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
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - Any
Updated:4/21/2016
Start Date:January 2012
End Date:April 2012

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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
We found this trial at
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Spartanburg, South Carolina 29303
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