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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Aclidinium/formoterol 400/12μg; Drug: Formoterol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01551888

LAC-PK-01

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 2 patient groups

Aclidinium/formoterol 400/12μg FDC

Experimental group

Description:

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

Treatment:

Drug: Aclidinium/formoterol 400/12μg

Formoterol

Active Comparator group

Description:

Formoterol 12μg one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Foradil® Aerolizer®

Treatment:

Drug: Formoterol