Study of aclidinium bromide/formoterol fumarate compared with salmeterol/fluticasone propionate in patients with chronic obstructive pulmonary disease (COPD)

Exclusion Criteria

• - History or current diagnosis of asthma
• - Development of a respiratory tract infection or COPD exacerbation within 6 weeks (or 3 months if hospitalisation was required) before the Screening Visit or during the run-in period
• - Clinically significant respiratory conditions
• - Type I or uncontrolled Type II diabetes, uncontrolled hypo- or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled or untreated hypertension
• - Patients who, in the investigator’s opinion, may need to start a pulmonary rehabilitation programme during the study and/or patients who started/finished it within 3 months prior to Screening Visit
• - Use of long-term oxygen therapy (≥15 hours/day)
• - Patients treated on daily basis with triple therapy (LABA+LAMA+ICS) within 4 weeks prior to the Screening Visit
• - Patient who does not maintain regular day/night, waking/sleeping cycles including night shift workers
• - Clinically significant cardiovascular conditions
• - Patient with clinically relevant abnormalities in the results of the clinical laboratory tests, ECG parameters or in the physical examination at the Screening Visit
• - 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, acute urinary retention, or patients with symptomatic non-stable prostatic hypertrophy
• - Patient with known non-controlled history of infection with human immunodeficiency virus (HIV) and/or active hepatitis
• - History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years other than basal or squamous cell skin cancer
• - Patient with any other serious or uncontrolled physical or mental dysfunction
• - Patient with a history (within 2 years prior to Screening Visit) of drug and/or alcohol abuse that may prevent study compliance based on investigator judgment
• - Patient unlikely to be cooperative or that can’t comply with the study procedures
• - Patient treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to Screening Visit
• - Patient who intend to use any concomitant medication not permitted by this protocol or who have not undergone the required stabilization periods for prohibited medication
• - Any other conditions that, in the investigator’s opinion, might indicate the patient to be unsuitable for the study