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

Phase 2

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Aclidinium/formoterol 400/12μg FDC	Aclidinium/formoterol 400/12μg	Aclidinium/formoterol 400/12μg fixed-dose combination (FDC), one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Almirall inhaler
Formoterol	Formoterol	Formoterol 12μg one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Foradil® Aerolizer®

Primary Outcome Measures

Name	Time	Method
Maximum Formoterol Plasma Drug Concentration (Cmax) Following a Single Dose	Day 1: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (5 min before PM dose) and 5 and 15 min post PM dose	The standard deviation of the measure is expressed as the coefficient of variation (%)
Area Under the Formoterol Plasma Concentration Versus Time Curve (AUC) Over Dosing Interval at Steady State	Day 1: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (5 min before PM dose) and 5 and 15 min post PM dose; Days 2-4: 0, 5 and 15 min post dose; Day 5: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (post AM dose)	The standard deviation of the measure is expressed as the coefficient of variation (%)
Maximum Formoterol Plasma Drug Concentration (Cmax) at Steady State	Day 1: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (5 min before PM dose) and 5 and 15 min post PM dose; Days 2-4: 0, 5 and 15 min post dose; Day 5: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (post AM dose)	The standard deviation of the measure is expressed as the coefficient of variation (%)

Secondary Outcome Measures

Name	Time	Method
Area Under the Formoterol Plasma Concentration Versus Time Curve (AUC) Over Dosing Interval Following a Single Dose	Day 1: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (5 min before PM dose) and 5 and 15 min post PM dose	The standard deviation of the measure is expressed as the coefficient of variation (%)