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Clinical Study

Clinical Results

In a clinical study entitled, Efficacy and Safety of a New Acoustic Device, The Lung Flute®, for Sputum Induction in Healthy Non-smokers and Chronic Bronchitis, tested their hypothesis that expectorate samples obtained after induction with the Lung Flute® would have characteristics of lower respiratory tract secretion and would be comparable to sputum samples obtained by induction with hypertonic saline. The researchers found that samples from 100% of the chronic bronchitis patients obtained with the Lung Flute® contained lower respiratory secretions. Analysis also revealed that the samples obtained using the Lung Flute® and through hypertonic saline induction were not statistically different. The most common adverse event associated with use of the Lung Flute® was mild transient throat irritation. The researchers concluded, "The Lung Flute® presents a safe, effective, convenient and rapid method of sputum induction. Further investigation in its utility for diagnostic and therapeutic applications is warranted."

Cellular and biochemical characteristics of samples obtained with Lung Flute®

Parameter Saliva Median IQR Flute® Median IQR Hypertonic Saline IQR P Value
S vs F		 P Value
S vs H		 P Value
F vs H
Weight 0.37 0.342 1 1.36 4.5 6.415 0.3067 0.0001 0.0001
Cell Count (/mL) 50000 70000 247500 365000 280000 377500 0.0022 0.0019 0.81
Neutrophil (/mL) 19 403 98803 249566 178464 248701 0.0034 0.0005 0.64
Macrophages (/mL) 75 506 82385 130043 54926 70627 0.001 0.0005 0.18
Squamous Cells (/mL) 36000 60885 35219 70299 10950 34330 0.62 0.09 0.15
IL-8 (ng/mL) 0.38 0.78 1.61 1.56 1.46 1.6 0.008 0.01 0.81
Elastase (nM) 0.69 2.18 0.89 1.67 0.62 0.93 >0.99 0.67 0.16
Fibrinogen (ng/mL) 661 1531 822 1837 1914 3219 0.31 0.07 0.53

The Lung Flute’s® patented low frequency acoustic wave (LFAW) producing technology compares favorably to current standard-of-care hypertonic saline induction used to collect diagnostic sputum samples in patients with reduced pulmonary function. In a clinical trial in 15 subjects with chronic bronchitis collected sample cell counts, neutrophils, macrophages, squamous cells and IL-8 were not statistically different for the samples collected by the Lung Flute® and those inducted with hypertonic saline.