COPD PATIENTS BREATHE EASIER WITH LUNG FLUTE
Patients with chronic
obstructive pulmonary disease (COPD) report improved symptoms and health status
when they use a hand-held respiratory device called the Lung Flute®, according
to a new study by the University at Buffalo. Usually caused by smoking, COPD,
which includes chronic bronchitis and emphysema, is the third leading cause of
death in the U.S.
The Lung Flute,
manufactured by Medical Acoustics, (Buffalo), uses sound waves to break up
mucus in the lungs. The device allows patients to clear lung mucus simply by
blowing into the hand-held respiratory device, which produces a low frequency
acoustic wave.
Published on Sept. 23
in Clinical and Translational Medicine, the 26-week study
demonstrates that patients using the Lung Flute experience less difficulty
breathing and less coughing and sputum production than a control group, which
saw no change in COPD symptoms.
"This study
confirms that the Lung Flute improves symptoms and health status in COPD
patients, decreasing the impact of the disease on patients and improving their
quality of life," says Sanjay Sethi, MD, principal author of the study and
professor and chief, division of pulmonary, critical care and sleep medicine in
the Department of Medicine, UB School of Medicine and Biomedical Sciences.
The device is approved
by the Food and Drug Administration (FDA) to treat COPD and other lung diseases
characterized by retained secretions and congestion. It also is approved by FDA
to obtain deep lung sputum samples for "laboratory analysis and pathologic
examination."
Colleagues of Sethi's
in the UB medical school are now studying the Lung Flute for use in improving
symptoms in asthma. The device is also being investigated for diagnostic use in
tuberculosis and lung cancer.
The study followed 69
patients with COPD for six months; it was conducted at the Veterans Affairs
Western New York Healthcare System (Buffalo VA) by researchers at the UB
medical school.
"This study confirms
and extends the results of a previous, 8-week study of 40 patients that was
conducted in 2010 to obtain FDA approval for the Lung Flute," says Sethi,
whose clinical practice is at the Buffalo VA.
He has led a series of
clinical trials demonstrating the safety and efficacy of the Lung Flute,
including those that played a key role in the FDA's approval of the device for
diagnostic and therapeutic uses.
Improvement in the
current study was demonstrated by responses reported by patients on the Chronic
COPD Questionnaire, which assesses changes in COPD symptoms and the St.
George's Respiratory Questionnaire, which measures quality of life. On both
questionnaires, patients using the Lung Flute reported significant
improvements.
In addition, the
Body-Mass Index, Airflow Obstruction, Dyspnea and Exercise Capacity (BODE)
score was measured repeatedly in the study. "The BODE index provides a
more comprehensive assessment of COPD patients," explains Sethi. "As
the disease worsens, the BODE index goes up as it did in the control group. But
for patients using the Lung Flute, the BODE index stayed flat."
Sethi adds that the
study points to a potential decrease in exacerbations, flare-ups of respiratory
symptoms, as a result of using the Lung Flute. Researchers are planning
longer-term studies that will focus specifically on how the device affects
exacerbations, a key part of what makes COPD patients sicker and leads to
health care utilization.
Sethi notes that while
similar devices have been developed for cystic fibrosis, the Lung Flute is the
only one that has undergone extensive testing specifically for COPD patients.
In a previous study comparing a device developed for cystic fibrosis with the
Lung Flute, the Lung Flute was superior for COPD patients.
"All therapeutic
studies on using the Lung Flute for COPD have been done here in Buffalo,"
says Sethi. "We have the biggest database by far on using the device in
COPD. The Lung Flute is the only one that has been tested and been clearly
shown to benefit COPD patients."
The research is the
result of a partnership between UB and Medical Acoustics.
"Medical
Acoustics has worked closely with UB's medical school since the company's
founding in 2002," says Frank Codella, chief executive officer at Medical
Acoustics. "We are very fortunate to have had access to UB's vast
resources, including medical researchers of the caliber of Sanjay Sethi and his
team, to lead many of the Lung Flute's clinical trials.
"Dr. Sethi is
recognized as one of the leading COPD research professionals in the United
States," Codella continues. "His research has resulted in the Lung
Flute receiving FDA clearances for both obtaining deep lung sputum samples for
diagnostic use and for airway clearance therapy as well as a series of Phase IV
studies such as the one being reported this week."
Adds Sethi: "The
people at Medical Acoustics are open-minded and I was willing to help because I
saw an unmet medical need. Our relationship satisfies my goal of getting
therapies to patients, while it helps the company succeed, satisfying their
goals of creating a viable business. That's the way academia and industry
partnerships should work."
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