Clinical trial NCT02291016: COPD Aerosol Study Comparing the Efficacy of Nebulizers Versus Dry Powder Inhalers
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD Exacerbation
Keywords: COPD
chronic obstructive pulmonary disease
Lead sponsor: University of Tennessee Graduate School of Medicine
Sponsor class: OTHER
Collaborators: name: Mylan Specialty L.P.
First posted: 2014-11-14
Enrollment: 7
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 exacerbations of COPD. This is to determine if one device is superior in providing better lung function and drug deposition in this clinical setting.


Eligibility criteria: 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.

Primary outcomes:
measure: The Difference Between the Values of Area Under the Response Curve for FEV1
timeFrame: Baseline through study completion (visit 1 through visit 2)
Secondary outcomes:
measure: Percentage Change in Peak FEV1 From Baseline After Inhalation of Formoterol
timeFrame: From pre-dose formoterol (baseline 0hrs) to 30 minutes, 1,2, and 4 hours post dose at visit 1 and measured again at visit 2
measure: Absolute Increase in FEV1 From Baseline After Inhalation of Formoterol
timeFrame: Measured at visit 1 and visit 2 after dosing and all FEV1 testing has been completed
measure: Peak FEV1 Between the Two Devices (Nebulizer and DPI)
timeFrame: Measured from Start of visit 1 until the completion of visit 2
measure: Change in FEV1 as a Percentage of Predicted Normal After Inhalation of Formoterol
timeFrame: Baseline through study completion (visit 1 through visit 2)
measure: Area Under the Response Curve for FVC From Baseline Through Four Hours (AUC FVC0-4h) After Inhalation of Formoterol
timeFrame: Measured at visit 1 and again at the end of visit 2
measure: Percentage Change in Peak FVC From Baseline After Inhalation of Formoterol
timeFrame: Measured at visit 1 and again at the end of visit 2
measure: Peak FVC Between the Two Devices (Nebulizer and DPI)
timeFrame: Peak FVC at visit 1 will be compared to the peak FVC at visit 2 for any significant change.
measure: Change in Dyspnea Based on the Borg Dyspnea Scale for Shortness of Breath (Pre-dose Administration and 60 Minutes After Inhalation of Formoterol With a Nebulizer or a DPI)
timeFrame: Measured at visit 1 and again at the end of visit 2
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
Study officials:
affiliation: University of Tennessee Medical Center
name: Rajiv Dhand, MD
role: PRINCIPAL_INVESTIGATOR
References: