A multiple dose, double blind, double-dummy, two-week 3 way cross-over, placebo-controlled clinical trial to assess the efficacy and safety of twice daily inhaled Aclidinium-bromide 400 µg compared to placebo and to an active comparator in patients with stable moderate to severe chronic obstructive pulmonary disease (COPD)
- Conditions
- patients with stable moderate to severe chronic obstructive pulmonary disease (COPD) will be included.MedDRA version: 11.1Level: LLTClassification code 10009033Term: <Manually entered code. Term in E.1.1>
- Registration Number
- EUCTR2008-006886-10-DE
- Lead Sponsor
- aboratorios Almirall, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Males and non-pregnant, non-lactating females aged = 40. Women of childbearing potential are allowed to enter the trial ONLY if they use one medically approved (i.e., mechanical or pharmacological) contraceptive measure. 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. All women of childbearing potential must have a negative pregnancy test at the screening
visit. For those females of childbearing potential who are unwilling to use contraceptive measures, they must provide a signed statement ensuring that they will not get pregnant throughout the study.
2. Patients with a clinical diagnosis of COPD, according to the GOLD guidelines:
(http://www.goldcopd.com) and stable airway obstruction.
3. Patients with a post-salbutamol FEV1 equal to or greater than 30% of the predicted value and less than 80% of the predicted value (i.e., 30% = 100xobserved post-salbutamol FEV1/ predicted FEV1 <80%) FEV1 at screening visit will be measured between 10-15 min post inhalation of 400 µg of salbutamol. Predicted normal values to be used for calculation purposes are to be based on
European Community for Steel and Coal predicted values.
4. Post-salbutamol FEV1/FVC < 70% at screening visit (i.e,. 100xpost-salbutamol FEV1/FVC < 70%).
5. Current, or ex-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-years history).
Patients smoking other tobacco types will not be allowed, unless they meet the cigarette criterion as well.
6. Patients whose COPD symptoms and FEV1 values at the time of randomisation are stable
compared to the Screening visit, according to the investigator’s medical judgment.
7. Patients who are eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained to them.
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) no
F.1.3.1 Number of subjects for this age range
1. History or current diagnosis of asthma.
2. A respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the six weeks prior to the screening visit. Patients who develop a respiratory tract infection or exacerbation during the screening period will be discontinued from the trial prior to randomisation.
3. Patients who have been hospitalised for an acute COPD exacerbation in the 3 months prior to
screening visit.
4. Use of long-term oxygen therapy (= 15 hours/day).
5. Patients with a body mass index (BMI) = 40 kg/ m2.
6. Patients who have a resting systolic blood pressure = 200 mmHg, a resting diastolic blood pressure = 120 mmHg or a resting heart rate = 105 bpm at screening visit.
7. Clinically significant respiratory conditions defined as but not limited to:
• Known active tuberculosis.
• History of interstitial lung or pulmonary thromboembolic disease.
• Pulmonary resection during the past 12 months.
• History of life-threatening COPD.
• History of any bronchiectasis secondary to respiratory diseases others than COPD (e.g., cystic fibrosis, Kartagener’s syndrome, etc).
• Patients who in the investigator’s opinion may need pulmonary rehabilitation or a thoracotomy during the trial. Patients on a stable pulmonary rehabilitation program prior to entry and anticipated to be stable throughout the study can be enrolled.
• Lung cancer
8. Clinically significant cardiovascular conditions defined as but not limited to:
• Myocardial infarction during the last 6 months.
• 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.
• Thoracic surgery within the previous 24 months.
9. Patients for whom the use of anticholinergic drugs is contraindicated:
- Patients with a known symptomatic prostatic hypertrophy and/or bladder neck obstruction.
Patients with a diagnosis of these conditions but without symptoms due to stable concomitant medication for its treatment are allowed to enter trial.
- Patients with narrow-angle glaucoma.
10. Patients with any other serious or uncontrolled physical or mental dysfunction which at the discretion of the investigator could place the patient at higher risk derived from his/her participation in the study, could confound the results of the trial, or is likely to prevent the patient from complying with the requirements of the trial or completing the trial period.
11. QTc [calculated according to Bazett’s formula (QTc=QT/RR1/2) above 470 milliseconds in the ECGs performed at screening visit.
12. Patients who can not perform repeatable spirometry attempts at the screening visit (as stated in section 11.3.2.1 of the protocol).
13. History of untoward reactions to inhaled anticholinergics, sympathomimetic amines or inhaled medication or any component thereof (including report of paradoxical bronchospasm).
14. Patients unable to properly use a dry powder or pMDI inhaler device or unable to perform acceptable spirometry.
15. Clinically relevant abnormalities laboratory, ECG parameters (other than QTc), or physical examination results at the screeni
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