Long-term Efficacy and Safety of Aclidinium/Formoterol Fixed-Dose Combination

Inclusion Criteria:

• Adult male or non-pregnant, non-lactating female aged ≥40. Women of childbearing potential are allowed to enter the trial if they show to have a negative serum pregnancy test at the Screening Visit and are using, during the last two months before the Screening Visit, at least one medically approved and highly effective method of birth control defined as those which result in a low failure rate (i.e less than 1% per year) when used consistently and correctly such as implants, injectables, oral contraceptives combined with at least one barrier method, hormonal Intrauterine Devices (IUDs), sexual abstinence or vasectomy of the partner.
• Current or ex-cigarette smoker, with a smoking history of at least 10 pack-years.
• Patient with a clinical diagnosis of stable COPD according to the Global Initiative for Chronic Lung Disease "GOLD" Guidelines at the Screening Visit.
• Patient whose FEV1/FVC (Forced Vital Capacity) at the Screening Visit measured between 10-15 minutes post inhalation of 400 micrograms of salbutamol is < 70% (i.e., 100 x Post-salbutamol FEV1 /FVC < 70%).
• Patient with a diagnosis of moderate to severe COPD according to the GOLD Guidelines classification (stages II and III) at the Screening Visit: FEV1 measured between 10-15 minutes post inhalation of 400 micro grams of salbutamol is 30% < FEV1 < 80% of the predicted normal value (i.e., 100 x Post-salbutamol FEV1/ Predicted FEV1 must be < 80% and ≥ 30%).
• Patient must be able to perform repeatable pulmonary function testing for FEV1 according to American Thoracic Society/European Respiratory Society "ATS/ERS" 2005 criteria at Screening Visit.
• Patient who is eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained.

Exclusion Criteria:

• History or current diagnosis of asthma.
• Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks before Screening Visit.
• Patient hospitalised for COPD exacerbation within 3 months prior to Screening Visit.
• Clinically significant respiratory conditions defined as: Known active tuberculosis.

• History of interstitial lung or massive pulmonary thromboembolic disease.

  • Pulmonary resection or lung volume reduction surgery within 12 months prior to Screening Visit.
  • History of lung transplantation.
  • History of bronchiectasis secondary to respiratory diseases others than COPD (e.g., cystic fibrosis, Kartagener's syndrome, etc).
  • Known a1-antitrypsin deficiency.
• Use of long-term oxygen therapy (≥ 15 hours/day).
• Clinically significant cardiovascular conditions changes in the pharmacological therapy or other intervention within 12 months prior to Screening Visit, or newly diagnosed arrhythmia within the previous 3 months prior to Screening Visit.
• Hospitalisation within 12 months prior to Screening Visit for heart failure functional classes III (marked limitation of activity and only comfortable at rest) and IV (need of complete rest, confinement to bed or chair, discomfort at any physical activity and presence of symptoms at rest) as per the New York Heart Association.
• Patient with interval corrected for heart rate "QTc" [calculated according to formulae (QTc=QT/RR1/2) > 470 msec as indicated in the centralised reading report assessed at Screening Visit.