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临床试验/EUCTR2011-001524-38-DE
EUCTR2011-001524-38-DE进行中（未招募）不适用

EFFICACY AND SAFETY OF ACLIDINIUM BROMIDE/FORMOTEROLFUMARATE FIXED-DOSE COMBINATIONS COMPARED WITH INDIVIDUALCOMPONENTS AND PLACEBO WHEN ADMINISTERED TO PATIENTS WITH STABLE CHRONIC OBSTRUCTIVE PULMONARY DISEASE

ALMIRALL, S. A.0 个研究点目标入组 1,733 人开始时间: 2011年8月17日最近更新:
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适应症

试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
1,733
研究概览入排标准研究者记录与标识符相似试验

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. Adult male or non-pregnant, non-lactating female aged =40. Women
  • •of childbearing potential are allowed to enter the trial if they show to have a negative serum pregnancy test at the Screening Visit and are using, during the last two months before the Screening Visit, at least one medically approved and highly effective method of birth control defined as those which result in a low failure rate (i.e less than 1% per year) when used consistently and correctly such as implants, injectables, oral contraceptives combined with at least one barrier method, hormonal IUDs, sexual abstinence or vasectomy of the partner. (A female is considered to be of childbearing potential unless she has had a hysterectomy, is at least one year post-menopausal or has undergone tubal ligation).
  • •2. Current or ex-cigarette smoker, with a smoking history of at least 10
  • •pack-years. Pack-years are calculated by dividing the number of cigarettes smoked per day by 20 (the number of cigarettes in a pack) and multiplying this figure by the number of years a person has
  • •smoked. For example, a person who smokes 40 cigarettes a day and has smoked for 10 years would have a 20 pack-year smoking history (40 cigarettes per day ÷ 20 cigarettes per pack = 2; 2 x 10 years of smoking = 20 pack-year history). (Patients smoking other tobacco types will not be allowed, unless they meet the cigarette criterion
  • •3. Patient with a clinical diagnosis of stable COPD according to the GOLD Guidelines at the Screening Visit (http://www.goldcopd.org).
  • •4. Patient whose FEV1/FVC at the Screening Visit measured between 10-15 minutes post inhalation of 400 µg of salbutamol is < 70% (i.e., 100 x Post-salbutamol FEV1 /FVC < 70%).
  • •5. Patient with a diagnosis of moderate to severe COPD according to the GOLD Guidelines classification (stages II and III) at the Screening Visit: FEV1 measured between 10-15 minutes post inhalation of 400 µg of salbutamol is 30% = FEV1 < 80% of the predicted normal value (i.e., 100 x Post-salbutamol FEV1/ Predicted FEV1 must be < 80% and =30%). (Predicted normal values to be used for calculation purposes are to be based on European Community for Steel and Coal predicted values (Quanjer et al. 199324)).
  • •6. Patient must be able to perform repeatable pulmonary function testing for FEV1 according to ATS/ERS 2005 criteria at Screening Visit.
  • •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 832
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 901

排除标准

  • •1. History or current diagnosis of asthma.
  • •2. Any respiratory tract infection (including the upper respiratory tract)
  • •or COPD exacerbation in the 6 weeks before Screening Visit.
  • •3. Patient hospitalised for COPD exacerbation within 3 months prior to
  • •Screening Visit.
  • •4. Clinically significant respiratory conditions defined as:
  • •Known active tuberculosis.
  • •History of interstitial lung or massive pulmonary thromboembolic disease.
  • •Pulmonary resection or lung volume reduction surgery within 12
  • •months prior to Screening Visit.
  • •History of lung transplantation.
  • •Patients who in the investigator's opinion may need thoracotomy or
  • •other lung surgery during
  • •History of bronchiectasis secondary to respiratory diseases others than COPD (e.g., cystic fibrosis, Kartagener's syndrome, etc).
  • •Known a1-antitrypsin deficiency.
  • •6. Use of long-term oxygen therapy (= 1 hour/day).
  • •7. Patient who does not maintain regular day/night, waking/sleeping
  • •cycles including night shift workers (e.g., history of sleep apnoea syndrome, any disease related with sleep disturbances such as restless-legs syndrome or somnambulism).
  • •8. Clinically significant cardiovascular conditions defined as:
  • •Myocardial infarction within the 6 months prior to Screening Visit.
  • •Thoracic surgery within 12 months prior to Screening Visit.
  • •Unstable angina or unstable arrhythmia meaning which has required
  • •changes in the pharmacological therapy or other intervention within 12 months prior to Screening Visit, or newly diagnosed arrhythmia within the previous 3 months prior to Screening Visit.
  • •Hospitalisation within 12 months prior to Screening Visit for heart
  • •failure functional classes III (marked limitation of activity and only comfortable at rest) and IV (need of complete rest, confinement to bed or chair, discomfort at any physical activity and presence of symptoms at rest) as per the New York Heart Association.
  • •9. Patient (with or without pharmacological therapy) with resting systolic blood pressure = 160 mmHg, a resting diastolic blood pressure = 100 mm Hg, or a resting heart rate = 105 bpm at Screening Visit and at Visit 1 pre-randomisation
  • •10. Patient with QTc [calculated according to Bazett formulae
  • •(QTc=QT/RR1/2) > 470 msec as indicated in the centralised reading report assessed at Screening Visit.
  • •11. Patient with clinically relevant abnormalities in the results of the
  • •clinical laboratory tests, ECG parameters (other than QTc Bazzet) or in the physical examination at the Screening Visit, if the abnormality defines a disease state listed as exclusion criteria, except for those related to COPD.
  • •12. Patient with a history of hypersensitivity reaction to inhaled
  • •anticholinergics, sympathomimetic amines, or inhaled medication or any component thereof (including report of paradoxical
  • •bronchospasm). Patient with known narrow-angle glaucoma, symptomatic bladder neck obstruction or acute urinary retention.
  • •13. Patient with symptomatic non-stable prostatic hypertrophy.
  • •(However, patients with wellcontrolled, stable, asymptomatic benign prostatic hypertrophy are not excluded).
  • •20. Patient unable to properly use a dry powder (DPI) or pressured
  • •metered-dose inhaler (pMDI) inhaler device or to perform spirometry measurements.

研究者

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