Efficacy of Aclidinium Bromide Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients

• Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 12-24hr at Day 15 on Treatment [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
• Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24 hr at Day 15 on Treatment [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
• Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC0-12) in Liters at Day 1 on Treatment [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
• Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 12-24 hr at Day 1 on Treatment [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
• Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24 hr at Day 1 on Treatment [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
• Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-12 hr at Day 15 on Treatment [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
• Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 12-24 hr at Day 15 on Treatment [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
• Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-24 hr at Day 15 on Treatment [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
• Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-12 hr at Day 1 on Treatment [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
• Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 12-24 hr at Day 1 on Treatment [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
• Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-24 hr at Day 1 on Treatment [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

• Changes from baseline in FVC, FEV1 and AUC. [ Time Frame: 15 days ] [ Designated as safety issue: No ]
• AEs, laboratory, ECG and vital signs [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]

The main purpose of this study is to evaluate the efficacy, safety and tolerability of multiple doses of inhaled aclidinium bromide in moderate to severe COPD patients.

• Drug: Aclidinium bromide 400 μg bid
  Aclidinium bromide 400 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 15 days.
• Drug: Tiotropium 18 μg once-daily
  Tiotropium 18 μg once-daily via inhalation by Handihaler® dry powder inhaler: 1 puff in the morning for 15 days.
• Drug: Placebo
  Inhaled placebo: 1 puff in the morning (placebo to tiotropium) or in the morning and evening (placebo to aclidnium) for 15 days.

• Experimental: Aclidinium 400 μg bid
  Aclidinium bromide 400 μg twice-daily by inhalation
  Intervention: Drug: Aclidinium bromide 400 μg bid
• Active Comparator: Tiotropium 18 μg once-daily
  Tiotropium 18 μg once-daily by inhalation
  Intervention: Drug: Tiotropium 18 μg once-daily
• Placebo Comparator: Placebo
  Placebo
  Intervention: Drug: Placebo

Inclusion Criteria:

• Adult male and female patients aged 40 with stable moderate to severe COPD (GOLD guidelines).
• Post-salbutamol (FEV1) < 80% and ≥ 30% of predicted normal value and Post-salbutamol FEV1/FVC < 70%.
• Current or ex smokers of 10 pack-years.

Exclusion Criteria:

• Patients with no history or current diagnosis of asthma.
• No evidence of an exacerbation within 6 weeks prior to the screening visit.
• No evidence of clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
• No contraindication to use of anticholinergic drugs such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.