EUCTR2006-000038-11-HU进行中（未招募）不适用
EVALUATION OF THE EFFICACY, SAFETY AND TOLERABILITY OF THE CONCURRENT ADMINISTRATION OF CHF 4226 HFA pMDI AND EXTRAFINE BUDESONIDE HFA pMDI, BOTH GIVEN ONCE OR TWICE DAILY (2µg + 200µg qd or 1µg + 100µg bid) OVER AN 8-WEEK RANDOMIZED DOUBLE-BLIND TREATMENT PERIOD IN ADULT PATIENTS WITH MODERATE PERSISTENT ASTHMA AND PRESENTING WITH SYMPTOMS ON EXISTING INHALED CORTICOSTEROID THERAPY.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 304
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
- •Patients will be enrolled at Visit 1 into the run-in period if they meet all of the following criteria:
- •Written informed consent obtained;
- •Male or female patients aged > or equal to 18 years;
- •Moderate persistent asthma according to the GINA 2004 Classification of Asthma Severity by Daily Medication Regimen and Response to Treatment”, sub-optimally controlled on existing therapy;
- •Patients free of long-acting beta2 agonists treatment (LABAs) at least for 4 weeks before the screening visit and already treated for at least 1 month with inhaled corticosteroids at a stable dose corresponding to mild asthma severity (GINA 2004) (up to 500µg BDP CFC or equivalent);
- •Asthma not adequately controlled on existing therapy, defined as presence of asthma symptoms > once a week and nocturnal asthma symptoms > twice a month. These findings are to be confirmed at the end of the run-in period, taking into consideration the patient's recent medical history;
- •Forced expiratory volume in the first second (FEV1) > or equal to 60% and < 80% of predicted for the patient normal value;
- •Positive FEV1 reversibility test at the screening visit, defined as an increase of at least 15% and at least 200 mL from pre-dose value in FEV1 30 minutes following 4 puffs (4 x 100 µg) of inhaled salbutamol pMDI;
- •A documented FEV1 positive reversibility test as above, is acceptable if performed within 6 months of the screening visit ;
- •Non-smokers or ex-smokers with cumulative tobacco exposure < 5 pack-years [e.g. less than 1 pack cigarettes (i.e. 20 cigarettes) per day for 5 years or 2 packs cigarettes per day for 2.5 years] and who have stopped smoking for at least 1 year;
- •A co-operative attitude and ability to be trained to correctly use the pMDI and 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 one or more of the following criteria:
- •Inability to carry out pulmonary function testing;
- •Diagnosis of COPD as defined by the current GOLD guidelines;
- •History of near fatal asthma;
- •History of significant seasonal variation of asthma;
- •Asthma exacerbation or symptomatic infection of the airways in the previous 4 weeks or during the run-in period (e.g. oral corticosteroids intake, antibiotics);
- •Patients presenting with 3 or more asthma exacerbations in the previous 6 months;
- •Hospitalization due to asthma during the previous 8 weeks;
- •Patients who have been treated with oral or intravenous corticosteroids in the past 4 weeks or depot injectable corticosteroids in the past 8 weeks or during the run-in period;
- •Patients who have changed their dose or formulation of their inhaled corticosteroids during the previous 4 weeks or during the run-in period;
- •Patients who have been treated with a short-acting ß2-agonist in the past 8 hours;
- •Patients who have been treated with an oral ß2-agonist in the past 4 weeks;
- •Patients who have been treated with nebulized ß2-agonists, nebulized corticosteroids, inhaled anticholinergics, leukotriene modifiers, xanthine derivatives (e.g. theophylline any formulation) in the past 4 weeks or during the run-in period;
- •Patients who have been treated with sodium cromoglycate or nedocromil sodium in the past 12 hours or during the run-in period;
- •Patients who have been treated with an inhaled combination drug (eg Seretide®, Symbicort®, Duovent®, Berodual®) in the past 4 weeks or during the run-in period;
- •History or current evidence of heart failure, coronary artery disease, myocardial infarction, severe uncontrolled hypertension, cardiac arrhythmias or any other significant cardiovascular disease;
- •Patients with a QTc interval (Bazett’s formula) in the ECG test > 450 msec in males or > 470 msec in females;
- •Patients with serum potassium < 3.5mEq/L or > 6.0mEq/L;
- •Clinically significant or unstable 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;
- •Cancer or any other chronic disease with poor prognosis and /or affecting patient status;
- •Pregnant or lactating females or females at risk of pregnancy, who are not making use of an effective contraceptive method. A pregnancy test will be performed at screening in women of childbearing potential;
- •Patients who have been treated with monoamine oxidase inhibitors, tricyclic antidepressants, Selective Serotonin Re Uptake Inhibitors (SSRIs), long-acting antihistamines or beta-blockers in the past 48 hours or during the run-in period (if the patient is on a short acting antihistamine or SSRI treatment, she/he can be included in the study under the following 2 conditions : (i) a recent ECG while patient was on therapy with these medications demonstrate that the QTc interval is in normal range;(ii) these therapies are taken in an unchanged dose throughout the duration of the study);
- •Allergy, sensitivity or intolerance to study drug formulation or excipients;
- •Patients unlikely to comply with the protocol or unable to understand the nature, scope of the study but also the possible benefits or
研究者
相似试验
已完成
3 期
A STUDY TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF LORNOXICAM SR 16mg Vs LORNOXICAM 8mg IN ADULT PATIENTS WITH OSTEOARTHRITIS OF THE HIP AND/OR KNEECTRI/2009/091/000297Glenmark Pharmaceuticals Ltd.210
尚未招募
3 期
Study of Tuberculosis resistant to treatmentCTRI/2021/03/032189International Union Against Tuberculosis and Lung Disease
Unknown
3 期
Difluprednate 0.05% versus Prednisolone acetate 1% eye drops following phacoemulsification surgeryEye DiseasesPACTR202207762785564Suez Canal University Hospital800
进行中（未招募）
1 期
Evaluation of the effectiveness, safety, and tolerability of tapentadol PR versus a combination of tapentadol PR and pregabalin in subjects with severe chronic low back pain with a neuropathic pain componentsevere chronic low back pain with a neuropathic pain componentMedDRA version: 12.1Level: LLTClassification code 10024891Term: Low back painMedDRA version: 12.1Level: LLTClassification code 10054095Term: Neuropathic painEUCTR2010-019998-14-BEGrünenthal GmbH800
进行中（未招募）
不适用
Comparison of tapentadol PR and oxycodone/naloxone PREUCTR2012-002943-11-ITGrünenthal GmbH240