Effect of Aclidinium/Formoterol on Lung Hyperinflation, Exercise Capacity and Physical Activity in Moderate to Severe COPD Patients

Exclusion Criteria

• •1. History or current diagnosis of asthma.
• •2. Any respiratory tract infection (including upper respiratory tract) or COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period.
• •3. Patients who have been hospitalised for an acute COPD exacerbation within 3 months prior to Visit 1 or during the run-in period.
• •4. Clinically significant respiratory conditions other than COPD.
• •5. Use of long-term oxygen therapy (≥ 15 hours/day).
• •6. Oxygen saturation ≤ 85% as measured by pulse oximetry during exercise testing at Visit 1, Visit 2 or Visit 3 prior to randomisation.
• •7. Patients with a Body Mass Index (BMI) ≥ 40kg/m2.
• •8. Patient who may need to start a pulmonary rehabilitation program during the study and/or who started/finished it within 3 months prior to Visit 1 or during the run-in period.
• •9. Patients with clinically significant cardiovascular conditions.
• •10. Patients with Type I or uncontrolled Type II diabetes, uncontrolled hypo-or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled or untreated hypertension.
• •11. Patient with known non-controlled history of infection with human immunodeficiency virus (HIV) and/or active hepatitis.
• •12. Patients with clinically relevant abnormalities in the results of the blood pressure, ECG, or physical examination at Visit 1.
• •13. Patients with any serious or uncontrolled physical or mental dysfunction that could place the patient at higher risk derived from his/her participation in the study or could confound the results
• •14. Patients with conditions other than COPD that may contribute to dyspnoea and exercise limitation or with contraindications to clinical exercise testing according to ATS recommendations for CPET
• •15. Patients with other relevant comorbidities that make the patient nor suitable to follow-up study procedures and/or could affect physical activity
• •16. Patients who cycled \< 2 minutes or \> 15 minutes during the constant work-rate exercise tests conducted at Visit 2 (Run-in Visit) or at Visit 3 even after adjustment of the work load.
• •17. Patients with history of hypersensitivity reaction to inhaled anticholinergics, sympathomimetic amines or inhaled medication or any component thereof (including report of paradoxical bronchospasm)
• •18. Patients for whom the use of anticholinergic drugs is contraindicated (acute urinary retention, symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma)
• •19. Patients unable to properly use a multidose dry powder inhaler or a pressurized metered-dose inhaler (pMDI).
• •20. Patients using any prohibited medication (including IMP within 30 days (or 6 half-lives, whichever is longer) before Visit 1) or who have not undergone the required washout period.
• •21. 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).
• •22. Patients who do not maintain regular day/night, waking/sleeping cycles (e.g., night shift workers, sleep apnea).
• •23. Patients unable to give their consent, or patients of consenting age but under guardianship, or vulnerable patients