Chronic Rhinosinusitis
Conditions
Interventions
Product Name: Dry extract BNO-1016 Coated Tablets
Product Code: BNO-1016
Pharmaceutical Form: Coated tablet
CAS Number: 8000040-68-8
Other descriptive name: PRIMULA FLOWERS
Concentration unit: U unit(
Sponsors
Bionorica SE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Signed informed consent including data protection declaration 2.Male and femaleA) outpatients aged =18 and =75 years 3.Diagnosis of bilateral chronic rhinosinusitis without nasal polyps confirmed by: -nasal endoscopy during the screening period (nasal endoscopy results not older than 2 months will be accepted) -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 4.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 -a MSS =6 points and =12 points for each of the screening days observed by diary entries and at the day of Visit 2 -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 2 assessed by MSSINV: rhinorrhoea (anterior or posterior) and pain (facial pain or headache) of at least moderate intensity (score =2) A)Women will be considered for inclusion if they are not pregnant (as confirmed by urine pregnancy test), and not breastfeading. Women of childbearing potential must use a highly effective (failure rate less than 1% per year, i.e. Pearl Index =65 years) yes F.1.3.1 Number of subjects for this age range 77
Exclusion criteria
Exclusion criteria: Medical history and medications: 1.Sinus surgery within the last 5 years (solitary sinus puncture is allowed) 2.Presence of uni-or bilateral nasal polyps 3.Presence of moderate to severe co-morbid asthma 4.Patients with mild asthma having exacerbations within 30 days prior to trial inclusion 5.Patients with cystic fibrosis 6.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 (results not older than 12 months will be accepted) if clinically relevant 7.Clinically relevant perennial (e.g. house dust/-mite antigen) or actual seasonal allergic rhinitis 8.Rhinitis medicamentosa (drug induced rhinitis) 9.Aspirin-Exacerbated Respiratory Disease [AERD] (Aspirin sensitivity) 10.Dentogenic sinusitis or otherwise unilateral sinusitis 11.Presence of anatomical deviations of the nasal septum that significantly impair nasal and paranasal ventilation / airflow 12.Known hypersensitivity to trial medication or excipients 13.Patients with rare hereditary problems of fructose intolerance, galactose intolerance, lactase deficiency or glucose-galactose malabsorption or sucrase-isomaltase insufficiency 14.Signs or symptoms of acute bacterial sinusitis (e.g. fever > 38.5°C, orbital complications, severe unilateral frontal headache or toothache) 15.Treatment with systemic or nasal antibiotics or corticosteroids within the last 4 weeks prior to V1 16.Treatment with decongestant preparations (a-sympathomimetics), analgesics (including systemic Non-Steroidal Inflammatory Drugs [NSAIDs], except paracetamol), mucolytics / secretolytics, antihistamines, or alternative medicine preparations for treatment of common cold like symptoms or with immunomodulating properties within the last 7 days prior to V1 17.Other diseases within 5 years prior to V1, which 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 or alcohol or drug abuse or immunodeficiency) General: 18.Parallel participation in another clinical trial, participation in a trial within less than 6 weeks prior to trial entry, or previous participation in this clinical trial 19.Known to be, or suspected of being unable to comply with the clinical trial protocol (e.g. no permanent address, history of drug abuse, known to be non-compliant or presenting an unstable psychiatric history) 20.Legal incapacity and / or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the trial 21.Patients in custody by juridical or official order 22.Evidence of an uncooperative attitude 23.Patients who have difficulties in understanding the language in which the patient information is given 24.Patients who are members of the staff of the clinical trial site, staff of the sponsor or involved CRO, the investigator him- / herself or close relatives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: average MSS Visits 5 and Visit 6 (CRF data);Primary end point(s): The primary efficacy endpoint is defined as the average of investigator’s MSS ratings [score points] at V5 and V6 (arithmetic mean of 2 ratings): Investigator rated MSS - average over V5 and V6 [score points]; CRF data Major Symptom Score [MSS] (sum of rating scores for five individual rhinosinusitis symptoms, namely rhinorrhoea = anterior and posterior, nasal congestion, headache and facial pain / pressure) assessed by the investigator (MSSINV);Main Objective: To assess the efficacy of two dosages (240 mg and 480 mg per day) of a herbal medicinal product (BNO 1016) compared with placebo in the treatment of chronic rhinosinusitis in adults. ;Secondary Objective: To assess the safety and tolerability of 240 mg and 480 mg BNO 1016 compared with placebo during the 12-week treatment phase and the 8-week follow-up observation period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy(MSS), Quality of Life (QoL), Pharmacoeconomy, Tolerability. For detailed information please refer to the trial protocol chapter 3.3 (page 25) ;Timepoint(s) of evaluation of this end point: Please refer to the trial protocol chapter 3.3 (page 25). | — |
Countries
Germany, Poland
Contacts
Public ContactSenior Clinical Research Manager
Bionorica SE
Outcome results
None listed