coated tablet 3 times a day for 16-weeks (1-1-1)
Other Names:
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Placebo Comparator: Placebo coated tablets
Placebo coated tablets: One tablet three times a day orally during the 16-week treatment Phase.
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1 coated tablet 3 times a day for 16-weeks (1-1-1)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MSS-INV at V7
Time Frame: 16 weeks
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Major Symptom Score (MSS) assessed by the investigator at Visit 7 with Baseline as Covariate; The MSS considers: rhinorrhea [anterior], rhinorrhea [posterior], nasal congestion, headache, and facial pain/pressure
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16 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MSS-INV at V4-6
Time Frame: 12 weeks
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Major Symptom Score (MSS) assessed by the investigator at Visits 4, 5, and 6 with Baseline as Covariate
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12 weeks
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MSS-PAT at V4-7
Time Frame: 16 weeks
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Major Symptom Score (MSS) assessed by the Patient at Visits 4, 5, 6, and 7 with Baseline as Covariate
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16 weeks
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Minimal MSS-INV at V4-7
Time Frame: 16 weeks
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Minimal Major Symptom Score (MSS) assessed by the Investigator of all visits from Visits 4, 5, 6, and 7
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16 weeks
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Minimal MSS-PAT at V4-7
Time Frame: 16 weeks
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Minimal Major Symptom Score (MSS) assessed by the Patient of all visits from Visits 4, 5, 6, and 7
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16 weeks
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Investigator's Ratings of CRS symptom
Time Frame: 16 weeks
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Investigator's ratings of each individual CRS symptom (i.e.
rhinorrhea [anterior], rhinorrhea [posterior], nasal congestion, headache, and facial pain/pressure) at V4, V5, V6, and V7
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16 weeks
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Patient's Ratings of CRS symptom
Time Frame: 16 weeks
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Patient's ratings of each individual CRS symptom (i.e.
rhinorrhea [anterior], rhinorrhea [posterior], nasal congestion, headache, and facial pain/pressure) at V4, V5, V6, and V7
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16 weeks
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SNOT-22
Time Frame: 16 weeks
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22-Item Sino-Nasal Outcome Test (SNOT-22)Total Score as well as SNOT-22 primary nasal score (SNOT-22 PNS) and SNOT-22 general quality of life score (SNOT-22 ALQ) at V4, V5, V6, and V7
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16 weeks
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VAS
Time Frame: 16 weeks
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Total symptom severity assessed by the patient on a visual analogue scale (VAS) at V4, V5, V6, and V7
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16 weeks
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Responder Rate
Time Frame: 16 weeks
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Proportion of patients whose MSS-INV and MSS-PAT improved by ≥30%, ≥40%, ≥50%, ≥60% and ≥70% at V4, V5, V6, and V7.
Responders are defined as patients who show at least an MSS improvement of ≥30%
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16 weeks
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Concomitant drug and non-drug therapy
Time Frame: 22 weeks
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Patients with permitted concomitant drug and non-drug therapy (i.e.
isotonic saline solution as nasal spray, nasal irrigation [nasal lavage], or ultrasonic nebulizer) for CRS
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22 weeks
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Premature Terminations
Time Frame: 20 weeks
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Number of patients with premature termination due to exacerbation of CRS symptoms
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20 weeks
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Investigator's and patient's overall assessment of efficacy (questionnaire)
Time Frame: 16 weeks
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At each on-site visit during the treatment phase (V4 to V7), both the investigator and the patient have to provide an overall assessment of treatment efficacy using 5 categories ("very good", "good", "moderate", "poor", and "very poor"; ranges from 0 to 4).
