UB Trial Confirms Multiple Benefits of Lung Flute Use for COPD

The hand-held respiratory device “decreases the impact of the disease and improves patients’ quality of life,” says Sanjay Sethi, MD, professor of medicine and chief of pulmonary, critical care and sleep medicine.

Usually caused by smoking, chronic obstructive pulmonary disease, or COPD, is the third-leading cause of death in the nation. Characterized by the hypersecretion of mucus, the disease manifests as chronic bronchitis and emphysema.

The Lung Flute’s unique mechanism makes use of acoustic energy to help clear mucus from the lower respiratory tract.

Blowing into the flute causes a reed to oscillate, generating a sound wave that travels down the tracheobronchial tree and vibrates tracheobronchial secretions.

Sethi led a six-month study that followed 69 patients with COPD and chronic bronchitis at the Buffalo VA Medical Center. He directs the center’s COPD Study Clinic and is a staff physician with the Veterans Affairs Western New York Healthcare System.

The randomly selected patients in the Lung Flute group reported significant improvements in symptoms, including less difficulty breathing and less coughing and sputum production.

More than eight out of 10 patients (85 percent) who used the Lung Flute said they found the device efficacious and wanted to continue using it.

The researchers measured improvements through questionnaires as well as objective means, such as spirometry to assess lung function and the distance patients walked in six minutes.

Those using the Lung Flute reported better outcomes on both the Chronic COPD Questionnaire, used to assess changes in respiratory symptoms, and the St. George’s Respiratory Questionnaire, a quality-of-life measurement tool.

Researchers obtained a more comprehensive assessment through repeated administrations of the BODE index, a measure of body mass, airflow obstruction, dyspnea (difficult breathing) and exercise capacity.

Those using the Lung Flute had flat scores.

However, within the control group, BODE scores increased and symptoms did not improve.

The study confirms and extends the results of an eight-week study of 40 patients in 2010.

The study also points to another benefit: patients may experience fewer flare-ups of respiratory symptoms with use of the Lung Flute, Sethi notes.

The research team is planning longer-term studies to learn how the device affects these exacerbations — a key part of what makes COPD patients sicker and causes them to seek health care services.

The Lung Flute is the only device of its kind that has been extensively tested and has proved to benefit COPD patients.

The device, for example, proved superior for COPD when compared with a similar device developed for cystic fibrosis.

The UB team leads the world in investigating this promising aid to COPD treatment. "We have the biggest database by far on using the device in COPD because all therapeutic studies have been done here in Buffalo," says Sethi.

Sethi has led a series of clinical trials demonstrating the safety and efficacy of the Lung Flute, including those that have played a key role in Food and Drug Administration (FDA) approval.

Based in part on Sethi’s studies, the FDA has approved the device for diagnostic and therapeutic uses, including:

• airway clearance therapy for COPD and other lung diseases characterized by retained secretions and congestion
• obtaining deep-lung sputum samples for diagnosis via laboratory analysis

UB researchers are now studying the Lung Flute’s potential to improve asthma symptoms. Other centers are investigating the device’s ability to help diagnose tuberculosis and lung cancer.

The device is manufactured by Medical Acoustics of Orchard Park, which has partnered with UB medical researchers for more than a decade.

“We are very fortunate to have access to UB’s vast resources, including researchers of the caliber of Sanjay Sethi and his team,” says Chief Executive Officer Frank Codella. He praised Sethi as “one of the leading COPD research professionals in the nation.” 

Sethi sees his collaboration with Medical Acoustics as a win-win for patients and the manufacturer. “That’s the way academia and industry partnerships should work,” he says.

The study, “Lung Flute Improves Symptoms and Health Status in COPD With Chronic Bronchitis: A 26-Week Randomized Controlled Trial,” has been published in Clinical and Translational Medicine. Co-authors are: 

• Pamela K. Anderson, manager of the Clinical Trials Office in UB's Clinical and Translational Science Institute
• Jingjing Yin, PhD, who earned her doctorate in biostatistics at UB’s School of Public Health and Health Professions

The study was funded by Medical Acoustics and the UB Center for Advanced Biomedical and Bioengineering Technology, which receives state support through NYSTAR, a division of Empire State Development.