BENEFITS OF ACLIDINIUM BROMIDE IN THE RELIEF OF COPD SYMPTOMS INCLUDING COUGH - M-34273-46

Exclusion Criteria

• 1. History or current diagnosis of asthma.
• 2. Patients who suffered from a moderate or severe COPD exacerbation in the last year prior to Visit 1 (Screening) or during the run-in period.
• 3. Patients who develop a respiratory tract infection within 6 weeks before Visit 1 (Screening) or during the run-in period.
• 4. Clinically significant respiratory and cardiovascular conditions thought to be contributing to cough or likely to interfere in the conduct of the study.
• 5. Patient who in the investigator’s opinion may need to start a pulmonay rehabilitation program during the study and/or patients who started/finished it within 3 months prior to Screening Visit.
• 6. Use of long-term oxygen therapy.
• 7. Patients in non-stable treatment with angiotensin-converting enzyme inhibitors or opiates.
• 8. Patients in treatment with mucolytics, antihistamines, expectorants or antitussive drugs including over-the-counter medication.
• 9. Patient who does not maintain regular day/night, waking/sleeping cycles including night shift workers.
• 10. Patient with clinically relevant abnormalities in the results of the physical examination at Visit 1 (Screening)
• 11. Patient with a history of hypersensitivity reaction to inhaled anticholinergics,sympathomimetic amines, or inhaled medication or any component thereof (including report of paradoxical bronchospasm).
• 12. Patient with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention, or patients with symptomatic non-stable prostatic hypertrophy.
• 13. Patient with known non-controlled history of infection with human immunodeficiency virus (HIV) and/or active hepatitis
• 14. Current diagnosis of cancer other than basal or squamous cell skin cancer
• 15. Patient with any other serious or uncontrolled physical or mental dysfunction
• 16. 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.
• 17. Patient unlikely to be cooperative or that can not comply with the study procedures
• 18. Patient treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to Visit 1 (Screening).
• 19. 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.
• 20. Any other conditions that, in the investigator’s opinion, might indicate the patient to be unsuitable for the study.