Pharmacokinetic, Safety and Tolerability Study of Aclidinium/Formoterol Fixed Dose Combination and Formoterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Completed · Phase 2
Conditions studied: Chronic Obstructive Pulmonary Disease (COPD)
In brief
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.
Key facts
- Study ID
- NCT01551888
- Run by
- AstraZeneca
- People needed
- 24
- Starts
- 2012-01-01
- Expected to finish
- 2012-03-01
- Last updated by the study team
- 2017-02-14
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Forest Investigative Site 001 — Spartanburg, South Carolina, United States
Full record on ClinicalTrials.gov
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