EUCTR2008-005707-26-DE进行中（未招募）不适用
Effect of beclomethasone dipropionate/formoterol fumarate (BDP+FF) administered as a fixed pMDI combination on lung impedance and exhaled nitric oxide in comparison with the fixed combination of budesonide and formoterol fumarate (Symbicort Turbohaler®). FLEX study (Foster fixed combination on Lung Impedance and Exhaled nitric oXide)A single-centre, randomized, double blind, double-dummy, two-way cross-over, repeated dose study
Chiesi Farmaceutici SpA0 个研究点目标入组 24 人开始时间: 2008年12月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
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. Written informed consent obtained
- •2. Adult male and female (=18 and =65 years)
- •3. Clinical diagnosis of Asthma according to Global Strategy for Asthma
- •management and Prevention (GINA) revised version 2007
- •4. Patients treated with inhaled corticosteroids equivalent to Budesonide 200
- •µg b.i.d. (with or without LABA), including fixed combination
- •5. FEV1 = 65% of the predicted normal value pre-bronchodilator
- •6. A documented positive response to the reversibility test, defined as an
- •improvement in FEV1 of at least 12% from baseline value and 200 ml 30
- •minutes after 4 puffs of inhaled salbutamol pMDI (400 µg) at screening or
- •within a year prior to screening and/or documented hyper-responsiveness to methacholine on bronchial challenge testing
- •7. FENO > 30 ppb at screening. If this test fails, it can be repeated once
- •(Screening Visit 1 rescheduled within 7 days. In this case, only NO
- •measurement will be re-performed)
- •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
- •1. Inability to carry out pulmonary function testing and NO testing;
- •2. Diagnosis of COPD as defined by the current GOLD guidelines (2006);
- •3. History of near fatal asthma;
- •4. Evidence of severe asthma exacerbation or symptomatic infection of the
- •airways in the previous 8 weeks;
- •5. More than two courses of oral corticosteroids or hospitalisation due to asthma
- •during the previous 6 months;
- •6. Current smokers or recent (less than one year) ex-smokers defined as smoking
- •more than 10 pack-years;
- •7. Clinically significant or unstable concurrent disease: e.g. uncontrolled
- •hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease;
- •significant hepatic impairment; significant renal impairment; significant other
- •pulmonary disease; cardiovascular disease; gastrointestinal disease;
- •neurological disease; haematological disease, autoimmune disorders, that may
- •interfere with patient’s safety, compliance, or study evaluations, according to
- •the investigator’s opinion;
- •8. Cancer or any chronic diseases with prognosis < 2 years;
- •9. Female subjects: pregnant or with active desire to be pregnant, lactating
- •mother or lack of efficient contraception in a subject with child-bearing
- •potential (i.e. contraceptive methods other than oral contraceptives, IUD, tubal
- •ligature). A pregnancy test in urine is to be carried out in women of a fertile
- •age at screening;
- •10. Significant alcohol consumption or drug abuse;
- •11. Patients treated with leukotrien modifiers, inhaled long-acting and shortacting
- •anticholinergics, monoamine oxidase inhibitors or beta-blockers as
- •regular use
- •12. Patients treated with tricyclic antidepressants or Selective Serotonin Reuptake
- •Inhibitors (SSRIs) unless already taken at stable doses at the screening
- •13. Patients treated with extrafine formulations of ICS or fixed combinations of
- •ICS and LABA
- •14. Allergy, sensitivity or intolerance to study drugs and/or study drug
- •formulation ingredients;
- •15. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study;
- •16. Patients who received any investigational new, not yet approved drugs within
- •the last 8 weeks.
研究者
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