EUCTR2007-000774-23-GB进行中（未招募）不适用
EVALUATION OF CARDIAC SAFETY, TOLERABILITY AND EFFICACY OF CUMULATIVE DOSES OF CHF5188 pMDI (FIXED COMBINATION BUDESONIDE/CARMOTEROL 200/1 µg) COMPARED TO SAME CUMULATIVE DOSES OF CARMOTEROL pMDI AND PLACEBO IN ASTHMATIC PATIENTSA MONOCENTER, RANDOMISED, DOUBLE-BLIND, 3-WAY, CROSS-OVER CLINICAL STUDY
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •·Written informed consent obtained;
- •·Male or female patients aged = 18 and < 70 years;
- •·Patients with a clinical diagnosis of persistent asthma according to the GINA 2005 Classification of Asthma Severity by Daily Medication Regimen and Response to Treatment”;
- •·Patients already treated with inhaled corticosteroids at a stable dose for at least 4 weeks prior to inclusion;
- •.Patients with forced expiratory volume in the first second (FEV1) less or equal to 90% of predicted for the patient normal value and not less than 0.9 L in absolute value;
- •·Patients with a documented positive response to the reversibility test, defined as ?FEV1 = 15% and = 200 mL over baseline, 30 minutes after 200 µg salbutamol pMDI;
- •·Patients with normal blood pressure (i.e. supine SBP = 140 mmHg, supine DBP = 90 mmHg);
- •·Patients with normal ECG with heart rate < 100 bpm and QTcB interval = 450msec for males and = 470msec for females;
- •·Patients with a co-operative attitude and ability to be trained to correctly use the pMDI.
- •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:
- •·Inability to carry out pulmonary function testing;
- •·Diagnosis of COPD as defined by the current GOLD guidelines;
- •·Current smoker or ex-smoker with total cumulative exposure equal or more than 5 pack-years and/or having stopped smoking one year or less prior to study start;
- •·History of near fatal asthma;
- •·Evidence of severe asthma exacerbation or symptomatic infection of the airways in the previous 4 weeks (e.g. oral corticosteroids intake);
- •·Patients presenting with 3 or more asthma exacerbations in the previous year;
- •·Hospitalisation due to asthma during the previous 8 weeks;
- •·Patients treated with oral or intravenous corticosteroids in the past 4 weeks or depot injectable corticosteroids in the past 8 weeks;
- •·Patients treated with short-acting ß2-agonists in the past 8 hours, long-acting ß2-agonists in the past 48 hours, short-acting anticholinergics in the past 12 hours, long-acting anticholinergics (i.e. tiotropium bromide) in the past 48 hours, leukotriene antagonists in the past 2 weeks;
- •·Patients treated with Duovent® and Berodual® in the past 12 hours;
- •·Patients treated with an inhaled combination drug (eg Seretide®, Symbicort®) in the past 48 hours;
- •·Patients who have changed their dose or formulation of inhaled corticosteroids during the previous 4 weeks;
- •·History or current evidence of heart failure, coronary artery disease, myocardial infarction, severe uncontrolled hypertension, cardiac arrhythmias or any other significant cardiovascular disease;
- •·Patients presenting with a clinically significant abnormality at a 12-lead ECG;
- •·Patients presenting with serum potassium < 3.5 mmol/L or > 6.0 mmol/L;
- •·Patients presenting with fasting blood glucose > 8 mmol/L;
- •·Clinically significant or unstable concomitant disease,
- •·Cancer or any other chronic disease with poor prognosis and /or affecting patient status;
- •·Pregnant or lactating females or females at risk of pregnancy, i.e. those not making use of an effective contraceptive method. A pregnancy test will be performed at screening in women of childbearing potential;
- •·History of alcohol or drug abuse;
- •·Allergy, sensitivity or intolerance to beta2-aderenergic agonists and/or study drug formulation ingredients;
- •·Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study;
- •·Patients who received any investigational new drug within the last 8 weeks.
研究者
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