Lung flute improves symptoms and health status in COPD with chronic bronchitis: A 26week randomized controlled trial.

Sanjay Sethi,Jingjing Yin,Pamela K Anderson

doi:10.1186/s40169-014-0029-y

Abstract

BackgroundChronic obstructive pulmonary disease (COPD) is characterized by mucus hypersecretion that contributes to disease related morbidity and is associated with increased mortality. The Lung Flute® is a new respiratory device that produces a low frequency acoustic wave with moderately vigorous exhalation to increase mucus clearance. We hypothesized that the Lung Flute, used on a twice daily basis will provide clinical benefit to patients with COPD with chronic bronchitis.MethodsWe performed a 26 week randomized, non-intervention controlled, single center, open label trial in 69 patients with COPD and Chronic Bronchitis. The primary endpoint was change in respiratory symptoms measured with the Chronic COPD Questionnaire (CCQ). Secondary endpoints included health status, assessed by the St. George Respiratory questionnaire (SGRQ), BODE (Body-Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity)index score and exacerbation frequency.ResultsWhile the control patients did not demonstrate any significant changes in the primary endpoint (CCQ change at 26 weeks of +0.01, p = 0.8), a trend (p = 0.08) to decrease (improvement) in the CCQ (-0.23 at 26 weeks) was seen with the Lung Flute. Furthermore, a significant improvement in the symptom domain of the CCQ was seen only with the lung flute (-0.42, p = 0.004). Health status (SGRQ) improvement, was also only seen with the Lung Flute (-3.23, p = 0.03). The BODE score increased in the control group (3.31 at baseline, 4.14 at 26 weeks), however it remained stable in the Lung Flute arm (3.16 at baseline and 26 weeks), with the changes from baseline being significantly different between the 2 arms (p = 0.01). There was a trend for less exacerbations in the Lung Flute group (p = 0.07). Adverse effects were minor, with only 1 patient discontinuing treatment because of lack of efficacy. Serious adverse effects seen were all determined to be unrelated to the device use.ConclusionsThe Lung Flute is a safe and effective treatment in COPD with chronic bronchitis, providing a wide array of benefits.ClinicalTrials.gov IdentifierNCT01186822

Highlights

Chronic obstructive pulmonary disease (COPD) is characterized by mucus hypersecretion that contributes to disease related morbidity and is associated with increased mortality
Mucus hypersecretion and impaired mucociliary clearance is prevalent in many patients with COPD, and contributes significantly to the morbidity and mortality of this disease [1,2]
Inclusion criteria were: a) between 30-80 yrs of age, b) presence of airflow obstruction by spirometry post-bronchodilator forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) ratio

Summary

Introduction

Chronic obstructive pulmonary disease (COPD) is characterized by mucus hypersecretion that contributes to disease related morbidity and is associated with increased mortality. The Lung Flute® is a new respiratory device that produces a low frequency acoustic wave with moderately vigorous exhalation to increase mucus clearance. When blown in to with an exhalation vigorous enough to make the reed oscillate, the Lung Flute generates a sound wave of 16 to 22 Hz with an output of 110 to 115 dB using 2.5 cms H2O of pressure. This sound wave has the ability to travel down the tracheobronchial tree and vibrate tracheobronchial secretions. The Lung Flute is currently FDA approved and available for patient use by a health care provider prescription for both these purposes

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