EUCTR2014-000907-29-BG进行中（未招募）不适用
Efficacy and safety of Sinusitis Hevert SL tablets compared to placebo in adult patients with acute, uncomplicated rhinosinusitis.A multicenter, randomized, double-blind, placebo-controlled, parallel group phase IV study. - Sinusitis Study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 290
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
- •2. Male and female outpatients, aged =18 and =75 years
- •3. Diagnosis of acute, uncomplicated (or recurrent acute) rhinosinusitis
- •– characterized by Major Rhinosinusitis Symptom Score (MRSSinv) = 8 and = 15 points
- •–individual score for facial pain/pressure (on bending) = 1 (mild) and = 2 (moderate)
- •– with presence of symptoms =3 days prior to inclusion
- •Out of the 5 main rhinosinusitis symptoms, at least 3 must be present. Among these, the presence of nasal congestion and facial pain / pressure (on bending) is mandatory.
- •4. Women of childbearing potential: willingness to use contraception methods
- •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 230
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •a) Diseases
- •1. Chronic rhinosinusitis (i.e. all forms and causes of persistent chronic rhinosinusitis)
- •2. Polyposis nasi, recent history
- •3. Infection of dental origin in the maxilla
- •4. Cystic fibrosis, recent history
- •5. Anatomical deviations of the nasal septum that significantly impair nasal and paranasal ventilation / air flow
- •6. Acute symptoms of a known allergic rhinitis
- •7. History of smoking within the last two years prior to study enrolment or current smoking habits
- •8. Patients with asthma
- •9. Known hypersensitivity to study medication or excipients (asteraceae, lactose, allergy to bee venom, etc.)
- •10. Underlying diseases leading to a significant immune deficiency
- •11. Signs or symptoms of bacterial sinusitis requiring antibiotic treatment (e.g. fever >38.3°C, orbital complications, severe unilateral frontal headache or toothache)
- •12. Patients with progressive auto-immune diseases, tuberculosis, leukemia or leukemia-like diseases, multiple sclerosis, inflammatory diseases of the connective tissues, rheumatoid arthritis, Lupus erythematodes, HIV infection or other chronic viral diseases
- •13. Patients with untreated/unstable thyroid gland disorder (treatment should not include iodine supplementation)
- •14. Pre-menopausal women (last menstruation = 1 year prior to informed consent) who:
- •- are nursing or pregnant,
- •- or are of child-bearing potential and are not practicing an acceptable meth-od of birth control, or do not plan to continue using this method throughout the study. Acceptable methods of birth control include transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, double barrier methods, sexual abstinence and vasectomised partner.
- •15. Severe diseases of liver or kidney
- •16. Severe somatopathic, neurological and / or psychiatric diseases
- •17. Patients with malignant growth processes or cancer treatment within the last two years prior to study inclusion.
- •18. History of alcohol or drug abuse
- •b) Medication
- •1. Treatment with systemic or nasal antibiotics or nasal or systemic corticosteroids within the last 4 weeks prior to study inclusion
- •2. Treatment with alternative medicine preparations (homeopathical and phytotherapeutical drugs) for treatment of common cold like symptoms or with immunomodulating properties (such as Echinacea), within the last 7 days prior to study inclusion
- •3. Treatment with decongestant (alpha-sympathomimeticson the day of study inclusion within 5 hours prior to screening and during the study)
- •4. Chronic use of decongestant remedies
- •5. Treatment with immunosuppressive medication 8 weeks prior to study inclusion and during the study for any condition
- •6. Systemic antiviral treatment such as aciclovir; zanamivir, or oseltamivir within 30 days prior to study inclusion
- •7. Patients requiring antibiotic treatment for any condition at study entry
- •1. Parallel participation in any other clinical study or participation in another study within less than 6 weeks prior to study inclusion, or previous participation in this same study
- •2. Legal incapacity and / or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study
- •3. Patients in custody by juridical or official order
- •4. Patients who have difficulties in understanding the language (German) in which the patient information is given
- •5. Patients who are employees of a trial center, the CRO, the sponsor or its authorised
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