Efficacy and safety of aclidinium bromide at two dose levels vs placebo when administered to patients with moderate to severe chronic obstructive pulmonary disease (COPD)
- Conditions
- Moderate to severe chronic obstructive pulmonary disease (COPD)MedDRA version: 9.1Level: LLTClassification code 10009033Term: Chronic obstructive pulmonary disease
- Registration Number
- EUCTR2009-011600-27-CZ
- Lead Sponsor
- aboratorios Almirall, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 810
1. Males and non-pregnant, non-lactating females aged = 40.
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 (Visit 1) (i.e., 100xpost-salbutamol FEV1/FVC <70%).
3. Patients whose FEV1 at Screening Visit measured between 10-15 min post inhalation of 400 µg of salbutamol is = 30% <80% of the predicted normal value (i.e., 100xobserved post-salbutamol FEV1/ predicted FEV1 <80%).
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. Patients must be able to perform repeatible pulmonary function testing for FEV1 according to ATS/ERS 2005 criteria at Screening Visit (Visit 1).
5. Current or former cigarette smokers with a smoking history of at least 10 packs-year. 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. Female patients at least 1 year post-menopausal, surgically sterile (defined as having a hysterectomy or tubal ligation), or practicing a medically acceptable method of contraception. Women of childbearing potential must have a negative pregnancy test at Screening (Visit 1) and be using either double-barrier contraception or a barrier method plus a spermicidal agent.
7. 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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 (Visit 1). 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 defined as:
•Known active tuberculosis.
•History of interstitial lung or pulmonary thromboembolic disease.
•Pulmonary resection or lung volume reduction surgery during the past 12 months.
•History of bronchiectasis secondary to respiratory diseases others than COPD (e.g., cystic fibrosis, Kartagener’s syndrome, etc).
•Post organ 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. Body Mass Index (BMI) = 40.
7. Patients who have participated in an acute pulmonary rehabilitation program within the previous 6 months (NOTE: Patients on a stable pulmonary rehabilitation exercise regimen for at least 6 weeks are not excluded).
8. Clinically significant cardiovascular conditions defined as:
•Myocardial infarction during the previous 6 months.
•Unstable angina, unstable arrhythmia which has required changes in the pharmacological therapy or other intervention 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) as per the New York Heart Association.
9. Patients with non-controlled history of infection with human immunodeficiency virus (HIV) and/or active hepatitis.
10. Patients who have a resting systolic blood pressure = 200 mm Hg, a resting diastolic blood pressure = 120 mm Hg, or a resting heart rate = 105 bpm at Screening Visit (Visit 1) or Visit 2 (pre-randomization).
11. QTc [calculated according to Bazett’s formulae (QTc=QT/RR1/2), as indicated in the paper tracing generated by the equipment used to record the ECGs] above 470 milliseconds in the ECG performed at Screening Visit (Visit 1).
12. 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 evaluation (Visit 1), if the abnormality defines a disease state listed as an exclusion criteria, except for those related to COPD.
13. Patients with a history (within the previous 5 years) of drug and/or alcohol abuse that may prevent compliance with trial activities.
14. 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.
15. Patients with a history of hypersensitivity reaction to inhaled anticholinergics, sympathomimetic amines, or inhaled medication or any component t
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method