EUCTR2013-003096-35-DE进行中（未招募）1 期
A multi-centre, randomised, placebo-controlled, double-blind, parallel-group study on the efficacy and safety of WF10 and its main constituents in patients with refractory allergic rhinitis
uvo Research GmbH0 个研究点开始时间: 2013年10月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •Subjects meeting all of the following conditions will be eligible for enrollment:
- •IN.1) Male and female outpatients (in female patients, see also item FEM.1-3 below)
- •IN.2) 18-70 years of age
- •IN.3) Body weight 45 – 110 kg (included)
- •IN.4) History of refractory rhinitis defined as persistence or recurrence of symptomatic episodes in spite of conventional treatment over the last one year before the screening (SCR) visit
- •IN.5) Positive allergen skin test to the relevant allergen(s) within the last two years before SCR
- •IN.6) Total nasal symptom score TNSS (see Section 6.1.1) = 6 (/12) (at the baseline visit [BL])
- •IN.7) ± controlled bronchial asthma provided it is stable and is not treated with more than low-to-medium dose inhaled corticosteroids
- •IN.8) Ability to read and understand German well enough to answer the scoring questions (TNSS, TOSS) and the Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) without translation or explanation
- •IN.9) Willing and able to provide informed consent
- •In order to be eligible, female patients also need to comply with all of the following criteria:
- •FEM.1) Non-pregnant
- •FEM.2) Non-lactating
- •FEM.3) Non-childbearing potential, while
- •o Surgically sterile
- •o OR post-menopausal for at least 6 months prior to the screening (SCR) visit
- •o OR having a negative pregnancy test at SCR and using a method of contraception with a low failure rate (PEARL Index) (i.e. less than 1% per year) when used consistently and correctly (including oral contraceptives, hormone implant, intrauterine device, male sexual partner(s) surgically sterile, abstinence)
- •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 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Subjects meeting any of the following criteria will be excluded from enrollment:
- •EX.2) Previous participation in the trial
- •EX.3) Participant in any other trial during the last 30 days
- •EX.4) Previous treatment with WF10 within the last two years
- •EX.5) Non-allergic rhinitis, rhinitis medicamentosa, idiopathic rhinitis or sinusitis; nasal surgery within the last 6 months before SCR; presence of a severely deviated septum, septal perforation, structural nasal defect or large nasal polyps causing obstruction
- •EX.6) Uncontrolled bronchial asthma
- •EX.7) Any co-morbidity (or sign thereof) which might put the patient at undue risk or might confound the evaluation of the trial criteria (as based on the Investigator's evaluation of the screening data incl. ECG) in particular, but not limited to: relevant haematological, cardiovascular, hepatic, renal, neurological or psychiatric disease
- •EX.8) Clinical laboratory tests outside of the normal range to an extent that is to be considered clinically relevant including, but not limited to: liver enzymes > 3 times the upper limit of the normal range; haemoglobin lower than 110% of the lower limit of the gender specific normal laboratory range
- •EX.9) Glucose-6-phosphate dehydrogenase (G6PD) deficiency = class III i.e. = 60% activity
- •EX.10) Sickle-cell anaemia
- •EX.11) Present or recent treatment with prohibited medication (see Section 5.9)
- •EX.12) Patients with a completed series of anti-allergy immunotherapy concluded within the past year or who are still receiving such therapy
- •EX.13) Patients with unsuitable veins
- •EX.14) Planned travel outside the study region during the first month of the trial
- •EX.15) Patients unwilling or unable to keep the diary (as evaluated at BL)
- •EX.16) Patients with a baseline use (between SCR- and BL-visit) of rescue medication that is to be considered exaggerated and/or that reflects inadequate handling of the rescue medication (as evaluated at BL)
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