EUCTR2008-006927-29-DE进行中（未招募）不适用
A Double-blind, Placebo-controlled Study to Assess Pharmacodynamic and Clinical Efficacy of CYT003-QbG10 in Patients with Persistent Allergic Asthma Bronchiale
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- •Able and willing to provide written informed consent
- •Able and willing to complete all protocol requirements
- •18 to 65 years of age
- •History of persistent asthma according to GINA 2007 guidelines whose symptoms requiring long-term treatment with ICS
- •Positive skin prick test to at least one aero-allergen and anamnestically confirmed to cause asthma symptoms. In case of doubt the allergic nature of the asthma must be confirmed by nasal provocation with the suspected allergen.
- •FEV1 >60% of predicted value
- •FEV1 improvement >=12% after inhaled beta2-agonist (400 µg salbutamol) at screening
- •Airway responsiveness to methacholine (PC20 <8 mg/mL) at screening (prior to run-in phase)
- •On stable therapy with ICS equivalent to a dose of =500 µg BDP daily (short-acting beta2-agonists (salbutamol) as needed may be used throughout the whole study)
- •Clinically stable asthma or sufficiently controlled asthma at screening and prior to treatment phase as indicated by <1.5 mean points in the Asthma Control Questionnaire (ACQ)
- •Female participants must meet one of the following criteria:
- •- No reproductive potential due to menopause (one year without menses, in case of doubts serum FSH will be determined and must be >30 U/mL and estradiol must be <54.7pg/mL), hysterectomy, bilateral oophorectomy, or tubal ligation
- •- Patient agrees to consistently practice an effective and accepted method of contraception throughout the duration of the study and for 1 additional month after the last immunization (hormone-based, or intrauterine device, or double barrier contraception, i.e. condom + diaphragm, condom or diaphragm + spermicidal gel or foam)
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Use of oral corticosteroids within past 3 months
- •Hospitalization for asthma exacerbation within past 6 months
- •Uncontrolled asthma defined by ACQ =1.5 points at screening or prior to treatment phase
- •Intermittent or seasonal asthma not requiring ICS treatment
- •Regular use of long-acting beta2-agonists (LABA). All LABAs should be discontinued after informed consent and at least 48h prior to the screening procedure to ensure appropriate washout.
- •Smokers or quitters with a smoking history of >10 packyears (one package per day for 10 years)
- •Major surgery within 4 weeks prior to enrollment
- •Presence or history of relevant cardiovascular, renal, pulmonary, endocrine, autoimmune, dermatological (in particular psoriasis), neurological and psychiatric (in particular depression) and ocular disease (in particular keratitis) as judged by the investigator. For psoriasis, family history should also be clean.
- •Current diagnosis or history of malignancy; presence of suspicious lymphadenopathy or splenomegaly on physical examination
- •Confirmed or suspected current infection with HIV, HBV, or HCV
- •Presence of active infectious disease as judged by the investigator
- •History of recurrent invasive streptococcal or staphylococcal infections, or known interleukin-1 receptor-associated kinase 4 (IRAK 4) deficiency
- •Active autoimmune diseases
- •Pregnancy (based on positive urine test at screening visit) or lactation
- •Female planning to become pregnant during the study period
- •Blood donation or loss of > 400 mL within 8 weeks prior to inclusion
- •Vaccination planned during study treatment period
- •History of abuse of alcohol or other recreational drugs
- •Lactose intolerance
- •Any specific immunotherapy (SIT) planned during the whole study period or any former SIT within the last three years.
- •Treatment with anti-IgE antibodies within past 6 months
- •Use of any investigational drug within 30 days before enrolment, or planned use during the whole study period
- •Previous participation in a clinical trial with a Qb-based vaccine
- •Possible dependency of the patient on sponsor and/or investigator
研究者
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