EUCTR2011-003623-35-PL进行中（未招募）不适用
A multicentre, randomized, double-blind, placebo-controlled, parallel group study to assess efficacy and safety of two dosages of a herbal medicinal product (dry extract BNO 1016) in patients with chronic rhinosinusitis - BNO-1016 Chronic Rhinosinusitis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Bionorica SE
- 入组人数
- 771
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 <1) method of contraception two weeks prior to trial inclusion and during the screening / treatment period of the clinical trial (vasectomised partner, sexual abstinence - the lifestyle of the female has to be such that there is complete abstinence from intercourse from two weeks prior to the first dose of trial medication until at least 72 hours after treatment -, implants, injectables, combined oral contraceptives, hormonal intrauterine devices or double-barrier methods, i.e. any double combination of intrauterine device, condom with spermicidal gel, diaphragm, sponge, and cervical cap).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 690
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 77
排除标准
- •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)
- •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
研究者
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