Long-term Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-Dose Combination

Inclusion Criteria

• 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 Intrauterine Devices (IUDs), sexual abstinence or vasectomy of the partner.
• Current or ex-cigarette smoker, with a smoking history of at least 10 pack-years.
• Patient with a clinical diagnosis of stable COPD according to the Global Initiative for Chronic Lung Disease "GOLD" Guidelines at the Screening Visit.
• Patient whose FEV1/FVC (Forced Vital Capacity) at the Screening Visit measured between 10-15 minutes post inhalation of 400 micrograms of salbutamol is 470 msec as indicated in the centralised reading report assessed at Screening Visit.
• Patients with clinically relevant abnormalities in the clinical laboratory tests, ECG parameters (other than QT interval corrected using Bazett's formula [QTcB]) or in the physical examination at screening, if the abnormality defined a disease state listed as exclusion criteria, except for those related to COPD.
• Patients with a history of hypersensitivity reactions to inhaled anticholinergics, sympathomimetic amines, or inhaled medication or any component thereof (including report of paradoxical bronchospasm). Patients with known narrow-angle glaucoma, symptomatic bladder neck obstruction or acute urinary retention.
• Patients with symptomatic non-stable prostate hypertrophy. (However, patients with well-controlled, stable, asymptomatic benign prostatic hypertrophy were not excluded).
• Patients with known uncontrolled history of infection with human immunodeficiency virus and/or active hepatitis.
• Current diagnosis of cancer other than basal or squamous cell skin cancer.
• Life expectancy of less than 1 year.
• Patients with any other serious or uncontrolled physical or mental dysfunction that, as judged by the Investigator, could have placed the patient at higher risk from his/her participation in the study, could have confounded the results of the study, or is likely to prevent the patient from complying with the requirements of the study, or completing the study.
• Patients with a history (within 2 years prior to screening) of drug and/or alcohol abuse that might have prevented study compliance based on the Investigator judgment.
• Patients unlikely to be cooperative (eg, take the medication, complete the Patient Diaries or attend the clinic at the required times).
• Patients unable to properly use a DPI or pMDI inhaler device or to perform spirometry measurements.
• Patients previously randomised in a study involving aclidinium bromide/formoterol FDC.
• Patients previously randomised in a study involving aclidinium bromide monotherapy except when participation finished at least 6 months before screening.
• Patients treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to screening.
• Patients who intended to use any concomitant medication not permitted by this protocol or who had not undergone the required washout period for a particular prohibited medication.
• Patients unable to give consent, or patients of consenting age but under guardianship, or vulnerable patients.
• Patients employed, or relatives of employees at the study centre, Almirall or Forest Laboratories.
• Any other conditions that, in the Investigator's opinion, might have indicated the patient to be unsuitable for the study.