EUCTR2008-001773-15-GB进行中（未招募）不适用
A single centre, randomised, double-blind, double-dummy, placebo-and active-controlled, 3-way cross-over study to evaluate the 24 hour FEV1 profile of a single dose of CHF 5188 pMDI (400/4 mcg QD) (fixed combination budesonide/carmoterol 200/2 mcg) in adults patients with moderate or severe persistent asthma
Chiesi Farmaceutici SpA0 个研究点目标入组 42 人开始时间: 2008年7月15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
- 42
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. Male or female patients aged > or = 18 years
- •3. Patients with moderate or severe asthma not optimally controlled according to the GINA 2005 classification of asthma severity by daily medication regimen and response to treatment
- •4. Patients already treated with inhaled cortiscosteroids at stable dose for at least 4 weeks prior to inclusion
- •5. Patients with Forced Expiratory Volume in the first second (FEV1) = 50% and = 90% of predicted for the patient normal value and not less than 0.9 L in absolute value
- •6. Patients with a documented positive response to the reversibility test, defined as an increase of at least 12% and at least 200 mL from pre-dosing values in the measurement of FEV1 within 30 minutes after the inhalation of 400 µg salbutamol pMDI
- •7. Patients with a co-operative attitude and ability to be trained to correctly use the pMDI and the Turbuhaler®.
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients will not be enrolled at Visit 1 into the run-in period if they meet any of the following criteria:
- •1. Inability to carry out pulmonary function testing;
- •2. Diagnosis of COPD as defined by the current GOLD guidelines;
- •3. Current smokers or ex-smokers with total cumulative exposure equal or more than 5 pack-years and/or having stopped smoking one year or less prior to study start;
- •4. History of near fatal asthma or of a past hospitalisation for asthma in ICU;
- •5. Evidence of severe asthma exacerbation or symptomatic infection of the airways in the previous 4 weeks (e.g. oral corticosteroids intake);
- •6. Patients presenting with 3 or more asthma exacerbations in the previous year;
- •7. Hospitalisation due to asthma during the previous 8 weeks;
- •8. History of significant seasonal variation of asthma;
- •9. Patients treated with oral or intravenous corticosteroids in the past 4 weeks or depot injectable corticosteroids in the past 8 weeks;
- •10.Patients had used any of the following medications prior to screening and has not met the specified minimum wash-out period:
- •-short-acting ß2-agonists : 6 hours,
- •-long-acting ß2-agonists : 1 week,
- •-short-acting anticholinergics : 12 hours,
- •-long-acting anticholinergics (i.e. tiotropium bromide): 1 week,
- •-leukotriene modifiers : 4 weeks,
- •-fixed combinations of an anti-cholinergic and short-acting ß2 agonist (e.g. Duovent® and Berodual®) :12 hours,
- •-fixed combinations of an inhaled corticosteroid and long-acting ß2-agonist (e.g. Seretide®, Symbicort®) : 1 week,
- •-oral or nebulised bronchodilators : 4 weeks,
- •-nebulised corticosteroids : 4 weeks,
- •-xanthine derivative (e.g. theophylline) any formulation: 4 weeks,
- •-sodium cromoglycate or nedocromil sodium : 4 weeks;
- •11. Patients with a history or current evidence of heart failure, coronary artery disease, myocardial infarction, severe uncontrolled hypertension, cardiac arrhythmias or any other significant cardiovascular disease;
- •12. Patients presenting with a clinically significant abnormality at a 12-lead ECG or presenting a QTcB interval in ECG > 450msec (males) or > 470msec (females);
- •13. Patients presenting with serum potassium < 3.5 mmol/L or > 6.0mmol/L;
- •14. Patients presenting with fasting serum glucose > 8 mmol/L;
- •15. Patients with a clinically significant or uncontrolled concomitant disease: e.g. uncontrolled hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease; significant hepatic impairment; significant pulmonary disease (e.g. tuberculosis, lung cancer or other), gastrointestinal disease (e.g. active peptic ulcer or other), neurological disease, haematological disease, autoimmune disorders or other;
- •16. Patients with active cancer or a history of cancer with less than 5 years disease free survival time or any other chronic disease with poor prognosis and /or affecting patient status;
- •17. Pregnant or lactating females or females at risk of pregnancy, i.e. those not making use of an effective contraceptive method (oral contraception, IUD, double barrier method (spermicide + condoms or spermicide + diaphragm), tubal ligature). A pregnancy test will be performed at screening in women of childbearing potential;
- •18. Post-menopausal female not having amenorrhoea for at least 1 year;
- •19. Patients with a history of alcohol or drug abuse;
- •20. Patients with a known intolerance/hypersensitivity to beta2-aderenergic agonists, propellant gases/excipients;
- •21. Patients unlikely to comply with the protocol or una
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