EUCTR2011-002665-38-ES进行中（未招募）不适用
A MULTIPLE DOSE, RANDOMISED, DOUBLE-BLIND, PLACEBO CONTROLLED, 2 PERIOD CROSSOVER CLINICAL TRIAL TO ASSESS THE EFFECT OF ACLIDINIUM BROMIDE 400 MCG BID ON EXERCISE ENDURANCE IN PATIENTS WITH STABLE MODERATE TO SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Males and non-pregnant, non-lactating females aged ? 40. Females at least 1 year post-menopausal, surgically sterile (defined as having a hysterectomy or tubal ligation), or practicing a medically approved and highly effective method of contraception. Women of childbearing potential must have a negative pregnancy test at the Screening Visit and have used it for at least 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.
- •2. Patients with a clinical diagnosis of stable moderate to severe COPD, according to the GOLD guidelines: (http://www.goldcopd.com) and stable airway obstruction. Post-salbutamol FEV1/FVC < 70% at Screening Visit (i.e., 100xpost-salbutamol FEV1/FVC <70%).
- •3. Patients whose FEV1 at Screening Visit measured between 10-15 min post inhalation of 400 ?g of salbutamol is ? 30% and <80% of the predicted normal value (i.e., 100xobserved post-salbutamol FEV1/ predicted FEV1 <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. 1993).
- •4. Functional residual capacity (FRC) measured by body plethysmography at Screening Visit ? 120% of predicted value.
- •Predicted normal values used for calculation purposes were to be based on European Respiratory Society (ERS) predicted values (Stocks et al 1995).
- •5. Current or former cigarette smokers 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 as well.
- •6. Patients who understand the study procedures and are willing to participate in the study as indicated by signing the informed consent
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
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 six weeks before Screening Visit. Patients who develop a respiratory tract infection or exacerbation during the run-in period will be discontinued from the trial before randomisation.
- •3. Patients who have been hospitalised for an acute COPD exacerbation within 3 months prior to Screening Visit.
- •4. Clinically significant respiratory conditions other than COPD, including:
- •? Known active tuberculosis.
- •? History of interstitial lung or pulmonary thromboembolic disease.
- •? Pulmonary resection or lung volume reduction surgery within 12 months prior to Screening Visit.
- •? History of bronchiectasis secondary to respiratory diseases others than COPD (e.g., cystic fibrosis, Kartagener?s syndrome, etc).
- •? History of lung transplantation.
- •? Patients who in the investigator?s opinion may need pulmonary rehabilitation or thoracotomy or other lung surgery during the trial.
- •? Patients with a history of a1-antitrypsin deficiency.
- •5. Use of long-term oxygen therapy (? 15 hours/day).
- •6. Oxygen saturation ? 85% as measured by pulse oximetry during exercise testing at Screening visit, Run in visit or Visit 1.
- •7. Patients with a Body Mass Index (BMI) ? 40kg/m2.
- •8. Patient who in the investigator?s opinion may need to start a pulmonary rehabilitation program during the study and/or patients who started/finished it within 3 months prior to Screening Visit.
- •9. Clinically significant cardiovascular conditions including:
- •? Myocardial infarction during the previous 6 months.
- •? Unstable angina, unstable arrhythmia that has required changes in the pharmacological therapy or other intervention (e.g. use of an automated implantable cardioverter-defibrillator) during the last 12 months, or newly diagnosed arrhythmia within the previous 3 months.
- •? Hospitalisation within the previous 12 months 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) according to the New York Heart Association.
- •10. Patients with a resting systolic blood pressure (SBP)? 200 mm Hg, a resting diastolic blood pressure (DBP)? 120 mm Hg, or a resting heart rate ? 105 bpm at Screening Visit or Visit 1.
- •11. Patients with non-controlled history of infection with human immunodeficiency virus (HIV) and/or active hepatitis.
- •12. QTc [calculated according to Fridericia?s formulae (QTc=QT/RR1/3)] above 470 milliseconds in the manual ECG reading performed at Screening Visit.
- •13. Patients with clinically relevant abnormalities in the results of the clinical laboratory tests, in ECG parameters other than QTc, or in the physical examination at the Screening Visit.
- •14. Patients with a history (within the previous 2 years) of drug and/or alcohol abuse that may prevent compliance with trial activities.
- •15. Patients with any other serious or uncontrolled physical or mental dysfunction that, as judged by the investigator, could place the patient at higher risk derived from his/her participation in the study, could confound the results of the study or is likely to prevent the patient from complying with the requirements of the study or completing the study.
- •16. Patients who could not perform repeatable pulmonary function testing for FEV1 according to ATS/ERS 2005 criteria, plethysmography attempts,
研究者
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