COPD Aerosol Study Comparing the Efficacy of Nebulizers Versus Dry Powder Inhalers

A Randomized, Double-Dummy, Crossover, Single-Center Study Comparing the Efficacy of Nebulizers Versus Dry Powder Inhalers in the Treatment of Patients Recovering From Severe Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to compare drug delivery and lung function after treatment with formoterol from a nebulizer versus a dry powder inhaler (DPI) in patients recovering from severe exacerbations of COPD. This is to determine if one device is superior in providing better lung function and drug deposition in this clinical setting.

Inclusion Criteria:

• Current or past cigarette smoking history of >/= 10 pack-years.
• FEV1/FVC ratio </= 70%.
• Known diagnosis of COPD.
• Current hospitalization for a primary diagnosis of acute exacerbation of COPD.
• Must be able to understand and willing to sign an informed consent document.

Exclusion Criteria:

• On a ventilator or mask ventilation.
• Allergy or contraindication to Formoterol use.
• Marked QTc prolongation (> 450 ms).
• Liver cirrhosis or chronic renal insufficiency (serum creatinine > 2 mg/dL).
• Atrial fibrillation with rapid ventricular response (heart rate > 110 bpm) or ventricular arrhythmia (frequent PVCs, ventricular tachycardia).
• Acute myocardial infarction within 12 weeks of patient study registration.
• Known pulmonary embolism.
• Known or suspected lung cancer.
• Known neuromuscular disease, stroke with residual hemiparesis, or untreated Parkinsonism
• Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm, or sub dermal implants).
• Inability to understand instructions.
• Participation in another investigational drug clinical trial within 30 days of patient study registration.