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

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Formoterol Fumarate

Criteria

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