patients with stable moderate to severe chronic obstructive pulmonary disease (COPD) will be included. MedDRA version: 11.1 Level: LLT Classification code 10009033 Term:
Conditions
Sponsors
Laboratorios Almirall, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the efficacy of inhaled aclidinium bromide 400 µg BID in moderate to severe COPD patients. • To assess the safety and tolerability of multiple doses of inhaled aclidinium bromide 400 µg BID in the same target population.;Secondary Objective: ;Primary end point(s): Primary variable: Change from baseline in normalised FEV1 area under the curve over the 12-h period immediately after morning IMP administration, AUC0-12, at Day 15 on treatment The secondary efficacy variables will be the following: 1) Change from baseline in normalised FEV1 AUC0-12 at Day 1 on treatment 2) Change from baseline in normalised FVC AUC0-12 at Days 1 and 15 on treatment 3) Change from baseline in normalised FEV1 AUC0-24at Days 1 and 15 on treatment 4) Change from baseline in normalised FVC AUC0-24 at Days 1 and 15 on treatment 5) Change from baseline in normalised FEV1 AUC12-24 at Days 1 and 15 on treatment 6) Change from baseline in normalised FVC AUC12-24 at Days 1 and 15 on treatment 7) Change from baseline in morning pre-dose FEV1 at Days 1 and 15 on treatment 8) Change from baseline in morning pre-dose FVC at Days 1 and 15 on treatment 9) Change from baseline in evening pre-dose FEV1 at Days 1 and 15 on treatment 10) Change from baseline in evening pre-dose FVC at Days 1 and 15 on treatment 11) Change from baseline in FEV1 after 23 and 24 hours of morning dosing at Day 15 on treatment 12) Change from baseline in FVC after 23 and 24 hours of morning dosing at Day 15 on treatment 13) Change from baseline in morning peak FEV1 at Days 1 and 15 on treatment 14) Change from baseline in morning peak FVC at Days 1 and 15 om treatment 15) Change from baseline in evening peak FEV1 at Days 1 and 15 on treatment 16) Change from baseline in evening peak FVC at Days 1 and 15 on treatment 17) Change from baseline in FEV1 at each specific time-point at Days 1 and 15 on treatment 18) Change from baseline in FVC at each specific time-point at Days 1 and 15 on treatment. 19) | — |
Countries
Germany
Outcome results
None listed