EUCTR2011-001524-38-AT进行中（未招募）不适用
EFFICACY AND SAFETY OF ACLIDINIUM BROMIDE/FORMOTEROL FUMARATE FIXED-DOSE COMBINATIONS COMPARED WITH INDIVIDUAL COMPONENTS AND PLACEBO WHEN ADMINISTERED TO PATIENTS WITH STABLE CHRONIC OBSTRUCTIVE PULMONARY DISEASE
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,575
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 945
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 630
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
- •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 (= 15 hours/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.
- •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.
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EFFICACY AND SAFETY OF ACLIDINIUM BROMIDE/FORMOTEROL FUMARATE FIXED-DOSE COMBINATIONS COMPARED WITH INDIVIDUAL COMPONENTS AND PLACEBO WHEN ADMINISTERED TO PATIENTS WITH STABLE CHRONIC OBSTRUCTIVE PULMONARY DISEASEEUCTR2011-001524-38-ITALMIRALL SA1,729