Study to assess efficacy and safety of Aclidinium bromide and Aclidinium bromide/Formoterol fumarate in stabile COPD patients - AVANT

Exclusion Criteria

• - 1. Involvement in the planning and/or conduct of the study (applies to AstraZeneca staff and/or site staff) or patients employed by or relatives of the employees of the site or sponsor.
• - 2. Previous enrolment or randomisation in the present study
• - 3. History or current diagnosis of asthma
• - 4. Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation (including the mild COPD exacerbation) within 6 weeks prior to screening or during the run-in period
• - 5. Patients hospitalized for COPD exacerbation (an emergency room visit for longer than 24 hours will be considered a hospitalization) within 3 months prior to screening and during the run-in period
• - 6. Clinically significant respiratory conditions other than COPD
• - 7. Patients who in the Investigator’s opinion may need to start a pulmonary rehabilitation program during the study and/or patients who started/finished it within 3 months prior to screening
• - 8. Use of long-term oxygen therapy (≥15 hours/day)
• - 9. Patient who does not maintain regular day/night, waking/sleeping cycles including night shift workers
• - 10. Clinically significant cardiovascular conditions
• - 11. Patients with Type I or uncontrolled Type II diabetes, uncontrolled hypo-or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled or untreated hypertension
• - 12. Patients with QT corrected interval (QTc) using Fridericia formula (QTcF) (QTc=QT/ Duration in milliseconds between two R peaks of two consecutive QRS complexes (RR1/3) >470 msec as indicated in the centralised reading report assessed at Screening (Visit 1)
• - 13. Patients with clinically significant abnormalities in the clinical laboratory tests, ECG parameters (other than QTcF) or in the physical examination at Visit 1 (screening)
• - 14. Patients with abnormal liver function tests defined as Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), or total bilirubin ≥ 2.5 times upper limit of normal ranges at screening
• - 15. Patient with known non-controlled history of infection with human immunodeficiency virus and/or active hepatitis
• - 16. Patient with a history of hypersensitivity reaction to inhaled anticholinergic drugs, sympathomimetic amines, inhaled medication or any component thereof
• - 17. Patient with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention, or patients with symptomatic non-stable prostatic hypertrophy
• - 18. 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
• - 19. Any other serious or uncontrolled physical or mental dysfunction
• - 20. Patients with a history (within 2 years prior to Visit 1 (screening) of drug and/or alcohol abuse that may prevent study compliance based on the Investigator judgment
• - 21. Patients unlikely to be cooperative or cannot comply with the study procedures
• - 22. Patients treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to screening
• - 23. 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
• - 24. Patients unable to give consent, or patients of consenting age but under guardianship, or vulnerable patients
• - 25. Any other conditions that, in the Investigator’s opinion, might have indicated the patient to be unsuitable for the study