A double-blind, placebo-controlled, crossover study to assess the effect of aclidinium bromide 400 μg bid on COPD symptoms and sleep quality after 3 weeks of treatment in patients with stable moderate-to-severe chronic obstructive pulmonary disease (COPD)

Exclusion Criteria

• - History or current diagnosis of asthma
• - Patients with moderate to severe sleep apnoea assessed at screening
• - Patients who develop a respiratory tract infection or COPD exacerbation within 6 weeks (or 3 months if hospitalisation was required) before the Screening Visit (Visit 1) or during the run-in period
• - Clinically significant respiratory conditions
• - Patients with Type I or uncontrolled Type II diabetes, uncontrolled hypo-or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled or untreated hypertension
• - Patients who may need to start a pulmonary rehabilitation program during the study and/or patients who started/finished it within 3 months prior to the Screening Visit
• - Use of long-term oxygen therapy (15 hours/day)
• - Patients who does not maintain regular day/night, waking/sleeping cycles including night shift workers
• - Clinically significant cardiovascular conditions
• - QTc >470 milliseconds in the manual ECG reading performed at Screening Visit
• - Patients with clinically relevant abnormalities in the opinion of the investigator at the Screening Visit (Visit 1) in the results of the clinical laboratory tests, ECG parameters or in the physical examination)
• - Patients with a history of hypersensitivity reaction to inhaled anticholinergics, long and short acting β2-agonists, sympathomimetic amines, or inhaled medication or any component there of (including report of paradoxical bronchospasm)
• - Patients with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention, or patients with symptomatic non-stable prostatic hypertrophy
• - Patients with known non-controlled history of human immunodeficiency virus (HIV) infection 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
• - Patients with any other serious or uncontrolled physical or mental dysfunction, or moderate-to-severe depression, as confirmed by Beck Depression Inventory (BDI-II) total score >28.
• - Patients with a history (within 2 years prior to the Screening Visit) of drug and/or alcohol abuse that may prevent study compliance based on investigator judgment
• - Patients unlikely to be cooperative or that can't comply with the study procedures.
• - Patients treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to the Screening Visit
• - Patients who intends 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