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 |
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.
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
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