Status:
COMPLETED
COPD Aerosol Study Comparing the Efficacy of Nebulizers Versus Dry Powder Inhalers
Lead Sponsor:
University of Tennessee Graduate School of Medicine
Collaborating Sponsors:
Mylan Specialty L.P.
Conditions:
COPD Exacerbation
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
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 exacerbati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT02291016
Start Date
February 1 2015
End Date
March 1 2016
Last Update
March 19 2019
Active Locations (1)
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1
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920