Pharmacokinetic, Safety and Tolerability Study of Aclidinium/Formoterol Fixed Dose Combination and Formoterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

A Phase 2a, Randomized, Open-Label, 2-Way Crossover Study To Determine The Pharmacokinetics, Safety, And Tolerability Of Aclidinium/Formoterol 400/12 µg Fixed Dose Combination Via Almirall Inhaler And Formoterol 12 µg Via Foradil® Aerolizer® In Patients With Moderate To Severe Chronic Obstructive Pulmonary Disease

The purpose of this Phase II study is to evaluate the pharmacokinetics, safety, and tolerability of aclidinium/formoterol fixed dose combination (FDC 400/12 μg via the Almirall Inhaler and formoterol 12 μg via the Foradil® Aerolizer®, both administered twice daily for five days to patients with moderate to severe COPD.

Inclusion Criteria:

• Current or former cigarette smokers with a cigarette smoking history of at least 10 pack-years
• A diagnosis of stable moderate to severe COPD and stable airway obstruction as defined by the Global Initiative for Chronic Obstructive Lung Disease guidelines and stable airway obstruction.

Exclusion Criteria:

• Patients who have been hospitalized for an acute COPD exacerbation within three months prior to Screening
• Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the six weeks before Screening
• Patients with any clinically significant respiratory conditions other than COPD
• Clinical history that suggests that the patient has asthma as opposed to COPD
• Chronic use of oxygen therapy ≥ 15 hours/day
• Patients with clinically significant cardiovascular conditions
• Patients with a history of hypersensitivity reaction to inhaled anticholinergics, beta-2 agonists, sympathomimetic amines, or inhaled medications