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

Completed · Not applicable · Has a placebo group

Conditions studied: COPD Exacerbation

In brief

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.

Key facts

Study ID

NCT02291016

Run by

University of Tennessee Graduate School of Medicine

People needed

7

Starts

2015-02-01

Expected to finish

2016-03-01

Last updated by the study team

2019-03-19

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Tennessee Medical Center — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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