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16 weeks
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WPAI:GH questionnaire
Time Frame: 22 weeks
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Pharmacoeconomic evaluation (utilization of health care resources) based on "Work Productivity and Activity Impairment, Global Health" (WPAI:GH) questionnaire completed by the patient at V4, V5, V6, and V7
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22 weeks
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Inflammatory Parameter IL-1beta (nasal secretions: substudy)
Time Frame: 16 weeks
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Absolute concentrations and total amount per sample of interleukin-1β (IL-1beta) in nasal secretions collected at V2, V5, and V7 for a subset of approximately 60 patients in selected investigational sites in Germany
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16 weeks
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Inflammatory Parameter IL-2 (nasal secretions: substudy)
Time Frame: 16 weeks
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Absolute concentrations and total amount per sample of interleukin-2 (IL-2) in nasal secretions collected at V2, V5, and V7 for a subset of approximately 60 patients in selected investigational sites in Germany
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16 weeks
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Inflammatory Parameter IL-4 (nasal secretions: substudy)
Time Frame: 16 weeks
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Absolute concentrations and total amount per sample of interleukin-4 (IL-4) in nasal secretions collected at V2, V5, and V7 for a subset of approximately 60 patients in selected investigational sites in Germany
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16 weeks
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Inflammatory Parameter IL-6 (nasal secretions: substudy)
Time Frame: 16 weeks
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Absolute concentrations and total amount per sample of interleukin-6 (IL-6) in nasal secretions collected at V2, V5, and V7 for a subset of approximately 60 patients in selected investigational sites in Germany
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16 weeks
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Inflammatory Parameter IL-8 (nasal secretions: substudy)
Time Frame: 16 weeks
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Absolute concentrations and total amount per sample of interleukin-8 (IL-8) in nasal secretions collected at V2, V5, and V7 for a subset of approximately 60 patients in selected investigational sites in Germany
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16 weeks
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Inflammatory Parameter IFN-gamma (nasal secretions: substudy)
Time Frame: 16 weeks
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Absolute concentrations and total amount per sample of interferon gamma (IFN-gamma) in nasal secretions collected at V2, V5, and V7 for a subset of approximately 60 patients in selected investigational sites in Germany
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16 weeks
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Inflammatory Parameter TNF-alpha (nasal secretions: substudy)
Time Frame: 16 weeks
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Absolute concentrations and total amount per sample of tumor necrosis factor alpha (TNF-alpha) in nasal secretions collected at V2, V5, and V7 for a subset of approximately 60 patients in selected investigational sites in Germany
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16 weeks
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Inflammatory Parameter MPO (nasal secretions: substudy)
Time Frame: 16 weeks
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Absolute concentrations and total amount per sample of myeloperoxidase (MPO) in nasal secretions collected at V2, V5, and V7 for a subset of approximately 60 patients in selected investigational sites in Germany
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16 weeks
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Inflammatory Parameter ECP (nasal secretions: substudy)
Time Frame: 16 weeks
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Absolute concentrations and total amount per sample of eosinophil cationic protein (ECP) in nasal secretions collected at V2, V5, and V7 for a subset of approximately 60 patients in selected investigational sites in Germany
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16 weeks
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Inflammatory Parameter alpha-2-macroglobulin (nasal secretions: substudy)
Time Frame: 16 weeks
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Absolute concentrations and total amount per sample of α2-macroglobulin (alpha-2-macroglobulin) in nasal secretions collected at V2, V5, and V7 for a subset of approximately 60 patients in selected investigational sites in Germany
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16 weeks
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Inflammatory Parameter HMGB-1 (nasal secretions: substudy)
Time Frame: 16 weeks
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Absolute concentrations and total amount per sample of high-mobility group box protein 1 (HMGB-1) in nasal secretions collected at V2, V5, and V7 for a subset of approximately 60 patients in selected investigational sites in Germany
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16 weeks
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Inflammatory Parameter albumin (nasal secretions: substudy)
Time Frame: 16 weeks
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Absolute concentrations and total amount per sample of albumin in nasal secretions collected at V2, V5, and V7 for a subset of approximately 60 patients in selected investigational sites in Germany
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16 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety Endpoints
Time Frame: 22 weeks
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The safety endpoints include:
|
22 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jürgen Palm, Dr., Praxis Dr. Jürgen Palm, 90552 Röthenbach/Pegnitz, Germany
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRS-03
- 2015-001952-31 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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